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 9 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

Start date

Apr 28, 2025

Status verified

Jun 2025

Primary completion

Sep 28, 2026

Completion

Sep 28, 2027

Study Design

Enrollment

9 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)

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