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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
350
Administered Orally
Administered IV
Administered IV
Modified FOLFIRINOX consists of irinotecan, 5-FU, LV, and oxaliplatin administered IV
Administered orally
Comprehensive Blood and Cancer Center
Bakersfield, California, United States
RECRUITINGCity of Hope National Medical Center
Duarte, California, United States
RECRUITINGCity of Hope Orange County Lennar Foundation Cancer Center
Duarte, California, United States
RECRUITINGUniversity of California San Diego Moores Cancer Center
La Jolla, California, United States
Number of Participants Experiencing Dose Limiting Toxicities (DLT)
Time frame: Up to 28 days
Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE)
Any clinically significant changes in vital signs, electrocardiogram, or lab parameters will be recorded as TEAEs.
Time frame: Up to approximately 2 years
Number of Participants Experiencing Serious Adverse Events (SAE)
Time frame: Up to approximately 2 years
Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Time frame: Up to approximately 2 years
Disease Control (DC) per RECIST v1.1
Time frame: Up to approximately 2 years
Duration of Response (DOR) per RECIST v1.1
Time frame: Up to approximately 2 years
Time to Response (TTR) per RECIST v1.1
Time frame: Up to approximately 2 years
Overall Survival (OS) per RECIST v1.1
Time frame: Up to approximately 2 years
Progression-free Survival (PFS) per RECIST v1.1
Time frame: Up to approximately 2 years
Maximum Plasma Concentration (Cmax) of AMG193
Time frame: Up to Day 1 of Cycle 5 (one cycle = 21 or 28 days)
Time to Maximum Plasma Concentration (tmax) of AMG193
Time frame: Up to Day 1 of Cycle 5 (one cycle = 21 or 28 days)
Area Under the Plasma Concentration-time Curve (AUC) of AMG 193
Time frame: Up to Day 1 of Cycle 5 (one cycle = 21 or 28 days)
Cmax of RMC-6236
Time frame: Up to Day 1 of Cycle 5 (one cycle = 21 days)
Tmax of RMC-6236
Time frame: Up to Day 1 of Cycle 5 (one cycle = 21 days)
AUC of RMC-6236
Time frame: Up to Day 1 of Cycle 5 (one cycle = 21 days)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Translational Research in Oncology US Inc, Trio Central Pharmacy
Los Angeles, California, United States
RECRUITINGUniversity of California Los Angeles
Santa Monica, California, United States
RECRUITINGRocky Mountain Cancer Centers
Aurora, Colorado, United States
RECRUITINGHartford Hospital
Hartford, Connecticut, United States
RECRUITINGYale University
New Haven, Connecticut, United States
RECRUITINGNorwalk Hospital
Norwalk, Connecticut, United States
RECRUITING...and 67 more locations