Recruitment Complete
Sponsor ID
20230223

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)

Sponsor ID
20230223
Clinicaltrials.gov ID
NCT06360354
EUCTIS ID
N/A
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 1
Product
AMG 193
Type
Interventional
Masking
None (Open Label)
Enrollment
120
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Secondary Outcome Measures

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)

Locations

Location
Status
Contact Us
Location
City of Hope National Medical Center
Duarte, CA, United States, 91010
Status
Recruiting
Location
Cleveland Clinic Foundation
Cleveland, OH, United States, 44195
Status
Recruiting
Location
Comprehensive Blood and Cancer Center
Bakersfield, CA, United States, 93309
Status
Recruiting
Location
City of Hope Orange County Lennar Foundation Cancer Center
Duarte, CA, United States, 91010
Status
Recruiting
Location
Comprehensive Cancer Centers of Nevada
Las Vegas, NV, United States, 89169
Status
Terminated
Location
Epworth Healthcare
St Albans, VIC, Australia, 3021
Status
Recruiting
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