drugset / Trial / NCT07076121

A Study Comparing Navlimetostat (BMS-986504) in Combination With Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine in Participants With Untreated Metastatic Pancreatic Ductal Adenocarcinoma With Homozygous MTAP Deletion (MountainTAP-30)

NCT07076121

Phase 2/3 Active not recruiting 470 enrolled Bristol-Myers Squibb
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to assess the safety and efficacy of Navlimetostat (BMS-986504), a selective, MTA-cooperative PRMT5 inhibitor, in combination with Nab-paclitaxel/Gemcitabine (nab-p/gem) versus placebo in combination with nab-p/gem, in participants with untreated metastatic Pancreatic Ductal Adenocarcinoma (PDAC) with homozygous methylthioadenosine phosphorylase (MTAP) deletion.

Timeline

Start
2025-10-23
Primary completion
2029-05-03
Completion
2029-05-03

Drugs

EvaluationDrugModalityDoseRoute
Subject BMS-986504 Unknown
Background Gemcitabine Small molecule
Background Paclitaxel Small molecule