Clinical Trials
(ACT011)
A Phase 1/2 Study of Oral Selpercatinib (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.
(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.
(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 pembrolizumab 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.
(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 1/2, Open-label, Dose-escalation, and Dose-expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3S-001 Monotherapy or Combination Therapy 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
(ACT041)
A Phase 1b/2, Open-Label, Dose Escalation and Expansion Study of ADG126 in Combination with Pembrolizumab (Anti-PD-1 Antibody) in Patients with Advanced/Metastatic Solid Tumors
Chair:
Prof. Brigette Ma
Eligibility:
Adult patient must have histologically metastatic solid tumors. Patient must have adequate hematological, liver and renal function.Objectives:
To assess the preliminary antitumor activity of ADG126-pembrolizumab combination regimen.
(ACT043)
A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-022, an anti-TIM-3 Monoclonal Antibody, in Patients with Advanced Solid Tumors (AMBER)
Chair:
Prof. Stephen Chan
Eligibility:
(Cohort 2F only) Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/cytology. Patient should not receive prior systemic treatment for HCC and has adequate hepatic and renal function.Objectives:
Primary:- To evaluate the anti-tumor activity of TSR-022 in combination with TSR-042 in patients with solid tumors, in terms of ORR as assessed by the Investigators using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Secondary:
- To evaluate the safety and tolerability of cobolimab + dostarlimab in HCC
- Overall survival (OS) for patients
- Alpha-fetoprotein (AFP) response
Exploratory:
- To characterize the PK of Cobolimab and Dostarlimab
- To evaluate the immunogenicity of Cobolimab and Dostarlimab in Part 2F
- To characterize the Pharmacodynamic profile of TSR-022 and
- in combination therapy with TSR-042
- To explore changes in biomarkers (e.g., immune cells and immune proteins) in the tumor and circulating biomarkers in the blood following treatment with TSR-022 and correlate with clinical benefit
- To further evaluate additional measures of clinical benefit including:
- ORR by irRECIST
- DOR by irRECIST
- DCR by irRECIST
- PFS by irRECIST
- ORR by RECIST v1.1 in comparison to patients in Sorafenib ECA
(ACT045)
A Phase 2 Nonrandomized, Open-label, Multisite Study to Evaluate the Safety and Efficacy of Raludotatug Deruxtecan in Participants with Gastrointestinal Cancers
Chair:
Prof. Brigette Ma
Eligibility:
Adult patient must have histologically confirmed locally advanced, unresectable or metastatic carcinoma. Patient must have adequate hematological, liver and renal function.Objectives:
To evaluate the confirmed ORR per RECIST 1.1 as assessed by BICR.
(ACT046)
A Phase I/II, Open-Label, Multicenter Study of ALE.P02 (Claudin-1 Targeted Antibody-Drug Conjugate) as a Monotherapy in Adult Patients with Selected Advanced or Metastatic CLDN1+ Squamous Solid Tumors
Chair:
Prof. Brigette Ma
Eligibility:
Adult patient must have histologically confirmed locally advanced, unresectable or metastatic squamous cell carcinoma. Patient must have adequate hematological, liver and renal function.Objectives:
To evaluate the safety and tolerability of study drug
(ACT048)
A Phase I/II, Open-label, Multicenter Study of ALE.P03 (Claudin-1 Targeted Antibody-drug Conjugate) as a Monotherapy in Adult Patients with Selected Advanced or Metastatic CLDN1+ Solid Tumors
Chair:
Prof. Stephen Chan
Eligibility:
Patient with selected Advanced or Metastatic CLDN1+ solid tumors (CRC, iCCA, sqNSCLC, UC, or CSCC)Objectives:
Primary objectives:- (Phase I dose escalation) To evaluate the safety and tolerability of ALE.P03
- (Phase I RDE) To establish the RP2D for ALE.P03
- (Phase II) To assess the anti-tumor activity of ALE.P03
Secondary Objectives:
- (Phase I RDE and Phase II) To evaluate the safety and tolerability of ALE.P03 Preliminary evidence of the anti-tumor activity of ALE.P03 (Phase I and II)
- (Phase I and II) To assess the PK profile of ALE.P03 (total antibody, conjugated exatecan, and free payload exatecan)
- (Phase I and II) To evaluate the immunogenicity of ALE.P03
Exploratory objective:
- (Phase I) To evaluate biomarkers associated with ALE.P03’s mode of action in blood and tumor
- (Phase I and II) To investigate PK and PD biomarkers for association with safety and efficacy measurements
- (Phase I and II) To investigate the dose-response relationships of ALE.P03 with safety and efficacy endpoints
- (Phase I and II) To evaluate the impact of ADA on PK, PD, efficacy, and safety, as supported by available data
(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
(BRE045)
A Phase 3, Randomized, Multi-center, Open-label Study of DB-1303 Versus Investigator’s Choice Chemotherapy in Human Epidermal Growth Factor Receptor 2 (HER2)-low, Hormone Receptor Positive (HR+) Metastatic Breast Cancer Patients whose Disease has Progressed on Endocrine Therapy (ET) (DYNASTY-Breast02)
Chair:
Prof. Winnie Yeo
(BRE046)
An Open-label, Randomized Phase 3 Study of MK-2870 as a Single Agent and in Combination with Pembrolizumab Versus Treatment of Physician’s Choice in Participants with HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer
Chair:
Prof. Winnie Yeo
Eligibility:
Key Inclusion Criteria:Either one of the following:
- Radiographic disease progression on one or more lines of endocrine therapy with one in combination with a CDK4/6 inhibitor
- Radiographic disease progression within 6 months of starting 1L endocrine therapy in combination with a CDK4/6 inhibitor that was prematurely discontinued (before experiencing radiologic disease progression due to intolerance)
- Radiographic disease progression >/= 6 months of starting 1L endocrine treatment in combination with a CDK4/6 inhibitor that was prematurely discontinued (before experiencing radiologic disease progression due to intolerance) AND Radiographic disease progression on an additional (2nd) endocrine therapy
- Relapsed during, or within 12 months of completing adjuvant endocrine therapy with a CDK4/6 inhibitor
- For ER-low positive tumor (ER 1-10%): previous therapy with CDK4/6 inhibitors and/or Endocrine Therapy is permitted but not required.
Key Exclusion Criteria:
- Has breast cancer amenable to treatment with curative intent
- Has experienced an early recurrence (<6 months after completing adjuvant therapy) and therefore is eligible to receive second line treatment
- Has a known ESR1 mutation and has not received previous treatment with elacestrant (where available and not medically contraindicated)
- Has a known germline BRCA mutation (deleterious or suspected deleterious) and has not received previous treatment with PARP inhibition either in the adjuvant or metastatic setting (where available and not medically contraindicated)
- Has Grade ≥2 peripheral neuropathy
- Has received prior chemotherapy for unresectable locally advanced or MBC
- Requires treatment with a strong inhibitor or inducer of CYP3A4 at least 14 days before the first dose of study intervention and throughout the study
- Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization. Note: Participants previously treated with endocrine therapy plus a targeted agent (e.g., mTOR or PI3K or CDK4/6 inhibitors) may participate as long as at least 2 weeks have elapsed since the last dose of therapy was administered
Objectives:
Primary objective:To compare
- MK-2870 to TPC
- MK-2870 plus pembrolizumab to TPC with respect to PFS per RECIST 1.1 as assessed by BICR in all participants
Secondary objective:
To compare
- MK-2870 to TPC
- MK-2870 plus pembrolizumab to TPC
- MK-2870 plus pembrolizumab to MK-2870 with respect to OS in all participants
(BTC008)
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Global Study of Rilvegostomig in Combination With Chemotherapy as Adjuvant Treatment After Resection of Biliary Tract Cancer With Curative Intent (ARTEMIDE-Biliary01)
Chair:
Prof. Stephen Chan
Eligibility:
Histologically confirmed adenocarcinoma of the biliary tract (intrahepatic or extrahepatic CCA or muscle invasive GBC) who have undergone macroscopically complete resection with curative intent (R0 or R1) within 12 weeks of randomization. Patient should not receive prior systemic treatment. Patients should have adequate hepatic and renal function.Objectives:
Primary:- To demonstrate superiority of rilvegostomig + chemotherapy relative to placebo + chemotherapy by assessment of RFS in participants with BTC after resection with curative intent
Secondary:
- To demonstrate superiority of rilvegostomig in combination with chemotherapy relative to placebo in combination with chemotherapy by assessment of OS in participants with BTC after resection with curative intent
- To assess patient-reported tolerability (overall bother, physical functioning, symptoms) in participants with BTC after resection with curative intent treated with rilvegostomig in combination with chemotherapy compared to placebo in combination with chemotherapy
- To assess the efficacy of rilvegostomig in combination with chemotherapy compared to placebo in combination with chemotherapy by PD-L1 expression in participants with BTC after resection with curative intent
- To assess the efficacy of rilvegostomig + chemotherapy compared to placebo + chemotherapy by assessment of PFS following recurrence in participants with BTC after resection with curative intent
- To assess the PK of rilvegostomig when used in combination with chemotherapy in participants with BTC after resection with curative intent
- To investigate the immunogenicity of rilvegostomig in participants with BTC after resection with curative intent
Exploratory:
- To collect and assess blood and tumor samples for biomarker analysis in participants with BTC after resection with curative intent treated with rilvegostomig or placebo in combination with chemotherapy
- To investigate the relationship between circulating factors and efficacy outcomes
- To assess maintenance of physical functioning, role functioning, and HRQoL
- To assess maintenance of physical functioning assessed via CAT
- To explore the impact of treatment and disease state on health state utility using the EQ-5D-5L
- To explore the impact of treatment and disease on health care resource use
(BTC011)
DESTINY-Biliary Tract Cancer-01: A Phase 3 Study of Trastuzumab Deruxtecan (T-DXd) and Rilvegostomig versus Standard-of-Care Gemcitabine, Cisplatin, and Durvalumab for First Line Locally Advanced or Metastatic HER2-expressing Biliary Tract Cancer
Chair:
Prof. Stephen Chan
Eligibility:
Unresectable, previously untreated, locally advanced or metastatic biliary tract adenocarcinoma. Histologically confirmed HER2-expressing (IHC 3+ or IHC 2+). Patients should have adequate hepatic and renal function.Objectives:
Primary:- To evaluate the efficacy of T-DXd with rilvegostomig vs SoC in terms of OS in the FAS (HER2 IHC 3+) population
Secondary:
- To evaluate the efficacy of T-DXd with rilvegostomig vs SoC in terms of OS in the FAS (HER2 IHC 3+/2+) population
- To evaluate the efficacy of T-DXd monotherapy vs SoC in terms of OS in the FAS (HER2 IHC 3+) population
- To evaluate the efficacy of T-DXd monotherapy vs SoC in terms of OS in the FAS population
(COL030)
A Randomized, Open-label Phase 3 Study of Amivantamab + FOLFIRI Versus Cetuximab/Bevacizumab + FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Recurrent, Unresectable or Metastatic Colorectal Cancer Who Have Received Prior Chemotherapy
Chair:
Prof. Brigette Ma
Eligibility:
Adult patient must have histologically confirmed adenocarcinoma with recurrent, unresectable or metastatic disease. Patient must have adequate hematological, liver and renal function.Objectives:
To determine if amivantamab + FOLFIRI will demonstrate superior PFS or OS compared with cetuximab or bevacizumab + FOLFIRI as second-line treatment in adult participants with KRAS/NRAS and BRAF WT recurrent, unresectable or metastatic colorectal cancer who have received prior chemotherapy.
(COL031)
A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084, Cetuximab, and mFOLFOX6 versus mFOLFOX6 With or Without Bevacizumab as First-line Treatment of Participants With KRAS G12C-mutant, Locally Advanced Unresectable or Metastatic Colorectal Cancer (KANDLELIT-012)
Chair:
Prof. Brigette Ma
Eligibility:
Adult patient must have treatment-naïve KRAS G12C mutant locally advanced unresectable or metastatic disease. Patient must have adequate hematological, liver and renal function.Objectives:
To evaluate the safety and tolerability of treatment with MK-1084, Cetuximab and m-FOLFOX6
(GAT017)
A Phase 3, Multicenter, Open-label, Randomized Study to Compare the Efficacy and Safety of MK-2870 Versus Treatment of Physician’s Choice in 3L+ Advanced/Metastatic Gastroesophageal Adenocarcinoma (Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, and Esophageal Adenocarcinoma)
Chair:
Prof. Winnie Yeo
Objectives:
Primary objective:- To compare MK-2870 to TPC with respect to OS
Secondary objectives:
- To compare MK-2870 to TPC with respect to PFS per RECIST 1.1 as assessed by BICR
- To compare MK-2870 to TPC with respect to OR per RECIST 1.1 as assessed by BICR
- To compare MK-2870 to TPC with respect to DOR per RECIST 1.1 as assessed by BICR in participants who demonstrate confirmed CR or PR during or after treatment with study intervention
- To evaluate the safety and tolerability of MK-2870
(GIS001)
(Peak) A Phase 3 Randomized, Open-label, Multicenter Clinical Study of CGT9486+Sunitinib vs Sunitinib in Subjects with Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumors
Chair:
Dr. Herbert Loong
Eligibility:
Patients with locally advanced, metastatic, and/or unresectable GIST, and have received prior therapy with imatinib. Patient should also have adequate haematologic, renal and hepatic function.Objectives:
To determine the efficacy and evaluate efficacy Parameters of bezuclastinib +sunitinib vs sunitinib in subjects with GIST
(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.
(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
(HCC078)
Stereotactic Body Radiotherapy (SBRT) in Advanced Hepatocellular Carcinoma with Oligoprogression on Atezolizumab plus Bevacizumab
Chair:
Dr. Landon Chan
Eligibility:
Histologically proven hepatocellular cancer patients who has oligoprogression on Atezolizumab plus Bevacizumab. Patient should also have adequate haematologic, renal and hepatic function.Objectives:
To study the progression-free survival (PFS) with the addition of SBRT to oligo-progressive sites.
(HCC081)
A Phase III, Randomised, Open-label, Sponsor-blinded, Multicentre Study of Rilvegostomig in Combination with Bevacizumab with or without Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma (ARTEMIDE-HCC01)
Chair:
Prof. Stephen Chan
Eligibility:
Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histopathology/ cytology or clinically by AASLD criteria in cirrhotic patients. Must not have received prior systemic therapy for intermediate, advanced, or metastatic HCC. Patient should have at least one measurable lesion and adequate hematologic and hepatic function.Objectives:
Primary objectives:To demonstrate the efficacy of Arm A relative to Arm C by assessment of OS in participants with advanced HCC
Secondary objectives:
To demonstrate the efficacy of Arm B relative to Arm C by assessment of OS in participants with advanced HCC
(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
(LUN109)
Neoadjuvant Sacituzumab Govitecan plus Pembrolizumab in Resectable Non-Small Cell Lung Cancer: an open-label, multicenter, single arm phase 2 study
Chair:
Dr. Molly Li
Eligibility:
Key Eligibility Criteria:- Stage II to III NSCLC planned for surgical resection
- Absence of EGFR mutation or ALK rearrangement
Objectives:
Study Treatment:- Neoadjuvant Pembrolizumab plus Sacituzumab govitecan followed by surgical resection followed by adjuvant pembrolizumab
(LUN110)
A Phase 2 Platform Study Evaluating the Safety and Efficacy of Novel Treatment Combinations in Patients With Lung Cancer(VELOCITY-Lung) Substudy-01: Patients With No Prior Systemic Treatment for Metastatic Non–Small-Cell Lung Cancer (mNSCLC)
Chair:
Dr. Molly Li
Eligibility:
Key Eligibility Criteria:- Stage IV NSCLC
- Treatment naïve
- Absence of actionable alterations (e.g. EGFR, ALK, ROS1)
Objectives:
Study Treatment:- Novel immunotherapy and chemotherapy combination
(LUN113)
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Tarlatamab Therapy in Subjects With Limited-Stage Small-Cell Lung Cancer (LS-SCLC) who Have not Progressed Following Concurrent Chemoradiation Therapy (DeLLphi-306)
Chair:
Dr. Molly Li
Eligibility:
Male and female subjects (age ≥ 18 years [or legal adult age within country, whichever is older]) with histologically or cytologically confirmed SCLC who have been diagnosed and treated for LS-SCLC with concurrent chemotherapy and radiotherapy and have not progressedObjectives:
Hazard ratio (HR) of progression-free survival (PFS) by BICR between tarlatamab and placebo, for subjects with LS-SCLC who have not progressed per investigator assessment of RECIST 1.1 after completion of concurrent chemoradiation therapy consisting of etoposide and platinum (EP), and definitive radiation dose prior to start of new anti-cancer therapy (hypothetical strategy).
(LUN118)
An Open-Label, Phase 1/2 Study of ORIC-114 as a Single Agent or in Combination with Chemotherapy, in Patients with Advanced Solid Tumors Harboring an EGFR or HER2 Alteration
Chair:
Dr. Herbert Loong
Eligibility:
- Aged ≥18 years at the time of signing the informed consent
- Histologically or cytologically confirmed locally advanced or metastatic solid tumor with a documented EGFR or HER2 exon 20 insertion mutation or atypical EGFR mutation as determined by any nucleic acid-based diagnostic testing method, or HER2 amplification/overexpression as determined by an immunohistochemistry (IHC) or an in situ hybridization (ISH) test; all tests should be performed in a CLIA certified or equivalently accredited laboratory.
- Prior therapies:
- a. Part I Dose Escalation: NSCLC patients must have received platinum-based chemotherapy or other chemotherapy regimen if platinum-based chemotherapy was contraindicated or other available approved targeted agent unless the targeted agent was contraindicated. At time of enrolment, patients must have progressed on, be intolerant of, decline, or be ineligible for, all available standard of care therapies with proven benefit
- b. Part I Extension: See cohort specific eligibility in inclusion criterion 2 above
- c. Part II Dose Optimization: Patients in cohorts IIA and IIB must have received platinum-based chemotherapy or other chemotherapy regimen if platinum-based chemotherapy was contraindicated. At time of enrolment, patients must have progressed on, be intolerant of, decline, or be ineligible for, all available standard of care therapies with proven benefit
In addition:
- Cohort IIA: patients must be naïve to an EGFR exon 20 targeted agent, ie, must have declined or be ineligible for all available exon 20 targeted therapies with proven benefit
- Cohort IIB: patients must be naïve to a HER2 targeted TKI
- Cohort IIC: patients may have received a prior EGFR TKI - Agreement and ability to undergo pretreatment biopsy, provided the procedure is clinically feasible and not deemed unsafe by the investigator
- Measurable disease according to RECIST 1.1
- Patients with CNS involvement, which is either previously treated and controlled, or untreated and asymptomatic are eligible
- a. Patients requiring steroids must be at stable or decreasing doses for at least 2 weeks prior to first dose of the study drug
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the study drug are eligible
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function
- Able to swallow oral medication without chewing or crushing
- Women of childbearing potential must have a negative serum pregnancy test within 72 hours before starting study treatment
- Women of childbearing potential and men who are not surgically sterile must agree to use highly effective medically accepted method of birth control during the study and for 90 days after end of treatment
- Willing and able to give informed consent and comply with protocol requirements for the duration of the study
Objectives:
Part I: To assess the safety and tolerability of ORIC-114 as a single agentPart II: To select the optimal ORIC-114 RP2D for Phase 2 expansion cohorts
Parts I, II:
- To assess the pharmacokinetics (PK) of ORIC-114
- To evaluate the preliminary antitumor activity of ORIC-114 as a single agent
- To determine the preliminary intracranial activity of ORIC-114 in patients presenting with brain lesions at baseline
- To characterize and/or quantify metabolites of ORIC-114 in plasma
- To gain insight into molecular alterations which may confer tumor sensitivity to treatment with ORIC-114
(LUN120)
A Phase 1/2 Open-Label, Multicenter, First-In-Human Study of the Safety, Tolerability, Pharmacokinetics, and AntitumorActivity of BH-30643 in Adult Subjects with Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2Mutations (SOLARA)
Chair:
Dr. Molly Li
Eligibility:
- EGFR mutation positive NSCLC (exon 19 deletion or exon 21 L858R mutation) previously treated with 3rd generation EGFR TKI (eg osimertinib) and harbour an on-target resistance mutation (e.g. EGFR C797S, L718, and G724S mutation), OR
- EGFR atypical mutation positive NSCLC (eg EGFR S768I, EGFR G719X, EGFR L861Q mutation) previously treated with 1 line of prior EGFR TKI therapy, OR
- EGFR exon 20 insertion positive NSCLC, OR
- HER2 mutation positive NSCLC, OR
- Previously untreated EGFR mutation positive NSCLC (exon 19 deletion or exon 21 L858R mutation), OR
- Previously untreated EGFR atypical mutation positive NSCLC (EGFR S768I, EGFR G719X, EGFR L861Q mutation)
Objectives:
This is a phase I / II trial testing the safety and efficacy of a 4th generation EGFR TKI, BH-30643.
(LUN123)
A PHASE III, RANDOMIZED, OPEN-LABEL STUDY EVALUATING THE EFFICACY AND SAFETY OF DIVARASIB AND PEMBROLIZUMAB VERSUS PEMBROLIZUMAB AND PEMETREXED AND CARBOPLATIN OR CISPLATIN IN PATIENTS WITH PREVIOUSLY UNTREATED, KRAS G12C-MUTATED, ADVANCED OR METASTATIC NON-SQUAMOUS NON−SMALL CELL LUNG CANCER
Chair:
Dr. Molly Li
Eligibility:
Key Inclusion/Exclusion criteria- Stage IV NSCLC harbouring KRAS G12C mutation
- Treatment naïve
Objectives:
(NET002)
A PHASE 2/3, MULTICENTER, RANDOMIZED OPEN-LABEL STUDY OF ZANZALINTINIB VS EVEROLIMUS IN PARTICIPANTS WITH PREVIOUSLY TREATED, UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC NEUROENDOCRINE TUMORS
Chair:
Prof. Stephen Chan
Eligibility:
Histologically confirmed, locally advanced/unresectable or metastatic, well-differentiated Grade 1, 2, or 3 NETs of pancreatic origin or extra-pancreatic origin (extra-pancreatic includes primary tumor sites of non-pancreatic gastrointestinal, lung, thymus, other, and unknown primary site). Participants with a diagnosis of pNET and nonfunctional epNET can have received up to one line of prior systemic anticancer treatment for NET. Participants with functional epNET must have received one, and no more than one, line of prior systemic anticancer therapy (PRRT or chemotherapy) for NET. Patients should have adequate hepatic and renal function.Objectives:
Primary:- To evaluate PFS by BICR of zanzalintinib versus everolimus
Secondary:
- To evaluate ORR by BICR of zanzalintinib versus everolimus
- To evaluate OS of zanzalintinib versus everolimus
(NPC038)
NRG-HN011: A RANDOMIZED PHASE II STUDY OF NIVOLUMAB VERSUS NIVOLUMAB AND BMS-986016 (RELATLIMAB) AS MAINTENANCE TREATMENT AFTER FIRST-LINE TREATMENT WITH PLATINUM-GEMCITABINE-NIVOLUMAB FOR PATIENTS WITH EPSTEIN-BARR VIRUS-ASSOCIATED RECURRENT/METASTATIC NASOPHARYNGEAL CARCINOMA (REMAIN)
Chair:
Prof. Brigette Ma
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 if adding BMS-986016 (relatlimab) to nivolumab maintenance therapy shows a signal of improved progression-free survival (PFS).
(NPC040)
Phase I-II study of JS207 a bispecific antibody against PD1-VEGF in the treatment of recurrent/metastatic nasopharyngeal carcinoma
Chair:
Prof. Brigette Ma
Eligibility:
Adult patient must have histologically nasopharyngeal carcinoma with prior treatment. Patient must have adequate hematological, liver and renal function.Objectives:
Objective response rate (ORR), defined as the proportion of patients with complete response (CR) or partial response (PR) according to RECIST v.1.1
(PAN007)
A Randomized, Phase 2/3 Study Comparing BMS-986504 in Combination withNab-paclitaxel and Gemcitabine versus Placebo in Combination with Nab-paclitaxel and Gemcitabine in Participants with Untreated Metastatic Pancreatic Ductal Adenocarcinoma Harboring Homozygous MTAP Deletion
Chair:
Prof. Stephen Chan
Eligibility:
Histologically or cytologically confirmed diagnosis of metastatic PDAC. Evidence of homozygous MTAP deletion or MTAP loss detected in tumor tissue using a Sponsor-provided central test or a Sponsor pre-approved local test. Patient should have adequate liver and renal function.Objectives:
Primary:To evaluate PFS of BMS-986504 in combination with nab-p/gem vs placebo + nab-p/gem in participants with untreated metastatic PDAC with homozygous MTAP deletion
Secondary:
- To evaluate the efficacy of BMS-986504 in combination with nab-p/gem vs placebo + nab-p/gem in participants with untreated metastatic PDAC with homozygous MTAP deletion
- To explore potential relationships between BMS-986504 exposures and responses in participants with untreated metastatic PDAC with homozygous MTAP deletion
Exploratory:
- To assess the safety and tolerability of BMS-986504 in combination with nab-p/gem vs placebo + nab-p/gem in participants with untreated metastatic PDAC with homozygous MTAP deletion
- To evaluate potential candidate biomarkersa of efficacy and safety outcomes in the peripheral blood and tumor tissue specimens in participants with untreated metastatic PDAC with homozygous MTAP deletion
- To evaluate pharmacodynamic effects on biomarkersa in the peripheral blood and tumor tissue specimens in participants with untreated metastatic PDAC with homozygous MTAP deletion
- To assess the OS of BMS-986504 in combination with nab-p/gem vs placebo + nab-p/gem in participants with untreated metastatic PDAC with homozygous MTAP deletion
- To assess the PK of BMS-986504 in combination with nab-p/gem in participants with untreated metastatic PDAC with homozygous MTAP deletion
- To explore potential relationships between BMS-986504 exposures and responses in participants with untreated metastatic PDAC with homozygous MTAP deletion
(PST012)
A Phase 3 Randomized, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Previously Treated With Next-generation Hormonal Agent (NHA) and Taxane-based Chemotherapy
Chair:
Dr. Kenneth Wong
Eligibility:
Adult patient must have histologically confirmed Metastatic Castration-resistant Prostate Cancer (mCRPC) with prior treatment. Patient must have adequate hematological, liver and renal function.Objectives:
To compare MK-5684 to alternative abiraterone acetate or enzalutamide with respect to overall survival in participants with mCRPC.
(REN006)
A Phase 3, Randomized, Open-label Study of Belzutifan + Zanzalintinib Versus Cabozantinib in Participants with Advanced RCC who Experienced Disease Recurrence During or After Prior Adjuvant Anti-PD-1/L1 Therapy (LITESPARK-033)
Chair:
Dr. Kelvin Yan
Eligibility:
Patient who has histologically confirmed diagnosis of unresectable, advanced RCC with clear cell component (with or without sarcomatoid features) ie, Stage IV RCC per AJCC (8th Edition) and Disease recurrence during adjuvant anti-PD-1/L1 therapy or recurrence ≤24 months following the last dose of adjuvant anti-PD-1/L1 therapyObjectives:
To compare the combination of belzutifan and zanzalintinib versus cabozantinib in participants with advanced RCC who experienced disease recurrence during or after prior adjuvant anti-PD-1/L1 therapy.
(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
Eligibility:
Adult patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma previously untreated and are planned for curative treatment.Objectives:
To investigate changes in T-cell mediated immune response in patients undergoingRT alone or concurrent chemoradiotherapy (CRT) for nasopharyngeal carcinoma(NPC).
(TRA025)
Impact of Radiotherapy on the Dynamic Changes of Circulating Cell-free DNA in Patients with Hepatocellular Carcinoma
Chair:
Dr. Landon Chan