A Study Evaluating Anvumetostat in Combination With other Therapies in Participants With Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers With Homozygous Methylthioadenosine Phosphorylase (MTAP)-deletion (MTAPESTRY 103)
Study Details
The study aims to determine maximum tolerated dose (MTD) or recommended combination dose of the MTA-cooperative PRMT5 inhibitor Anvumetostat 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 Anvumetostat administered in combination with other therapies in adult participants with metastatic or locally advanced MTAP-deleted gastrointestinal, biliary tract, or pancreatic cancers.
Protocol Summary
Number of Participants Experiencing Dose Limiting Toxicities (DLT)
Timeframe: Up to 28 days
Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE)
Timeframe: Up to approximately 2 years
Number of Participants Experiencing Serious Adverse Events (SAE)
Timeframe: Up to approximately 2 years
Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Timeframe: Up to approximately 2 years
Disease Control (DC) per RECIST v1.1
Timeframe: Up to approximately 2 years
Duration of Response (DOR) per RECIST v1.1
Timeframe: Up to approximately 2 years
Time to Response (TTR) per RECIST v1.1
Timeframe: Up to approximately 2 years
Overall Survival (OS) per RECIST v1.1
Timeframe: Up to approximately 2 years
Progression-free Survival (PFS) per RECIST v1.1
Timeframe: Up to approximately 2 years
Maximum Plasma Concentration (Cmax) of Anvumetostat
Timeframe: Up to Day 1 of Cycle 5 (one cycle = 21 or 28 days)
Time to Maximum Plasma Concentration (tmax) of Anvumetostat
Timeframe: Up to Day 1 of Cycle 5 (one cycle = 21 or 28 days)
Area Under the Plasma Concentration-time Curve (AUC) of Anvumetostat
Timeframe: Up to Day 1 of Cycle 5 (one cycle = 21 or 28 days)
Cmax of RMC-6236
Timeframe: Up to Day 1 of Cycle 5 (one cycle = 21 days)
Tmax of RMC-6236
Timeframe: Up to Day 1 of Cycle 5 (one cycle = 21 days)
AUC of RMC-6236
Timeframe: Up to Day 1 of Cycle 5 (one cycle = 21 days)