Actively Recruiting
Clinical Trial of BMS-986504 in Recurrent GBM Patients
Led by Nader Sanai · Updated on 2025-06-19
9
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Trial of BMS-986504 in Recurrent GBM Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of glioblastoma by 2021 WHO criteria with progression after prior tumor-directed therapy including surgery or biopsy and radiotherapy
- Archival tissue showing MTAP loss/deletion confirmed by next-generation sequencing
- Measurable disease pre-surgery with at least one lesion 1 cm or larger
- Recovery from chemotherapy effects to mild or less (Grade 1 or lower) except certain neuropathy and alopecia; at least 21 days washout after last chemo dose
- Age 18 years or older at consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Adequate bone marrow, liver, kidney, and coagulation function as defined by laboratory values
- Ability to swallow oral medications without crushing or chewing
- Negative pregnancy test or no longer of childbearing potential
- For females of reproductive potential, use of effective contraception before and during study and for 7 months after treatment ends
- Agreement not to breastfeed during study and for 7 months after treatment
- For males of reproductive potential, use of condoms or effective contraception during study and for 4 months after treatment
- Willingness and ability to comply with study visits and procedures
- Understanding and voluntary written informed consent obtained before any screening
You will not qualify if you...
- Unable to undergo brain MRI with contrast
- Active systemic bacterial, fungal, or detectable viral infection requiring treatment or with fever above 38.5�B0C
- Cardiovascular problems including low heart function (LVEF <50%), prolonged QTc interval >480 msec (except right bundle branch block), or significant heart conditions within 6 months prior
- Symptomatic or radiographic leptomeningeal disease
- Other severe or uncontrolled medical conditions that pose safety risks or affect protocol compliance
- Unresolved toxicities from prior therapy greater than Grade 1 except alopecia; chronic Grade 2 toxicities may be considered after discussion
- Treatment with other investigational drugs within 5 half-lives of their use
- Prior treatment with another PRMT5 inhibitor
- Known allergies to components of BMS-986504 or its formulation
- Use of strong CYP3A4/P-gp inhibitors or inducers unless alternatives used
- Concurrent use of medications that prolong QT interval unless discontinued with appropriate washout
- Receipt of live or attenuated vaccines within 30 days before first treatment; inactivated flu vaccines allowed without restriction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
Actively Recruiting
Research Team
P
Phase 0 Navigator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here