Clinical Trial of BMS-986504 in Recurrent GBM Patients

Conditions

• Glioblastoma WHO Grade IV

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• BMS-986504 — DRUG
  MTA cooperative PRMT5 inhibitor

Study Details

This is an open-label, multi-center, Phase 0/1 dose-escalation trial designed to enroll up to 12 total recurrent glioblastoma (rGBM) participants with confirmed MTAP loss/deletion in their archival or pretreatment biopsy tissue, who are scheduled for surgical resection. MTAP loss/deletion will be determined by next-generation sequencing (NGS). The trial will include a dose escalation design to evaluate the pharmacokinetics (PK) and safety and tolerability of BMS-986504 (MRTX1719). The trial will be composed of a Phase 0 component and an Expansion Phase 1 component. Participants with tumors demonstrating a positive PK response in the Phase 0 component of the study will be eligible to enroll into the the Phase 1 component that will include 21-day cycles of therapeutic dosing of BMS-986504.

Key Dates

First listed

Mar 19, 2025

Start date

Apr 28, 2025

Status verified

Mar 2026

Primary completion

Sep 28, 2026

Completion

Sep 28, 2027

Study Design

Enrollment

12 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Recurrent WHO Grade 4 Glioblastoma MTAP loss/deletion

Primary Outcome Measure

BMS-986504 Concentration in Tumor Tissue [ Time Frame: intraoperative ]

Central Contacts

• Phase 0 Navigator
  602-406-8605
  [email protected]

Locations (1)

Find similar trials in Phoenix, AZ