RecruitingEarly Phase 1NCT06883747

Clinical Trial of BMS-986504 in Recurrent GBM Patients

A Phase 0/1 Study of BMS-986504, a MTA Cooperative PRMT5 Inhibitor in Recurrent Glioblastoma Participants With MTAP Deleted Tumors Scheduled for Resection to Evaluate Central Nervous System (CNS) Penetration With PK-Triggered Expansion Cohort

Sponsor

Nader Sanai

Enrollment

9 participants

Start Date

Apr 28, 2025

Study Type

INTERVENTIONAL

Conditions

Glioblastoma WHO Grade IV

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing BMS-986504, a new oral experimental drug, in people with glioblastoma (an aggressive brain tumor) that has come back after standard treatment. The drug targets a specific genetic deletion found in some glioblastoma tumors. **You may be eligible if...** - You are 18 or older - You have been diagnosed with glioblastoma that has progressed after previous treatment, which must have included surgery and radiation - Your tumor has measurable disease visible on brain scans - Your overall health and organ function are within acceptable ranges - You are able to swallow tablets whole **You may NOT be eligible if...** - You cannot have an MRI with contrast - You have an active serious infection (bacterial, fungal, or viral including HIV or hepatitis B/C) - You have significant heart problems (including heart failure, recent heart attack, or irregular heart rhythm) - You are pregnant or breastfeeding - You have previously been treated with a PRMT5 inhibitor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBMS-986504

MTA cooperative PRMT5 inhibitor

Locations(1)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

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NCT06883747

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