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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) | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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)

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 193 in Combination With Other Therapies in Subjects With Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers With Homozygous MTAP-deletion

NCT06360354•Amgen

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 100 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subprotocol B
•Inclusion:
•Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
•Histologically or cytologically confirmed diagnosis of metastatic and/or unresectable (locally advanced) adenocarcinoma of the pancreas.
•Tumor tissue (FFPE sample) or an archival block must be available. Participants without archived tumor tissue available may be allowed to enroll by undergoing tumor biopsy before dosing.
•Homozygous MTAP-deletion.
•Disease measurable as defined by RECIST v1.1.
•Adequate organ function as defined in the protocol.
•Exclusion:
•Prior treatment with a MAT2A inhibitor or a PRMT5 inhibitor.
+2 more criteria

Exclusion Criteria

•Gastrointestinal tract disease causing the inability to take PO medication, malabsorption syndrome, requirement for IV alimentation, gastric/jejunal tube feeds, uncontrolled inflammatory gastrointestinal disease (eg, Crohn's disease, ulcerative colitis).
•History of solid organ transplantation.
•Subprotocol C
•Inclusion:
•Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
•Histologically or cytologically confirmed diagnosis of metastatic and/or unresectable (locally advanced) adenocarcinoma of the pancreas.
•Homozygous MTAP-deletion.
•Rat Sarcoma Viral Oncogene Homolog (RAS) mutation
•Received at least 1 prior systemic therapy for advanced or metastatic PDAC.
•Disease measurable as defined by RECIST v1.1.
+5 more criteria

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

Key Dates

Start Date

May 29, 2024

Primary Completion Date

February 26, 2027

Completion Date

February 25, 2029

Last Updated

February 12, 2026

Enrollment

350

ESTIMATED participants

Conditions

Advanced Gastrointestinal, Biliary Tract, and Pancreatic Cancers

Interventions

AMG 193

DRUG

Gemcitabine

DRUG

Nab-paclitaxel

DRUG

Modified FOLFIRINOX

DRUG

RMC-6236

DRUG

Contacts

Amgen Call Center

CONTACT

866-572-6436 medinfo@amgen.com