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Evaluating AMG 193 with other therapies for advanced gastrointestinal and pancreatic cancers

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

Phase 1 Interventional Amgen · NCT06360354

This study is testing a new cancer drug called AMG 193 combined with other treatments to see if it can help adults with advanced gastrointestinal and pancreatic cancers that have a specific genetic change.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment350 (estimated)
Ages18 Years to 100 Years
SexAll
SponsorAmgen Industry-sponsored
Drugs / interventionsRadiation
Locations77 sites (Bakersfield, California and 76 other locations)
Trial IDNCT06360354 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and maximum tolerated dose of AMG 193, a PRMT5 inhibitor, in combination with other cancer therapies for adults with advanced gastrointestinal, biliary tract, or pancreatic cancers that have a specific genetic deletion (MTAP-deletion). Participants will receive AMG 193 alongside treatments like Gemcitabine and Nab-paclitaxel. The study aims to determine how well these combinations work and their safety profile in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced adenocarcinoma of the pancreas and a confirmed homozygous MTAP-deletion.

Not a fit: Patients who have previously received MAT2A or PRMT5 inhibitors or those with certain cardiovascular and pulmonary conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced cancers that currently have limited effective therapies.

How similar studies have performed: While this approach is novel in targeting MTAP-deleted cancers, similar studies with other targeted therapies have shown promise in treating advanced cancers.

Eligibility criteria

Show full inclusion / exclusion 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.
* Radiation therapy within 28 days of first dose.
* Major surgery within 28 days of first dose of Anvumetostat.
* Cardiovascular and pulmonary exclusion criteria as defined in the protocol.
* 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.
* Adequate organ function as defined in the protocol.

Exclusion:

* Prior treatment with aMAT2A inhibitor, a PRMT5 inhibitor, or a MAPK pathway inhibitor, including KRAS inhibitors.
* Cardiovascular and pulmonary exclusion criteria as defined in the protocol.
* 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.

Where this trial is running

Bakersfield, California and 76 other locations

+27 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Advanced Gastrointestinal, Biliary Tract, and Pancreatic CancersAdvanced CancerMethylthioadenosine PhosphorylaseAMG 193Oncology
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.