Trials / Recruiting
RecruitingNCT06360354
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)
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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 350 (estimated)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2024-05-29
- Primary completion
- 2027-02-26
- Completion
- 2029-02-25
- First posted
- 2024-04-11
- Last updated
- 2026-03-31
Locations
77 sites across 16 countries: United States, Australia, Belgium, Canada, China, Denmark, France, Germany, Greece, Hong Kong, Italy, Japan, Netherlands, Spain, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06360354. Inclusion in this directory is not an endorsement.