A Study Evaluating AMG 193 in Combination With Other Therapies in Participants With Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers With Homozygous Methylthioadenosine Phosphorylase (MTAP)-Deletion (MTAPESTRY 103)
- Conditions
- Advanced Gastrointestinal, Biliary Tract, and Pancreatic Cancers
- Interventions
- Registration Number
- NCT06360354
- Lead Sponsor
- Amgen
- Brief Summary
The study aims to determine maximum tolerated dose (MTD) or recommended combination dose of the MTA-cooperative PRMT5 inhibitor AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-deleted gastrointestinal, biliary tract, or pancreatic cancers. The study also aims to determine the safety profile of AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced MTAP-deleted gastrointestinal, biliary tract, or pancreatic cancers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 350
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Subprotocol B: Pancreatic Ductal Adenocarcinoma (PDAC) Arm A AMG 193 Part 1: Participants with MTAP-deleted PDAC will receive doses of AMG 193 orally in combination with gemcitabine and nab-paclitaxel IV. Part 2: Participants with MTAP-deleted PDAC will receive the recommended dose of AMG 193 in combination with gemcitabine and nab-paclitaxel. Subprotocol B: Pancreatic Ductal Adenocarcinoma (PDAC) Arm A Gemcitabine Part 1: Participants with MTAP-deleted PDAC will receive doses of AMG 193 orally in combination with gemcitabine and nab-paclitaxel IV. Part 2: Participants with MTAP-deleted PDAC will receive the recommended dose of AMG 193 in combination with gemcitabine and nab-paclitaxel. Subprotocol B: Pancreatic Ductal Adenocarcinoma (PDAC) Arm A Nab-paclitaxel Part 1: Participants with MTAP-deleted PDAC will receive doses of AMG 193 orally in combination with gemcitabine and nab-paclitaxel IV. Part 2: Participants with MTAP-deleted PDAC will receive the recommended dose of AMG 193 in combination with gemcitabine and nab-paclitaxel. Subprotocol B: PDAC Arm B AMG 193 Part 1: Participants with MTAP-deleted PDAC will receive doses of AMG 193 orally in combination with mFOLFIRINOX (irinotecan, fluorouracil, leucovorin calcium, oxaliplatin) IV. Part 2: Participants with MTAP-deleted PDAC will receive the recommended dose of AMG 193 in combination with mFOLFIRINOX. Subprotocol B: PDAC Arm B Modified FOLFIRINOX Part 1: Participants with MTAP-deleted PDAC will receive doses of AMG 193 orally in combination with mFOLFIRINOX (irinotecan, fluorouracil, leucovorin calcium, oxaliplatin) IV. Part 2: Participants with MTAP-deleted PDAC will receive the recommended dose of AMG 193 in combination with mFOLFIRINOX. Subprotocol C: Dose Exploration AMG 193 Part 1: Participants with MTAP-deleted PDAC will receive oral doses of AMG 193 and RMC-6236. Subprotocol C: Dose Exploration RMC-6236 Part 1: Participants with MTAP-deleted PDAC will receive oral doses of AMG 193 and RMC-6236. Subprotocol C: Dose Expansion AMG 193 Part 2: Participants with MTAP-deleted PDAC will receive oral doses of AMG 193 andRMC-6236. Subprotocol C: Dose Expansion RMC-6236 Part 2: Participants with MTAP-deleted PDAC will receive oral doses of AMG 193 andRMC-6236.
- Primary Outcome Measures
Name Time Method Number of Participants Experiencing Dose Limiting Toxicities (DLT) Up to 28 days Number of Participants Experiencing Serious Adverse Events (SAE) Up to approximately 2 years Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE) Up to approximately 2 years Any clinically significant changes in vital signs, electrocardiogram, or lab parameters will be recorded as TEAEs.
- Secondary Outcome Measures
Name Time Method Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) Up to approximately 2 years Disease Control (DC) per RECIST v1.1 Up to approximately 2 years Duration of Response (DOR) per RECIST v1.1 Up to approximately 2 years Time to Response (TTR) per RECIST v1.1 Up to approximately 2 years Overall Survival (OS) per RECIST v1.1 Up to approximately 2 years Progression-free Survival (PFS) per RECIST v1.1 Up to approximately 2 years Maximum Plasma Concentration (Cmax) of AMG193 Up to Day 1 of Cycle 5 (one cycle = 21 or 28 days) Time to Maximum Plasma Concentration (tmax) of AMG193 Up to Day 1 of Cycle 5 (one cycle = 21 or 28 days) Area Under the Plasma Concentration-time Curve (AUC) of AMG 193 Up to Day 1 of Cycle 5 (one cycle = 21 or 28 days) Cmax of RMC-6236 Up to Day 1 of Cycle 5 (one cycle = 21 days) Tmax of RMC-6236 Up to Day 1 of Cycle 5 (one cycle = 21 days) AUC of RMC-6236 Up to Day 1 of Cycle 5 (one cycle = 21 days)
Related Research Topics
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Trial Locations
- Locations (77)
Comprehensive Blood and Cancer Center
🇺🇸Bakersfield, California, United States
City of Hope National Medical Center
🇺🇸Duarte, California, United States
City of Hope Orange County Lennar Foundation Cancer Center
🇺🇸Duarte, California, United States
University of California San Diego Moores Cancer Center
🇺🇸La Jolla, California, United States
Translational Research in Oncology US Inc, Trio Central Pharmacy
🇺🇸Los Angeles, California, United States
University of California Los Angeles
🇺🇸Santa Monica, California, United States
Rocky Mountain Cancer Centers
🇺🇸Aurora, Colorado, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Norwalk Hospital
🇺🇸Norwalk, Connecticut, United States
Scroll for more (67 remaining)Comprehensive Blood and Cancer Center🇺🇸Bakersfield, California, United States