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Anvumetostat for Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers

This study is testing a new drug called Anvumetostat in combination with other standard treatments like Gemcitabine, Nab-paclitaxel, or Modified FOLFIRINOX for people with advanced gastrointestinal, biliary tract, or pancreatic cancers. To join, your cancer must have a specific genetic change called a homozygous methylthioadenosine phosphorylase (MTAP)-deletion. The main goals are to find the safest and most effective dose of Anvumetostat and to understand its side effects. This study is currently recruiting about 120 participants aged 18 to 100 years old. Success will be measured by how many participants experience side effects and how severe they are.

Study design
This interventional study plans to enroll 120 participants. It is not specified if it is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
You would be monitored for side effects for up to approximately 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06360354

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)

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
Amgen
~120 participants
Updated 2026-06-01 on ClinicalTrials.gov
What's tested:AnvumetostatGemcitabineNab-paclitaxelModified FOLFIRINOXRMC-6236

At a glance

Recruiting sites
0 of 77 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants Experiencing Dose Limiting Toxicities (DLT)
Measured over Up to 28 days
+2 more outcomes measured

Conditions

Advanced Gastrointestinal, Biliary Tract, and Pancreatic Cancers

Explore related trials

Malignant Digestive System NeoplasmMalignant neoplasm of biliary tractPancreatic CarcinomaSolid NeoplasmMTAP Gene

Where it's being run

77 sites across 46 states
California6
France4
Italy4
Connecticut3
Washington3
Victoria3
Belgium3
Germany3

Study leadership

  • MD · STUDY_DIRECTOR · Amgen

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

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.
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.
Prior treatment with aMAT2A inhibitor, a PRMT5 inhibitor, or a MAPK pathway inhibitor, including KRAS inhibitors.
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.

What this trial measures

  • Number of Participants Experiencing Dose Limiting Toxicities (DLT)Up to 28 days
  • Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE)Up to approximately 2 years

    Any clinically significant changes in vital signs, electrocardiogram, or lab parameters will be recorded as TEAEs.

  • Number of Participants Experiencing Serious Adverse Events (SAE)Up to approximately 2 years