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NCT06360354 · ClinicalTrials.gov registry record · Phase 1

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 1 study of Advanced Gastrointestinal, Biliary Tract, and Pancreatic Cancers, sponsored by Amgen.

Recruiting
Registry status
Phase 1
Development phase
350
Enrollment target
20
Study locations

NCT06360354: Recruiting Phase 1 study of Advanced Gastrointestinal, Biliary Tract, and Pancreatic Cancers, sponsored by Amgen.

NCT06360354 is a Phase 1 study of Advanced Gastrointestinal, Biliary Tract, and Pancreatic Cancers that is actively recruiting participants, run by Amgen. The registered enrollment target is 350 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (483% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06360354, a Phase 1 study of Advanced Gastrointestinal, Biliary Tract, and Pancreatic Cancers, is actively recruiting participants, sponsored by Amgen.

RECRUITING
Registry status
Phase 1
Development phase
350 participants
Enrollment target
20
Study locations

Study 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.

Interventions

  • DRUG Gemcitabine
  • DRUG Nab-paclitaxel
  • DRUG RMC-6236
  • DRUG AMG 193
  • DRUG Modified FOLFIRINOX

Study Locations (20)

California

  • Comprehensive Blood and Cancer Center - Bakersfield
  • City of Hope National Medical Center - Duarte
  • City of Hope Orange County Lennar Foundation Cancer Center - Duarte
  • University of California San Diego Moores Cancer Center - La Jolla
  • Translational Research in Oncology US Inc, Trio Central Pharmacy - Los Angeles
  • University of California Los Angeles - Santa Monica

Connecticut

  • Hartford Hospital - Hartford
  • Yale University - New Haven
  • Norwalk Hospital - Norwalk

Massachusetts

  • Beth Israel Deaconess Medical Center - Boston
  • Dana-Farber Cancer Institute - Boston

Colorado

  • Rocky Mountain Cancer Centers - Aurora

Illinois

  • University of Chicago - Chicago

Indiana

  • Indiana University - Indianapolis

Kentucky

  • Norton Cancer Institute - Louisville

Missouri

  • Washington University - St Louis

Trial Details

FieldValue
Enrollment Target 350 participants
Start Date 2024-05-29
Est. Completion 2029-02-25
Phase Phase 1
Amgen

558 total trials

What NCT06360354 shows while recruiting

NCT06360354 is an interventional study that assigns participants to a tested intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (483% higher).

The record links to 1 condition, with Advanced Gastrointestinal, Biliary Tract, and Pancreatic Cancers appearing as the primary indexed condition, and to 5 interventions - of which Gemcitabine is the first listed.

NCT06360354 names 20 study sites across 12 states, led by California, Connecticut, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT06360354 about?

NCT06360354 is a clinical study titled "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)". 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 gastroin...

What is the current status of trial NCT06360354?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 350 participants. The study started on 2024-05-29. Estimated completion is 2029-02-25.

What conditions does trial NCT06360354 study?

This clinical trial studies the following conditions: Advanced Gastrointestinal, Biliary Tract, and Pancreatic Cancers.

What interventions are being tested in trial NCT06360354?

The interventions under investigation include: Gemcitabine (DRUG), Nab-paclitaxel (DRUG), RMC-6236 (DRUG), AMG 193 (DRUG), Modified FOLFIRINOX (DRUG).

Who is sponsoring clinical trial NCT06360354?

This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06360354 being conducted?

This trial has 20 study locations across California, Colorado, Connecticut, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT06360354's enrollment target sits among peer trials

350 97th of 2000 higher than 1,903 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06360354, the US trial registry maintained by the National Library of Medicine. NCT06360354 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.