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

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.

Eligibility

Age range

18–100 years

Sex

All

Healthy volunteers

No

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

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