Clinical Trials
(ACT011)
A Phase 1/2 Study of Oral LOXO-292 in Patients with Advanced Solid Tumors, Including RET Fusion-Positive Solid Tumors, Medullary Thyroid Cancer, and Other Tumors with RET Activation (LIBRETTO-001)
Chair:
Dr. Herbert Loong
Eligibility:
Patients with RET-Fusion Non-Small Cell Lung Cancer, Medullary Thyroid Cancer, and Other Tumors with Increased RET ActivityObjectives:
Primary Objectives:(Phase 1 part) To determine MTD/recommended phase 2 dose ofLOXO292.
(Phase 2 part) To assess, for each phase 2 expansion cohort, the anti-tumor activity of LOXO-292.
Secondary Endpoints:
- To determine safety profile and tolerability, characterize PK properties, toxicities and preliminary anti-tumor activity of LOXO-292
Exploratory Objectives:
- To determine relationship between PK and drug effects.
- To evaluate the serum tumor markers before, during, and at the end of treatment with LOXO-292 (for thyroid cancers patients only)
- To characterize RET gene fusions and mutations by molecular analysis
- To collect patient reported outcomes (PRO) data to explore disease-related symptoms and health-related quality of life (HRQoL).
(ACT015)
A Multi-Center Expanded Access Program (EAP) for the Treatment of Patients with Locally Advanced or Metastatic Solid Tumors with Rearranged During Transfection (RET) Activation (LIBRETTO-201)
Chair:
Dr. Herbert Loong
Objectives:
The aim of study is to provide access to LOXO-292 for patients with locally advanced or metastatic solid tumors with activating RET alterations (and other evidence of RET activation) who are 18 years of age or older and to determine the safety profile and tolerability of LOXO-292.
(ACT016)
An open-label, multi-center, Phase IV, roll-over study in patients with ALK positive malignancies who have completed a prior Novartis-sponsored ceritinib (LDK378) study and are judged by the investigator to benefit from continued treatment with ceritinib
Chair:
Dr. Herbert Loong
Eligibility:
Inclusion Criteria (PDF):Exclusion Criteria (PDF):
Objectives:
Primary Objectives:To evaluate long term safety data (SAEs and AEs) by measuring the frequency and severity of AEs/SAEs
Secondary Objectives:
To evaluate clinical benefit as assessed by the investigator by measuring the proportion of patients with clinical benefit as assessed by the investigator at scheduled visits
(ACT017)
A Phase 1/2, Open-Label, Multi-Center, First-in-HumanStudy of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity ofTPX-0005 in Patients with Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3Rearrangements
Chair:
Dr. Herbert Loong
Eligibility:
1. Histologically or cytologically confirmed diagnosis of locally advanced, or metastatic solid tumor (including primary CNS tumors) that harbors a ROS1, ALK or NTRK1-3 gene fusion.2. Subjects must have a documented ROS1, ALK orNTRK1-3 gene fusion that has been identified by local testing AND that has been prospectively confirmed by a central diagnostic laboratory to determine molecular eligibility PRIOR to enrollment.
Objectives:
- ORR, as assessed by BICR usingRECIST 1.1, in each subject population expansion cohort
- The DOR, TTR and CBR will be assessed by BICR using RECIST 1.1
- The PFS and OS will be assessed by BICR using RECIST 1.1
- Intracranial ORR and CNS-PFS will be assessed by BICR
- Type, incidence, severity, timing, seriousness, and relatedness of AEsand laboratory abnormalities
- Pharmacokinetic parameters of repotrectinib
- Changes in Quality-of-Life andhealth status during repotrectinib treatment
(ACT020)
An open-label, multi-center rollover protocol for continued characterization of safety and tolerability for subjects who have participated in a Novartis-sponsored spartalizumab study as single agent or in combination with other study treatments
Chair:
Prof. Brigette Ma
Eligibility:
- Signed informed consent must be obtained prior to participation in the study.
- Subject is currently enrolled in a pre-defined Novartis-sponsored study and is receiving spartalizumab as single agent or in combination with other study treatment.
- Subject is currently deriving clinical benefit from the study treatment, as determined by the investigator.
- Subject has demonstrated compliance, as assessed by the investigator, with the parent protocol requirements.
- Subject is willing and able to comply with the scheduled visits and treatment plans.
Objectives:
To collect safety and tolerability data for spartalizumab as single agent or in combination with other study treatments. To allow subjects enrolled in a spartalizumab Novartis-sponsored study continued access to study treatment.
(ACT022)
Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination with Pembrolizumab in Advanced Cancer
Chair:
Prof. Brigette Ma
Eligibility:
1. Recurrent or metatstatic cervical squamous cell carcinoma2. EBV-negative lymphoma
3. EBV-positive nasopharyngeal carcinoma
4. Stage IIIB/IV squamous or nonsquamous non-small cell lung carcinoma
Inclusion Criteria and Exclusion Criteria
Objectives:
Primary Objectives:To evaluate the safety and tolerability of FLX475 as a single agent and in combination with pembrolizumab in subjects with advanced cancer.
To evaluate the anti-tumor activity of FLX475 as a single agent and in combination with pembrolizumab in subjects with advanced solid tumors.
Secondary Objectives:
To define the maximum tolerated dose (MTD) and/or RP2D of FLX475, both as a single agent and in combination with pembrolizumab.
To evaluate the PK profile of FLX475 alone and in combination with pembrolizumab.
To assess the effects of FLX475 alone or in combination with pembrolizumab on PD markers relating to drug mechanism of action.
To explore the relationships of PK and PD parameters to clinical drug activity.
To characterize the onset, magnitude, and durationof tumor control in subjects receiving FLX475 alone or in combination with pembrolizumab
(ACT027)
A First in-human, phase 1/2 study of CFI-402411, hematopoietic progenitor kinase-1 (HPK1) inhibitor, as a single agent and in combination with pembrolizumab in subjects with advanced solid malignancies
Chair:
Prof. Brigette Ma
Eligibility:
Adult patients who have histological or cytological confirmation of advanced solid malignancies that are refractory to or subjects who are not candidate for current standard treatment(s) and for whom no standard therapy is available.Objectives:
To assess the safety and tolerability of treatment with CFI-402411 when administered orally as a single agent or combination with pembrolizumab to subjects with advanced solid malignancies.
(ACT030)
A phase Ib/II open-label, multi-center dose escalation study of JDQ443 in patients with advanced solid tumors harboring the KRAS G12C mutation (CJDQ4433A12101)
Chair:
Dr. Herbert Loong
Eligibility:
Adult patients with advanced (metastatic or unresectable) KRAS G12C mutant solid tumors who have received and failed standard of care therapy or are intolerant or ineligible to approved therapies, willing to undergo a tumor biopsy at screening if medically feasible.Objectives:
To assess the safety and tolerability of JDQ443 single agent and JDQ443 in combination with TNO155, JDQ443 in combination with spartalizumab, and JDQ443 in combination with TNO155 and spartalizumab, and to identify the maximum tolerated dose and/or recommended dose and regimen for future studies..
(ACT034)
Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (Tapistry) Phase II Platform Trial
Chair:
Dr. Herbert Loong
Eligibility:
Patient must have NGS test result with histologically or cytologically confirmed diagnosis of advanced and unresectable or metastatic solid malignancy. Patients must have reasonable hematologic and liver and renal function.Objectives:
To evaluate the efficacy of study treatment in patients with alteration/biomarker-positive advanced or metastatic solid tumors (for tumor types that are assessed by RECIST v1.1).
(ACT036)
A phase I, open-label, multi-center study of KFA115 as a single agent and in combination with tislelizumab in patients with select advanced cancers
Chair:
Prof. Brigette Ma
Eligibility:
1. Adult patients with advanced or metastatic disease who have progressed despite having received standard therapy in the metastatic setting or are intolerant to standard therapy, and/or for whom effective standard therapy is not available.2. Patients with non-small cell lung cancer, renal cell carcinoma, and cutaneous melanoma, who have received prior anti-PD-(L)1-containing therapy, and patients with ovarian cancer, nasopharyngeal cancer, anal cancer, thymic carcinoma, MSI-H colorectal cancer (CRC), esophagogastric cancer, mesothelioma, or head and neck squamous cell carcinoma (HNSCC), who are naive to anti-PD-(L)1 therapy will be included in the trial.
3. Patients must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution’s guidelines.
Objectives:
To characterize the safety and tolerability, and preliminary anti-tumor activity of KFA115 in combination with tislelizumab in patients with select advanced cancers.
(ACT037)
A Phase 1/2 open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of OTX-2002 as a single agent and in combination with standard of care in patients with hepatocellular carcinoma and other solid tumor types known for association with the MYC oncogene
Chair:
Prof. Stephen Chan
Eligibility:
Dose Escalation Cohort:Patients with metastatic, advanced (non-resectable), or recurrent solid tumor types known for association with the MYC oncogene who progressed on, relapsed after, are refractory to, or intolerant of standard of care for which no alternative standard treatment exists.
Dose Expansion in HCC:
Patients with radiographically, histologically, or cytologically confirmed hepatocellular carcinoma with BCLC Stage B or C disease that is not amenable to locoregional therapy, refractory to locoregional therapy or not amenable to curative treatment approach. Participant must have received at least 1, but no more than 3 prior systemic therapies for HCC, and without available subsequent standard of care.
Objectives:
Dose Escalation and Safety Run-in:Primary Objectives:
Determine the DLTs, MTD, safety, and tolerability and determine the RDE of OTX-2002 in participants with HCC as a single agent and in combination
Secondary Objectives:
- Determine the preliminary antitumor activity of OTX-2002 as a single agent and in combination
- Determine the PK of OTX-2002 as a single agent and in combination
Dose Expansion in HCC:
Primary Objectives:
Determine the preliminary antitumor activity of OTX-2002 as a single agent and in combination
Secondary Objectives:
- Determine the safety and tolerability of OTX-2002 in combination in participants with HCC
- Evaluate the PFS of OTX-2002 as a single agent and in combination
- Evaluate the TTP of OTX-2002 as a single agent and in combination
- Evaluate the TTR of OTX-2002 as a single agent and in combination
- Evaluate the OS of OTX-2002 as a single agent and in combination
(ACT038)
A phase 1/1b/2 study of AMG 193 alone and in combination with docetaxel in subjects with advanced MTAP-null solid tumors
Chair:
Dr. Herbert Loong
Eligibility:
- Evidence of homozygous loss of CDKN2A (null) (Parts 1a and 1b only) and/or MTAP (null) in the tumor tissue or blood (Parts 1a to 1h, Parts 2a and 2b) or lost MTAP expression in the tumor tissue (Parts 1a to 1h, Parts 2a and 2b).
- Histologically confirmed metastatic or locally advanced solid tumor not amenable to curative treatment with surgery and/or radiation.
- Squamous/ adenocarcinoma NSCLC, cholangiocarcinoma, HNSCC, pancreatic adenocarcinoma.
Objectives:
- Parts 1 and 2
- To evaluate the safety, tolerability, and to determine the MTD or RP2D of AMG 193 alone and in combination with docetaxel in adult subjects with metastatic or locally advanced MTAP-null solid tumors.
- To characterize the PK of AMG 193 alone and in combination with docetaxel. To evaluate ORR, DCR, DoR, TTR, duration of SD, PFS, and OS of AMG 193 alone and in combination with docetaxel in adult subjects with MTAP-null solid tumors.
- To evaluate the effect of Drug Substance Particle Size (DSPS) on the oral PK of AMG 193 in Part 1 (optional substudy, US only). - Part 3
- To evaluate the ORR of AMG 193 in adult subjects with metastatic or locally advanced MTAP-null non-small cell lung cancer NSCLC, after prior treatment with chemotherapy and/or a PD-L1 inhibitor.
- To assess safety and tolerability of AMG 193 in metastatic or locally advanced MTAP-null NSCLC.
- To evaluate DCR, DoR, TTR, duration of SD, PFS, and OS of AMG 193 in metastatic or locally advance MTAP-null NSCLC.
(ACT039)
A Phase 1, Open-label, Dose-escalation and Dose-expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3S-001 Monotherapy in Subjects with Advanced Solid Tumors with a KRAS p.G12C Mutation
Chair:
Dr. Herbert Loong
Eligibility:
• Histologically or cytologically confirmed metastatic or locally advanced solid tumor which is progressing.• ECOG performance status of 0 – 1
• Measurable disease per RECIST v1.1
• Documented KRAS p.G12C mutation identified within the last 5 years by a local test on tumor tissue or blood
• Have received at least 1 line of prior SOC systemic therapy for locally advanced and unresectable or metastatic disease.
• NSCLC (Cohorts 2a and 2b), CRC (Cohort 2c-1), Pancreatic cancer (Cohorts 2c-2):
• Must have archived tumor tissue samples or be willing to undergo a pretreatment tumor biopsy prior to first dose of study medication.
Objectives:
• Evaluate the safety and tolerability of D3S 001 in adult subjects with KRAS p.G12C mutant solid tumors• Determine the maximum tolerated dose (MTD), if applicable, and the recommended phase 2 dose (RP2D)
• Characterize the PK of D3S 001 following administration as an oral capsule formulation
• Evaluate the effect of food on the oral pharmacokinetics of D3S 001
• Evaluate tumor response assessed by Response Evaluation Criteria in Solid Tumors (RECIST) +v1.1 of D3S 001 as monotherapy in advanced solid tumors with a KRAS p.G12C mutation
(BRE034)
A Phase 3, multicenter randomized,open-label, active-controlled study of trastuzumab deruxtecan (DS-8201a), ananti-HER2-antibody drug conjugate, versus ado-trastuzumab emtansine (T-DM1) forHER2-positive, unresectable and/or metastatic breast cancer subjects previouslytreated with trastuzumab and taxane
Chair:
Prof. Winnie Yeo
Eligibility:
Patient with pathologically documented breast cancer that is unresectable or metastatic and has confirmed HER2-positive expression and patient must have reasonable hematological and renal and liver function.Objectives:
Primary Objective:- The primary objective is to compare the efficacy of DS-8201a to T-DM1 on PFS.
Secondary Objectives:
- To further compare the efficacy of DS-8201a compared to T-DM1 on: OS, ORR, DoR and Clinical benefit rate.
(BRE038)
A Phase 3 , Randomized , Double-Blind, Placebo-Controlled Study Evaluating The Efficacy and Safety of GDC-0077 Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Patients with PIK3CA- Mutant , Hormone Receptor- Positive, HER 2- negative Locally Advanced or Metastatic Breast cancer
Chair:
Prof. Winnie Yeo
Objectives:
Primary objectives:The primary efficacy objective for this study is to evaluate the efficacy of GDC-0077 plus palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant on the basis of the following endpoint:
Progression-free survival (PFS), defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Secondary objectives:
The secondary efficacy objective for this study is to evaluate the efficacy of GDC-0077 plus palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant on the basis of the following endpoints:
- Objective response rate (ORR), defined as the proportion of patients with a complete response (CR) and/or partial response (PR) on at least two consecutive occasions ≥4 weeks apart, as determined by the investigator according to RECIST v1.1
- Best overall response rate (BOR), defined as the proportion of patients with a CR or PR, as determined by the investigator according to RECIST v1.1
- Duration of response (DOR), defined as the time from the first occurrence of a CR or PR to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1
- Clinical benefit rate (CBR), defined as the proportion of patients with a CR, PR, and/or stable disease (SD) for at least 24 weeks, as determined by the investigator according to RECIST v1.1
- Overall survival (OS), defined as the time from randomization to death from any cause
(BRE039)
A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in Subjects with High-Risk HER2-Positive Primary Breast Cancer Who Have Residual Invasive Disease in Breast or Axillary Lymph Nodes Following Neoadjuvant Therapy
Chair:
Prof. Winnie Yeo
(BTC004)
A Phase 3, Randomized, Double Blind Study of Pembrolizumab Plus Gemcitabine / Cisplatin versus Placebo Plus Gemcitabine / Cisplatin as First-Line Therapy in Participants with Advanced and/or Unresectable Biliary Tract Carcinoma
Chair:
Prof. Stephen Chan
Eligibility:
Adult patient must have pathologically confirmed advanced (metastatic) and / or unresectable (locally advanced) biliary tract cancer. Patient also needs to have reasonable hematological and renal and liver function.Objectives:
To compare progression-free survival (PFS) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR), between Pembrolizumab plus gemcitabine/cisplatin and placebo plus gemcitabine/cisplatin
(BTC005)
A Phase III Randomized, Double-Blind, Placebo-Controlled,Multi-Regional, International Study of Durvalumab in Combination withGemcitabine plus Cisplatin versus Placebo in Combination with Gemcitabine plusCisplatin for Patients with First-Line Advanced Biliary Tract Cancers (TOPAZ-1)
Chair:
Prof. Stephen Chan
Eligibility:
Adult patient must have histologically confirmed biliary tract cancers without prior systemic therapy. Patient also needs to have reasonable hematological and renal and liver function.Objectives:
To evaluate the efficacy and safety of cabozantinib in combination with nivolumab and ipilimumab versus nivolumab and ipilimumab in previously untreated subjects with intermediate and poor-risk advanced or metastatic RCC
(COL026)
A randomized study ofneoadjuvant chemoradiotherapy with or without intensification with theFOLFOXIRI chemo-regimen for high-risk locally advanced rectal cancer
Chair:
Prof. Brigette Ma
Eligibility:
Histologically proven locally advanced rectaladenocarcinoma without distant metastasis. Patients must not have priortreatment with Oxaliplatin or Irinotecan. Patient should also have adequatehaematologic, renal and hepatic function.Objectives:
Pathologic complete response rate
(COL027)
daNIS-3: An open-label, multi-center, phase II platform study evaluating the efficacy and safety of NIS793 and other new investigational drug combinations with standard of care (SOC) anti-cancer therapy for the second line treatment of metastatic colorectal cancer (mCRC)
Chair:
Prof. Brigette Ma
Eligibility:
Histologically proven metastatic colorectal adenocarcinoma that is not amenable to potentially curative surgery and progressed on or within 6 months after the last dose of one prior line of systemic anti-cancer therapy administered for metastatic disease. Patient should also have adequate haematologic, renal and hepatic function.Objectives:
To confirm the recommended phase 2 dose of each investigational arm in combination with standard of care anti-cancer therapy.
(COL028)
A Randomized Open-Label Phase 3 Study of XL092 + Atezolizumab vs Regorafenib in Subjects with Metastatic Colorectal Cancer
Chair:
Prof. Brigette Ma
Eligibility:
Histologically proven metastatic colorectal cancer patients who have progressed after or are intolerant to standard of care therapy. Patient should also have adequate haematologic, renal and hepatic function.Objectives:
To evaluate the efficacy of XL092 + Atezolizumab versus regorafenib in subjects with RAS wild-type MSS/MSI-low metastatic colorectal cancer patients who have progressed after or are intolerant of standard of care therapy.
(GAT013)
A Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Lenvatinib (E7080/MK-7902) plus Pembrolizumab (MK-3475) plus Chemotherapy Compared with Standard of Care Therapy as First-line Intervention in Participants with dvanced/Metastatic Gastroesophageal Adenocarcinoma (LEAP-015)
Chair:
Prof. Winnie Yeo
Objectives:
Primary Objective:Objective (Part 1): To evaluate the safety and tolerability of treatment with lenvatinib plus pembrolizumab plus chemotherapy.
Objective (Part 2): To compare the overall survival between treatment groups
Hypothesis (H1): Lenvatinib plus pembrolizumab plus chemotherapy is superior to chemotherapy for OS in participants with programmed cell death ligand 1 combined positive score ≥1.
Hypothesis (H4): Lenvatinib plus pembrolizumab plus chemotherapy is superior to chemotherapy for OS in all participants.
Objective (Part 2): To compare the PFS between treatment groups
Hypothesis (H2): Lenvatinib plus pembrolizumab plus chemotherapy is superior to chemotherapy alone for PFS per RECIST 1.1 as assessed by BICR in participants with programmed cell death ligand 1 combined positive score ≥1.
Hypothesis (H5): Lenvatinib plus pembrolizumab plus chemotherapy is superior to chemotherapy for PFS per RECIST 1.1 as assessed by BICR in all participants.
(GAT014)
A Phase 3, multicenter, 2-arm randomized, open-label study of trastuzumab deruxtecan in subjects with HER2-positive metastatic and/or unresectable gastric or gastro-esophageal junction (GEJ) adenocarcinoma subjects who have progressed on or after a trastuzumab-containing regimen (DESTINY-Gastric04)
Chair:
Prof. Winnie Yeo
Objectives:
Primary Objective:To compare OS in HER2-positive (defined as IHC 3+ or IHC 2+/ISH+) GC and GEJ subjects treated with T-DXd vs. Ram + PTX.
Secondary Objectives:
- To compare PFS in HER2-positive GC and GEJ adenocarcinoma subjects treated with T-DXd or Ram + PTX.
- To evaluate further the clinical efficacy of T-DXd and Ram + PTX by ORR based on Investigator assessment
(GYE001)
A Randomised, Multicentre, Double-blind, Placebo-controlled, Phase III Study of First-line Carboplatin and Paclitaxel in Combination with Durvalumab, Followed by Maintenance Durvalumab with or without Olaparib in Patients with Newly Diagnosed Advanced or Recurrent Endometrial Cancer – DUO-E
Chair:
Dr. Ho Wing Ming
Eligibility:
Objectives:
Primary Objectives:To demonstrate the efficacy of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab (Arm B) compared to platinum-based chemotherapy (Arm A) by assessment of progression free survival (PFS), in patients with newly diagnosed advanced or recurrent endometrial cancer
Secondary Objective:
To determine the efficacy of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab in combination with olaparib (Arm C) when compared to platinum based chemotherapy (Arm A) by assessment of PFS in patients with newly diagnosed advanced or recurrent endometrial cancer
To determine the efficacy of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab (Arm B) or durvalumab with olaparib (Arm C) when compared to platinum-based chemotherapy (Arm A) in newly diagnosed advanced or recurrent endometrial cancer patients by assessment of: PFS2, OS, ORR, DoR, TFST, TSST, and TDT
To characterise the PK and immunogenicity of durvalumab and durvalumab in combination with olaparib
To determine effects on symptoms, functioning and overall health-related quality of life (HRQoL) of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab (Arm B) or durvalumab with olaparib (Arm C) when compared to platinum based chemotherapy alone (Arm A) in newly diagnosed advanced or recurrent endometrial cancer patients
Exploratory Objectives:
To determine the efficacy of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab in combination with olaparib (Arm C) when compared to durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab (Arm B) in patients with newly diagnosed advanced or recurrent endometrial cancer
To evaluate additional tumour candidate predictive biomarkers of durvalumab and olaparib in advanced endometrial cancer patientsevaluate tumour predictive biomarkers of durvalumab and olaparib in advanced endometrial cancer patients
To further assess the efficacy of treatment through longitudinal analysis of blood samples collected at regular intervals on study
To explore whether resistance mechanisms to treatment can be identified through analysis of tumour and blood samples – archival tumour sample and blood samples at baseline and on progression (tumour sample optional on progression)
Future exploratory research into factors that may influence development of cancer and/or response to study treatment (where response is defined broadly to include efficacy, tolerability or safety) may be performed on the collected and stored blood or archival tumour samples that were mandatory for entry onto the study or on optional blood or tumour biopsy samples collected during the course of the study
To collect and store DNA (according to each country’s local and ethical procedures) for future exploratory research into genes/genetic variation that may influence response (ie, distribution, safety, tolerability and efficacy) to study treatments and or susceptibility to disease (optional)
To explore health status of patients with durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab with or without olaparib in patients with advanced or recurrent endometrial cancer
To explore patient-reported treatment tolerability with durvalumab in combination with platinum based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab with or without olaparib in patients with advanced or recurrent endometrial cancer
To explore patient-reported severity of cancer symptoms, change in overall health condition, and overall benefit/risk evaluation for durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab with or without olaparib in patients with advanced or recurrent endometrial cancer
To explore healthcare resource associated with durvalumab and olaparib in advanced endometrial cancer patients
Inclusion Crtieria: (PDF file)
Exclusion Criteria: (PDF file)
(HAN015)
A Phase I/II, Open-Label, Multi-Center Study of ALE.C04 (anti-Claudin-1 Antibody) as a Single Agent and in Combination with Pembrolizumab (anti-PD-1 antibody) in Adult Patients with Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma
Chair:
Prof. Brigette Ma
Eligibility:
Histologically proven recurrent or metastatic HNSCC which is incurable by local therapies. Patient should have adequate haematologic, renal and hepatic function.Objectives:
To evaluate safety and tolerability of ALE.C04 as monotherapy and in combination with pembrolizumab.
(HCC055)
A Phase 3, Randomized, Double-blind Study ofAdjuvant Nivolumab versus Placebo for Participants with HepatocellularCarcinoma Who Are at High Risk of Recurrence after Curative Hepatic Resectionor Ablation
Chair:
Prof. Stephen Chan
Eligibility:
Participants must have a first diagnosis of HCC amenable for management with curative intent by resection or local ablation. Participants must have complete resection documented in the pathology report. In addition, patient should have confirmed disease-free status at least 4 weeks after either complete tumor removal after surgical resection or local ablation.Objectives:
Primary Objectives:1. To compare recurrence-free survival (RFS) (based on BICR assessment) of nivolumab vs placebo in all randomized participants.
Secondary Objectives:
1. To compare overall survival (OS) of nivolumab vs placebo in all randomized participants.
2. To evaluate time to recurrence (TTR) (based on BICR assessment) of nivolumab vs placebo in all randomized participants.
(HCC057)
A Phase 3 Double-blinded, Two-arm Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) versus Placebo as Adjuvant Therapy in Participants with Hepatocellular Carcinoma and Complete Radiological Response after Surgical Resection or local Ablation (KEYNOTE-937)
Chair:
Prof. Stephen Chan
Eligibility:
Participants must have a first diagnosis of HCC amenable for management with curative intent by resection or local ablation. Participants must have complete resection documented in the pathology report. In addition, patient should have confirmed disease-free status at least 4 weeks after either complete tumor removal after surgical resection or local ablation.Objectives:
Primary Objectives:1. To compare recurrence-free Survival (RFS).
2. To compare overall survival (OS).
Secondary Objectives:
1. To evaluate the safety and tolerability.
2. To compare time to deterioration (TTD) and score change from baseline in global quality of life using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTCQLQ-C30) global health status/QoL scale and EORTC QLQ-HCC18.
3. To characterize health utilities using the EuroQoL-5 Dimension Questionnaire,5-Level (EQ-5D-5L) healthy utility scores..
(HCC058)
Study on the clinical role of the Albumin-Bilirubin-index (ALBI) in patients treated with lenvatinib for hepatocellular carcinoma
Chair:
Prof. Stephen Chan
Eligibility:
Patient with diagnosis of Hepatocellular Carcinoma who has treated or planned to be treated with Lenvatinib.Objectives:
Primary Objectives:1. To study the prognostication of ALBI on overall survival
Secondary Objectives:
1. To study the serial change of ALBI at baseline, 2-monthand 4-month post treatment
2. To study the association between ALBI and progression-free survival
3. To study the association between ALBI and dose reduction
4. To study the association between ALBI and efficacy
5. To study the association between ALBI and toxicity
6. To study the association between ALBI and pattern of progression
(HCC060)
A PHASE III, MULTICENTER, RANDOMIZED, OPEN-LABELSTUDY OF ATEZOLIZUMAB (ANTI-PD-L1 ANTIBODY) PLUS BEVACIZUMAB VERSUS ACTIVESURVEILLANCE AS ADJUVANT THERAPY IN PATIENTS WITH HEPATOCELLULAR CARCINOMA ATHIGH RISK OF RECURRENCE AFTER SURGICAL RESECTION OR ABLATION
Chair:
Prof. Stephen Chan
Eligibility:
Participants must have a first diagnosis of HCC amenable for management with curative intent by resection or local ablation. Participants must have complete resection documented in the pathology report or have documented evidence of complete radiological response, including disappearance of any intratumoral arterial enhancement in all ablated lesions. In addition, patient should have confirmed disease-free status at least 4 week safter either complete tumor removal after surgical resection or local ablation. Patient is high risk for HCC recurrence after resection or ablation as defined in the protocol.Objectives:
Primary Objectives:1. To evaluate the efficacy of atezolizumab plus bevacizumab compared with active surveillance.
Secondary Objectives:
1. To compare the efficacy of SHR-1210 combined with rivoceranib mesylate versus sorafenib as first-line therapy in subjects with advanced HCC, who have not previously received systemic therapy, through evaluations of PFS, time to progression(TTP), objective response rate (ORR), disease control rate (DCR), and duration of response (DoR)
2. To evaluate the efficacy of atezolizumab plus bevacizumab compared with active
(HCC070)
A Phase 1/2, Safety Confirmation and Double-blind, Placebo-controlled, Randomized Study of Relatlimab in Combination with Nivolumab and Bevacizumab in Treatment-naive Advanced/Metastatic Hepatocellular Carcinoma (RELATIVITY-106)
Chair:
Prof. Stephen Chan
Eligibility:
Adult (≥ 18 years) male and female participants with histologically confirmed HCC and treatment naïve in the advanced/metastatic setting. Patients should have adequate hepatic and renal function.Objectives:
Primary Objectives:- To determine the RP2D of relatlimab, nivolumab, and bevacizumab triplet combination in participants with advanced/metastatic HCC who have not received prior systemic therapy.
- To compare PFS of the relatlimab, nivolumab, and bevacizumab triplet combination to nivolumab and bevacizumab doublet combination in all randomized participants with advanced/metastatic HCC who have not received prior systemic therapy.
Secondary Objectives:
- To estimate key efficacy endpoints of the relatlimab, nivolumab, and bevacizumab triplet combination and the nivolumab and bevacizumab in doublet combination in all randomized participants with advanced/metastatic HCC who have not received prior systemic therapy and all randomized participants who express LAG-3 (≥ 1%) by IHC.
- To determine the safety and tolerability of the relatlimab, nivolumab, and bevacizumab triplet combination in all treated participants with advanced/metastatic HCC who have not received prior systemic therapy.
(HCC072)
Sequential TransArterial chemoembolization and stereotactic RadioTherapy Followed by Durvalumab (MEDI4736) and Tremelimumab for downstaging hepatocellular carcinoma for hepatectomy
Chair:
Prof. Stephen Chan
Eligibility:
Adult (≥ 18 years) participants with histologically or radiologically confirmed unresectable HCC. Tumor size 5-25cm and number of lesions <3. Patients should have adequate hepatic and renal function.Objectives:
Primary Objectives:To assess the objective response rate measured by mRECIST criteria in HCC patients treated with combined TACE and SBRT followed by Durvalumab plus Tremelimumab
Secondary Objectives:
- To assess the number of patients amendable to curative surgical interventions (resection or radiofrequency ablation) after successful down-sizing of tumor(s) by intervention in HCC patients treated with combined TACE and SBRT followed by Durvalumab plus Tremelimumab
- To evaluate the time-to-progression (TTP), progression-free survival (PFS) and overall survival (OS) in HCC patients treated with combined TACE and SBRT followed by Durvalumab plus Tremelimumab
- To measure the toxicities in HCC patients treated with combined TACE and SBRT followed by Durvalumab plus Tremelimumab
- To evaluate the patient-reported quality of life (QoL) treated with combined TACE and SBRT followed by Durvalumab plus Tremelimumab
- To describe the pathological response among HCC patients amendable to surgery after receiving combined TACE and SBRT followed by Durvalumab plus Tremelimumab
- Collection of bio-specimens for future correlative studies in patients treated with TACE and SBRT followed by Durvalumab plus Tremelimumab
(HCC073)
A Phase II, Open-Label, Multi-Drug, Multi-Centre, Master Protocol to Evaluate the Efficacy and Safety of Novel Immunomodulators as Monotherapy and in Combination with Anticancer Agents in Participants with Advanced Hepatobiliary Cancer (GEMINI-Hepatobiliary) Sub-study 1: Hepatocellular Carcinoma (HCC)
Chair:
Prof. Stephen Chan
Eligibility:
Patient with pathological diagnosis of Hepatocellular Carcinoma who has not received prior systemic therapy. Patient should have at least one measurable lesion and adequate hematologic and hepatic function.Objectives:
Primary Objectives:- Investigator RECIST 1.1-based Assessments
- Objective Response Rate
Secondary Objectives:
- Duration of Response
- Disease Control Rate
- Progression-Free Survival
- Overall Survival
Exploratory Objectives:
- To further assess the efficacy of novel immunomodulators alone or in combination with other anticancer drugs in participants with advanced HCC by evaluation of ORR, DoR, DCR, PFS including PFS9 and PFS12 based on BICR assessment
- To assess the preliminary antitumor activity of novel immunomodulators alone or in combination with other anticancer drugs in participants with advanced HCC
(HCC075)
A Phase 1/ 2a, multicenter study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma
Chair:
Prof. Stephen Chan
Eligibility:
Adult (18-70 years of age) participants with histologically confirmed advanced/metastatic HCC and failed or not suitable for standard systemic therapy. Patients should have adequate hepatic and renal function.Objectives:
Phase 1 ObjectivePrimary objectives
- To evaluate the safety and tolerability of SCG101
- To determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) in subjects with hepatitis B virus-related hepatocellular carcinoma
Secondary objectives
- To evaluate the preliminary clinical efficacy of SCG101
- To evaluate the antiviral activity and change in pharmacodynamic markers, such as HBsAg, AST, ALT, and serum tumor markers before and after SCG101 infusion
- To evaluate the persistence (Viral vector copy number, VCN) after SCG101 infusion
Exploratory objectives
- To evaluate the immune profile before and after SCG101 infusion
- To evaluate the persistence (TCR cell count in blood) after SCG101 infusion
- To evaluate the development of an anti-TCR immune response after SCG101 infusion
Phase 2a Objective
Primary objectives
- To evaluate the tumor response of SCG101 in subjects with hepatitis B virus-related hepatocellular carcinoma
Secondary objectives
- To evaluate the safety and tolerability in subjects at RP2D
- To evaluate clinical benefit of SCG101 in subjects with hepatitis B virus-related hepatocellular carcinoma
- To evaluate the antiviral activity and change in pharmacodynamic markers, such as HBsAg, AST, ALT, and serum tumor markers before and after SCG101 infusion
- To continue to evaluate the persistence (viral vector copy number, VCN) after SCG101 infusion.
Exploratory objectives
- To evaluate the immune profile before and after SCG101 infusion
- To evaluate the persistence (TCR cell count in blood) after SCG101 infusion
- To evaluate the development of an anti-TCR immune response after SCG101 infusion
(HCC076)
A Phase IIIb Single Arm, Open-label, Multicentre Study of Durvalumab and Tremelimumab as First Line Treatment in Participants with Advanced Hepatocellular Carcinoma (SIERRA)
Chair:
Prof. Stephen Chan
Eligibility:
The target population of interest in this study is participants ≥ 18 years of age with unresectable HCC, BCLC stage B or stage C, and one of the following must apply:- Child-Pugh score B7 or B8 with a WHO/ECOG PS of 0-1 at enrolment.
- Child-Pugh class A with a WHO/ECOG PS of 2 at enrolment.
- Child-Pugh class A with a WHO/ECOG PS of 0-1 and with evidence of chronic main trunk portal vein thrombosis at enrolment.
Objectives:
Primary objectives:To assess the safety and efficacy of tremelimumab 300 mg × 1 dose therapy plus durvalumab 1500 mg Q4W (STRIDE) in participants with advanced unresectable HCC who have one of the following:
- Child-Pugh score B7 or B8 with a WHO/ECOG PS of 0-1, or
- Child-Pugh class A with a WHO/ECOG PS of 2, or
- Child-Pugh class A with a WHO/ECOG PS of 0-1 and with chronic main trunk portal vein thrombosis
Secondary objectives:
- To further assess the safety and tolerability of STRIDE in participants with advanced unresectable HCC, as described above
- To further assess the efficacy of STRIDE in participants with advanced unresectable HCC,as described above
- To assess disease- and treatment-related symptoms and HRQoL
Exploratory objectives:
- To investigate candidate peripheral and tumoural biomarkers that may correlate with disease, mechanism of action, and clinical benefit of STRIDE
- To investigate ALBI and/or Child-Pugh scores following treatment with STRIDE
(HCC077)
A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING ATEZOLIZUMAB AND BEVACIZUMAB, WITH OR WITHOUT TIRAGOLUMAB, IN PATIENTS WITH UNTREATED LOCALLY ADVANCED OR METASTATIC HEPATOCELLULAR CARCINOMA
Chair:
Prof. Stephen Chan
Eligibility:
Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/cytology or clinically by AASLD criteria in cirrhotic participants. Patient should not receive prior systemic treatment for locally advanced or metastatic and/or unresectable HCC. Patients should have adequate hepatic and renal function.Objectives:
Primary:- To evaluate the efficacy of atezolizumab plus bevacizumab plus tiragolumab compared with atezolizumab plus bevacizumab
Secondary:
- To evaluate the efficacy of atezolizumab plus bevacizumab plus tiragolumab compared with atezolizumab plus bevacizumab
- To evaluate the safety of atezolizumab plus bevacizumab plus tiragolumab compared with atezolizumab plus bevacizumab
- To characterize the PK profile of atezolizumab plus bevacizumab plus tiragolumab
- To evaluate the immune response to tiragolumab and atezolizumab
Exploratory:
- To evaluate the efficacy of atezolizumab plus bevacizumab plus tiragolumab compared with atezolizumab plus bevacizumab
- To evaluate the patient-reported tolerability of atezolizumab plus bevacizumab plus tiragolumab compared with atezolizumab plus bevacizumab from the participant's perspective
- To evaluate potential relationships between drug exposure and the efficacy and safety of atezolizumab plus bevacizumab plus tiragolumab
- To evaluate participant demographics, PK, efficacy, and safety endpoints by atezolizumab and tiragolumab ADA status
- To evaluate health status utility scores of participants treated with atezolizumab plus bevacizumab plus tiragolumab compared with atezolizumab plus bevacizumab
- To identify and/or evaluate biomarkers that are predictive of response to atezolizumab plus bevacizumab plus tiragolumab (i.e., predictive biomarkers), are early surrogates of efficacy, are associated with progression to a more severe disease state (i.e., prognostic biomarkers), are associated with acquired resistance to atezolizumab plus bevacizumab plus tiragolumab, can provide evidence of atezolizumab plus bevacizumab plus tiragolumab activity (i.e., pharmacodynamic biomarkers), or can increase the knowledge and understanding of disease biology and drug safety or pharmacokinetics
(LUN087)
A phase 1b, open label, multi-center study to characterize the safety, tolerability and preliminary efficacy of EGF816 in combination with selected targeted agents in EGFR mutant NCLC
Chair:
Dr. Herbert Loong
Eligibility:
Patient must have EGFR-mutation, locally advanced or metastatic disease. Patient must have reasonable hematological, liver and renal functionObjectives:
To characterize the safety and tolerability of EGF816 in combination with ribociclib, trametinib, or LXH254 in patients with advanced EGFR-mutant NSCLC
(LUN094)
A single-arm, open-label, phase 2 study of dacomitinib with or without dose titration for the first-line treatment of locally advanced or metastatic non-small cell lung cancer in subjects with an epidermal growth factor receptor (EGFR) activation mutation
Chair:
Prof. Tony Mok, BBS
Eligibility:
Inclusion & Exclusion Criteria: (PDF file)Objectives:
Primary Objectives:To demonstrate that dacomitinib treatment with or without dose titration is superior to historical control with respect to PFS rate at 12 mths (investigators’ assessment)
94 subjects required to achieve a one-sided significance level of 5% and 90% power to detect a 15% improvement in 12 mth PFS rate for dacomitinib versus historical control for gefitinib
Secondary Objective:
To compare secondary measures of efficacy: OS, objective response rate (ORR), time to treatment failure (TTF), intracranial objective response rate (iORR) and intracranial PFS
To evaluate the safety and tolerability of dose titration according to toxicity
Exploratory Objectives:
To determine resistance mechanism(s) associated with disease progression on dacomitinib
To further evaluate intracranial efficacy of dacomitinibby determining site(s) of progression
(LUN095)
A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF TIRAGOLUMAB IN COMBINATION WITH ATEZOLIZUMAB PLUS PEMETREXED AND CARBOPLATIN/CISPLATIN VERSUS PEMBROLIZUMAB PLUS PEMETREXED AND CARBOPLATIN/CISPLATIN IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED NON-SQUAMOUS NON-SMALL CELL LUNG CANCER
Chair:
Prof. Tony Mok, BBS
Objectives:
Primary Objectives:To evaluate the efficacy of tiragolumab in combination with atezolizumab plus pemetrexed and carboplatin/cisplatin (Arm A) compared with placebo in combination with pembrolizumab plus pemetrexed and carboplatin/cisplatin (Arm B)
Secondary Objectives:
To evaluate the efficacy of tiragolumab in combination with atezolizumab plus pemetrexed and carboplatin/cisplatin (Arm A) compared with placebo in combination with pembrolizumab plus pemetrexed and carboplatin/cisplatin (Arm B)
Safety Objective:
To evaluate the safety of tiragolumab in combination with atezolizumab plus pemetrexed and carboplatin/cisplatin (Arm A) compared with placebo in combination with pembrolizumab plus pemetrexed and carboplatin/cisplatin (Arm B)
Immunogenicity (PK) Objective:
To characterize the pharmacokinetics of tiragolumab and atezolizumab
Exploratory immunogenicity Objective:
To evaluate potential effects of anti-drug antibodies (ADAs)
Exploratory biomarker Objective:
To identify and/or evaluate biomarkers that are predictive of response to tiragolumab and atezolizumab (i.e., predictive biomarkers), are early surrogates of efficacy, are associated with progression to a more severe disease state (i.e., prognostic biomarkers), are associated with acquired resistance to tiragolumab and atezolizumab, are associated with susceptibility to developing adverse events or can lead to improved adverse event monitoring or investigation (i.e., safety biomarkers), can provide evidence of tiragolumab and atezolizumab, activity (i.e., PD biomarkers), or can increase the knowledge and understanding of disease biology and drug safety
(LUN096)
LIBRETTO-431: A Multicenter, Randomized, Open-Label, Phase 3 Trial Comparing LOXO-292 To Platinum-Based and Pemetrexed Therapy with or without Pembrolizumab as Initial Treatment of Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer
Chair:
Dr. Herbert Loong
Eligibility:
Adult patients with locally advanced or metastatic, RET fusion-positive non-squamous non-small cell lung cancer (NSCLC) who have NOT received any prior systemic therapy (chemotherapy, immunotherapy, or biological therapy), willing to undergo a tumor biopsy at screening if medically feasible.Objectives:
To compare the efficacy of selpercatinib with the combination of platinum-based (carboplatin or cisplatin) and pemetrexed therapy, with or without pembrolizumab, in patients with advanced or metastatic RET fusion-positive NSCLC
(LUN099)
A Randomized Phase 3 Study of MRTX849 versus Docetaxel in Patients with Previously Treated Non-Small Cell Lung Cancer with KRAS G12C Mutation (KRYSTAL-12)
Chair:
Prof. Tony Mok, BBS
Objectives:
Primary Objectives:To compare the efficacy of MRTX849 versus docetaxel in patients with NSCLC with KRAS G12C mutation and who have received prior treatment with a platinum-based regimen and immune checkpoint inhibitor therapy.
Secondary Objectives:
To evaluate the safety and tolerability in the study population.
To evaluate secondary efficacy endpoints in the study population.
To evaluate the pharmacokinetics (PK) of MRTX849 administered in the study population.
To evaluate health-related quality of life (HRQOL) and lung cancer‑specific symptoms in the study population.
Efficacy endpoints:
Objective Response Rate (ORR)
Duration of Response (DOR)
1-Year Survival Rate
(LUN100)
An Open-Label, Multicenter, Phase 2 study of Sacitizumab Govitecan Combinations in First Line Treatment of Patients with Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Without Actionable Genomic Alterations
Chair:
Prof. Tony Mok, BBS
Objectives:
Primary Objectives:To assess the objective response rate (ORR) of sacituzumab govitecan (SG) in combination with pembrolizumab or pembrolizumab + a platinum agent.
Determine the recommended Phase 2 dose (RP2D) of SG in combination with pembrolizumab + a platinum agent.
Secondary Objectives:
To assess the effect of SG in combination with pembrolizumab or pembrolizumab + a platinum agent on the following:
• Progression-free survival (PFS) as assessed by IRC per RECIST Version 1.1.
• Overall survival (OS).
• Duration of response (DOR) as assessed by IRC per RECIST Version 1.1.
• Disease control rate (DCR) as assessed by IRC per RECIST Version 1.1.
• Safety and tolerability.
(LUN101)
KontRASt-02:A randomized, controlled, open label, phase III study evaluating the efficacy and safety of JDQ443 versus docetaxel in previously treated subjects with locally advanced or metastatic KRAS G12C mutant non-small cell lung cancer (Novartis)
Chair:
Dr. Herbert Loong
Eligibility:
Key Inclusion Criteria:- Participants are male and female, aged 18 or older.
- Histologically confirmed locally advanced stage IIIB/IIIC (and not eligible for definitive chemo-radiation curative therapy or complete surgical resection) or stage IV previously treated NSCLC. Presence of a KRAS G12C mutation by central laboratory testing using tissue samples.
- Participants have received one prior platinum-based chemotherapy and one prior immune checkpoint inhibitor therapy either in combination or in sequence.
- Participants with ECOG performance status from 0 to 2.
Key Exclusion Criteria:
- Participants who have previously received docetaxel, KRAS G12C inhibitor, or any other systemic therapy for their locally advanced or metastatic NSCLC other than one platinum-based chemotherapy and one prior immune checkpoint inhibitor therapy.
- Participants with epidermal growth factor receptor (EGFR)-sensitizing mutation and/or anaplastic lymphoma kinase (ALK) rearrangement by local testing.
- Participants with other known druggable alterations will be excluded, if required by local guidelines.
- History of severe hypersensitivity reaction to taxanes or any excipients of these study treatments.
Objectives:
Primary Objectives:To compare overall survival (OS) in the two treatment arms
Secondary Objectives:
- To assess the anti-tumor activity of JDQ443 compared to docetaxel
- To assess PFS2 in the two treatment arms
- To characterize the safety profile of JDQ443
- To assess the effect of JDQ443 vs docetaxel on PROS (NSCLC-SAQ, EORTC QLQ-C30, lung specific module QLQ-LC13 and EQ-5D-5L) including lung cancer symptoms, health-related quality of life and health status
- To characterize the pharmacokinetics of JDQ443.
- To assess the effect of JDQ443 vs docetaxel on ECOG performance status.
- To assess the safety of JDQ443 in participants who crossover from docetaxel.
Exploratory Objectives:
- To assess genetic alterations in cancer-related genes in tumor and/or plasma samples and to evaluate their relationship to clinical outcomes
- To assess blood-based biomarkers as predictive markers for clinical response and/or safety
- To assess potential mechanisms of resistance to JDQ443 therapy
- To explore the association of baseline immune biomarkers as well as changes in markers of the immune microenvironment in the tumor between baseline and post baseline samples and clinical outcome
- To assess the relationship between PK of JDQ443 and pharmacodynamic (PD) biomarkers safety and efficacy
(LUN102)
Herthena-Lung02 -A Phase 3, Randomized, Open‑label Study of Patritumab Deruxtecan Versus Platinum based Chemotherapy in Metastatic or Locally Advanced Epidermal Growth Factor Receptor-mutated (EGFRm) Non‑small Cell Lung Cancer (NSCLC) After Failure of Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) Therapy
Chair:
Prof. Tony Mok, BBS
Eligibility:
Objectives:
Primary Objectives:To compare the efficacy of patritumab deruxtecan versus platinum-based chemotherapy, as measured by PFS, in subjects with metastatic or locally advanced nonsquamous NSCLC with an EGFR-activating mutation (exon 19 deletion or L858R)
Secondary Objectives:
To compare the efficacy of patritumab deruxtecan versus platinum-based chemotherapy, as measured by OS, in subjects with metastatic or locally advanced nonsquamous NSCLC with an EGFR-activating mutation (exon 19 deletion or L858R)
PFS as assessed by the Investigator
PFS as assessed by local standard clinical practice
ORR, DoR, CBR, DCR and TRR as assessed by BICR and as assessed by the Investigator
PRO as assessed by NSCLC-SAQ, 5 functioning scales, global health status, and overall quality of life assessed by EORTC QLQ-C30
Safety as graded by NCI CTCAE v5.0
HER3 protein expression in tumor tissue and its relationship with efficacy Immunogenicity
Exploratory Objectives:
Further evaluate PRO endpoints for subjects treated with patritumab deruxtecan compared with those with platinum-based chemotherapy
Further characterize the PK of patritumab deruxtecan
Population PK modeling
Inclusion Criteria: (PDF file)
Exclusion Criteria: (PDF file)
(LUN104)
A Randomized, Open-Label, Phase 3 Study to Evaluate Zimberelimab and Domvanalimab in Combination with Chemotherapy Versus Pembrolizumab with Chemotherapy for the First-Line Treatment of Patients With Metastatic Non–Small Cell Lung Cancer With No Epidermal Growth Factor Receptor or Anaplastic Lymphoma Kinase Genomic Tumor Aberrations (Star 121)
Chair:
Dr. Molly Li
Eligibility:
Objectives:
Primary Objectives:To compare the effect of ZIM and DOM plus Chemo with chemotherapy relative to PEMBRO plus Chemo (Group A versus Group B) on:
- Progression-free survival (PFS) according to RECIST v1.1 as assessed by blinded independent central review (BICR)
- Overall survival (OS)
Secondary Objectives:
- To compare the effect of ZIM and DOM plus Chemo relative to PEMBRO plus Chemo (Group A versus Group B) on objective response rate (ORR) as assessed by BICR according to RECIST v1.1
- To evaluate duration of response (DOR) as assessed by BICR according to the RECIST v1.1
- To evaluate the safety and tolerability of ZIM and DOM in combination with chemotherapy versus PEMBRO in combination with chemotherapy (Group A versus Group B
- To compare the effect of ZIM and DOM in combination with chemotherapy relative to PEMBRO in combination with chemotherapy (Group A versus Group B) on health-related quality of life (QOL) using NSCLC-SAQ.
Inclusion Criteria: (PDF file)
Exclusion Criteria: (PDF file)
(LUN107)
A Randomized Phase 3 Study of Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab, with or Without Platinum Chemotherapy, in Subjects with No Prior Therapy for Advanced or Metastatic PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung07)
Chair:
Dr. Herbert Loong
Eligibility:
- Adults ≥18 at the time the Main ICF is signed.
- Tumor has PD-L1 TPS <50% as determined by PD-L1 IHC 22C3 pharmDx assay by central testing.
- Has provided a formalin-fixed tumor tissue sample for the measurement of TROP2 protein expression and for the assessment of other exploratory biomarkers.
- Has not been treated with systemic anticancer therapy for advanced or metastatic non-squamous NSCLC.
- Has measurable disease based on local imaging assessment using RECIST v1.1; radiographic tumor assessment must be performed within 28 days of randomization.
- Histologically documented NSCLC that meets all of the following criteria:
- Has Stage IIIB or IIIC disease who is not a candidate for surgical resection or definitive chemoradiation, or Stage IV non-squamous NSCLC disease at the time of randomization (based on the American Joint Committee on Cancer, Eighth Edition26).
- Has documented negative test results for EGFR, ALK, and ROS1 actionable genomic alterations based on analysis of tumor tissue.
- Has no known actionable genomic alterations in NTRK, BRAF, RET, MET, or other actionable driver kinases with locally approved therapies. Subjects with tumors that harbor KRAS mutations are eligible for this study.
- Has an ECOG performance status of 0 or 1 at screening
Objectives:
- To compare the efficacy of Dato-DXd in combination with pembrolizumab with or without platinum-based chemotherapy versus pembrolizumab plus pemetrexed and platinum-based chemotherapy, as measured by Progression-Free Survival (PFS) by blinded independent central review (BICR), Overall Survival (OS) and objective response rate (ORR).
- To further evaluate the efficacy of Dato-DXd in combination with pembrolizumab with or without platinum-based chemotherapy versus pembrolizumab plus platinum- pemetrexed chemotherapy
- To evaluate the patient-reported outcomes (PROs) of Dato-DXd in combination with pembrolizumab with or without platinum-based chemotherapy versus pembrolizumab plus platinum-pemetrexed chemotherapy
- To further evaluate the safety of Dato-DXd in combination with pembrolizumab with or without platinum-based chemotherapy versus pembrolizumab plus platinum- pemetrexed chemotherapy
- To assess the immunogenicity of Dato-DXd in combination with pembrolizumab with or without platinum-based chemotherapy
(LUN108)
A Randomized, Open-label, Phase 3 Trial of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in Treatment naïve Subjects with Advanced or Metastatic PD L1 High (TPS ≥50%) Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung08)
Chair:
Dr. Herbert Loong
Eligibility:
- Adults ≥18 at the time the Main ICF is signed.
- Histologically documented NSCLC that meets all of the following criteria:
- Has Stage IIIB or IIIC disease who is not a candidate for surgical resection or definitive chemoradiation, or Stage IV non-squamous NSCLC disease at the time of randomization (based on the American Joint Committee on Cancer, Eighth Edition26).
- Has documented negative test results for EGFR, ALK, and ROS1 actionable genomic alterations based on analysis of tumor tissue.
- Has no known actionable genomic alterations in NTRK, BRAF, RET, MET, or other actionable driver kinases with locally approved therapies. Subjects with tumors that harbor KRAS mutations are eligible for this study.
- Has provided a formalin-fixed tumor tissue sample (minimum of 4 × 4 micron sections or block equivalent) for the measurement of TROP2 protein expression and for the assessment of other exploratory biomarkers.
- Tumor has high PD-L1 expression (TPS ≥50%) as determined by PD-L1 IHC 22C3 pharmDx assay by central testing (minimum of 6 slides).
- Has measurable disease based on local imaging assessment using RECIST Version 1.1
- Has an ECOG performance status of 0 or 1 at screening
- Has not received prior systemic treatment for advanced or metastatic NSCLC
Objectives:
- To compare the efficacy of Dato-DXd in combination with pembrolizumab versus pembrolizumab alone in terms of either PFS by BICR or OS in treatment-naïve subjects with high PD-L1 expression and advanced or metastatic NSCLC without actionable genomic alterations
- To compare the efficacy of Dato-DXd in combination with pembrolizumab versus pembrolizumab alone in terms of ORR by BICR
(NPC033)
AXEL: Axitinib-Avelumab combination in recurrent or metastatic nasopharyngeal cancer: a multicenter phase 2 trial
Chair:
Prof. Anthony Chan
Eligibility:
Adult patient must have histologically confirmed nasopharyngeal carcinoma with recurrent or metastatic disease. Patient must have adequate hematological, liver and renal function.Objectives:
To determine the overall response rate of using Avelumab with Axitinib for patients with recurrent or metastatic nasopharyngeal carcinoma following platinum-based chemotherapy by RECIST criteria version 1.1.
(NPC036)
An Open-Label, Multicenter Phase 1b/2 Study of Nanatinostat and Valganciclovir in Patients with Advanced Epstein-Barr Virus-Positive (EBV+) Solid Tumors and in Combination with Pembrolizumab in Patients with Recurrent/Metastatic Nasopharyngeal Carcinoma
Chair:
Prof. Brigette Ma
Eligibility:
Adult patients with recurrent or metastatic nasopharyngeal carcinoma (RM-NPC), who have received at least prior line of platinum-based chemotherapy and no more than 3 prior lines of therapy, must have histologically or cytologically documented EBV+ tumor cells by EBER-ISH or LMP-1 per archival sample taken within 2 years prior to screening. Patients with EBV+ non-NPC solid tumors (gastric cancer, lymphoepithelioma, leiomyosarcoma) that have progressed despite standard therapy for which no curative therapies exist could be eligible for phase 1b only.Objectives:
To evaluate the efficacy and safety of nanatinostat and valganciclovir alone and in combination with pembrolizumab
(NPC037)
A phase 2 trial of TAS 102 in recurrent/metastatic nasopharyngeal carcinoma
Chair:
Prof. Brigette Ma
Eligibility:
Adult patient must have histologically confirmed nasopharyngeal carcinoma with recurrent or metastatic disease with prior treatment. Patient must have adequate hematological, liver and renal function.Objectives:
To determine the clinical efficacy of TAS-102 in recurrent and metastatic NPC.
(PST008)
Randomized phase II study of combination androgen deprivation therapy (ADT) and radiotherapy in high risk prostate cancer: Stereotactic body Radiotherapy vs conventionAl IMRT to prostate and pelvic nodes (SRAM study)
Chair:
Dr. Darren Poon
Eligibility:
Patient ≥ 18 years old must have histological confirmation of high risk prostate adenocarcinoma. Patient must not have prior chemotherapy, prostatectomy, cryosurgery or HIFU for prostate cancer.
Objectives:
To compare acute toxicities between SBRT versus conventional IMRT.
(SYM012)
A pilot randomized open-labeled study comparing a structured titration method of immediate- and sustained-release oxycodone versus titration of investigators’ choice inadvanced cancer patients in Hong Kong
Chair:
Dr. Herbert Loong
Eligibility:
Patientmust have moderate to severe cancer pain, able to take oral drugs and withreasonable liver and renal function.Objectives:
To compare efficacy of the structured titrationmethod with predefined titration steps with the use of oxycodoneimmediated-release and oxycodone sustained-release preparations to standard practice.
(TGC001)
A Phase 3, Randomized, Placebo-controlled, Double-blind Study of Vimseltinib to Assess the Efficacy and Safety in Patients with Tenosynovial Giant Cell Tumor (MOTION)
Chair:
Dr. Herbert Loong
Eligibility:
Symptomatic patients with histologically confirmed TGCT for whom surgical resection will potentially cause worsening functional limitation or severe morbidity will be eligible. Patients who received anti-CSF1/CSF1R therapy previously (except for imatinib or nilotinib) will be excluded..Inclusion Criteria (PDF):
Exclusion Criteria (PDF):
Objectives:
Primary Objectives:To evaluate anti-tumor activity of vimseltinib using RECIST v1.1 by blinded independent
Secondary Objectives:
• To assess anti-tumor activity of vimseltinib using tumor volume score (TVS) and modified RECIST (mRECIST) by blinded independent radiological review
• To assess the effects of vimseltinib on range of motion (ROM)
• To assess the effects of vimseltinib on physical function, worst stiffness, worst pain, and quality of life (QoL) using patient-reported outcome (PRO) measures
• To assess safety and tolerability of vimseltinib
Exploratory Objectives:
• To assess the correlation of pharmacokinetics (PK) with efficacy and/or safety
• To assess the pharmacodynamic effects of vimseltinib in relation to safety or efficacy
• To assess germline polymorphic variations in genes involved in the metabolism or disposition of vimseltinib or in relation to safety or efficacy.
• To assess long-term safety and efficacy of vimseltinib.
• To assess the effects of vimseltinib on symptomatic relief and functional assessments
(TRA016)
The Immunological Mechanism of Plasma EBV DNA Clearance during Radiotherapy in Patients with Nasopharyngeal Carcinoma-a pilot study
Chair:
Prof. Brigette Ma