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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)

NCT06360354 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2026-03-31

No results posted yet for this study

Summary

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.

Conditions

  • Advanced Gastrointestinal, Biliary Tract, and Pancreatic Cancers

Interventions

DRUG

Anvumetostat

Administered Orally

DRUG

Gemcitabine

Administered IV

DRUG

Nab-paclitaxel

Administered IV

DRUG

Modified FOLFIRINOX

Modified FOLFIRINOX consists of irinotecan, 5-FU, LV, and oxaliplatin administered IV

DRUG

RMC-6236

Administered orally

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-29
Primary Completion
2027-02-26
Completion
2029-02-25
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • China
  • Denmark
  • France
  • Germany
  • Greece
  • Hong Kong
  • Italy
  • Japan
  • Netherlands
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06360354 on ClinicalTrials.gov