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Clinical Trial of BMS-986504 for Recurrent Glioblastoma

This study is testing a drug called BMS-986504 in people with recurrent glioblastoma (a type of brain cancer that has come back). The drug is a PRMT5 inhibitor, which means it targets a specific protein in cancer cells. To join, you must have glioblastoma (WHO Grade IV) that has progressed after previous treatments, including surgery and radiation. Your tumor must also show a specific genetic change called MTAP loss/deletion. Researchers will measure the amount of BMS-986504 in your tumor tissue during surgery and track any side effects for up to 15 months to see how safe and well-tolerated the drug is. The study aims to enroll up to 12 participants.

Study design
This is an open-label, multi-center Phase 0/1 study with a dose escalation design, involving up to 12 participants.
What's involved
You would receive BMS-986504 for 6 days before surgery, with the final dose given 3-5 hours before tumor removal. If eligible, you might then receive 21-day cycles of therapeutic dosing.
Compensation
Not stated in the trial record.
Follow-up
You will be monitored for treatment-related side effects for up to 30 days after your last dose, assessed over 15 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06883747

Clinical Trial of BMS-986504 in Recurrent GBM Patients

Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
Nader Sanai
~12 participants
Updated 2026-06-25 on ClinicalTrials.gov
What's tested:BMS-986504

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
BMS-986504 Concentration in Tumor Tissue
Measured over intraoperative
+5 more outcomes measured

Conditions

Glioblastoma WHO Grade IV

Explore related trials

GlioblastomaMTAP Gene

Where it's being run

1 sites across 1 states
Arizona1

Study leadership

  • Nader Sanai, MD · PRINCIPAL_INVESTIGATOR · Ivy Brain Tumor Center

Who to contact

Phase 0 Navigator
[email protected]
602-406-8605
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participants with the diagnosis of glioblastoma by the 2021 WHO criteria, who have progressed on or following previous tumor-directed therapy, which must have included a maximal safe resection (biopsy allowed if it was deemed unsafe to resect) and fractionated radiotherapy (RT).
Patients with archival tissue demonstrating MTAP loss/deletion confirmed through NGS will be qualified for Phase 0 portion of the study.
Participants must have measurable disease preoperatively, defined as at least 1 contrast-enhancing lesion, with 2 perpendicular measurements of at least 1 cm.
Participants who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events \[CTCAE\] Grade ≤ 1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to Day 1. A washout period of at least 21 days is required between the last chemotherapy dose and Day 1 (provided the participant did not receive RT).
Age ≥ 18 at time of consent
Have a performance status (PS) of ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) scale
Participant has adequate bone marrow and organ function as defined by the following laboratory values (as assessed by the local laboratory for eligibility):
Adequate Bone Marrow Function: Absolute neutrophil count ≥ 1,500/mcL; Platelets (at time of surgery) ≥ 100,000/mcL; Hemoglobin ≥ 9.0 g/dL (participants may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion.)
Adequate Hepatic Function: Total Bilirubin ≤ 1.5 X ULN; Participants with Gilbert's syndrome with a total bilirubin ≤ 2.0 times ULN and direct bilirubin within normal limits are permitted; AST (SGOT) ≤ 3 X institutional ULN; ALT (SGPT) ≤ 3 X institutional ULN
Adequate Renal Function: Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m2 by Chronic Disease Epidemiology Collaboration (CKD-EPI) equation; Serum creatinine ≤ 1.5 X ULN or estimated creatinine clearance \>/= 60 mL/min (calculated using Institutional standard method)
Coagulation Function: INR ≤ 1.5 X ULN
Ability to swallow oral medications without crushing or chewing.
Confirmed negative serum pregnancy test (β-hCG) before starting study treatment or participant who is no longer of childbearing potential due to surgical, chemical, or natural menopause.
For females of reproductive potential: use of highly effective contraception for at least 28 days prior to treatment and agreement to use such a method during study participation and for an additional 7 months after the end of treatment administration.
Females of child-bearing potential must agree not to breastfeed starting at screening, throughout the study period and for 7 months after final study drug administration.
For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner and avoid sperm donation for the duration of the study and for an additional 4 months after the end of treatment administration.
Agreement to adhere to Lifestyle Considerations throughout study duration.
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other procedures.
Participant understands the informed consent document and has voluntarily agreed to participate by giving written informed consent (personally or via legally authorized representative(s), and assent if applicable). Written informed consent for the protocol must be obtained prior to any screening procedures. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.

Exclusion

Inability to undergo MRI brain with intravenous (IV) contrast
Known active systemic bacterial infection (IV antibiotics or fever \> 38.5°C at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \[for example, hepatitis B surface antigen positive\]. Screening of viral infection is not required for enrollment.
Cardiovascular abnormalities including:
LVEF \< 50%
History of prolonged QTc, or QT interval corrected for heart rate using Fridericia's formula (QTcF) prolongation \> 480 msec, except for right bundle branch block.
Uncontrolled/symptomatic or significant cardiovascular conditions within 6 months prior to enrollment, including but not limited to any of the following: Cardiac angioplasty or stenting, unstable angina pectoris, myocardial infarction, stroke/transient ischemic attack, coronary artery bypass graft surgery, symptomatic peripheral vascular disease, New York Heart Association (NYHA) class III-IV congestive heart failure, pericarditis, atrial fibrillation or other arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, or Torsades de Pointes).
Symptomatic or radiographic leptomeningeal disease.
Known other concurrent severe and/or uncontrolled medical condition that, in the investigator's judgment, would cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol (e.g., Celiac disease, Crohn's disease, gastric bypass, malabsorption, chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections, etc.).
With the exception of alopecia, any unresolved toxicities from prior therapy greater than National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0) Grade 1 at the time of starting study treatment and patients with chronic Grade 2 unresolved toxicities may be eligible following discussion with the Principal Investigator.
Treatment with another investigational drug or other intervention within 5 half-lives of the investigational product whichever is longer.
Prior treatment with another PRMT5 inhibitor.
Known allergic reactions to components of BMS-986504: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol/macrogol, and talc.
Use of strong inhibitors and strong inducers of CYP3A4/P-gp. Consider using alternative medications, per Investigator judgment.
Concurrent use of medications known to prolong the QT interval (e.g., certain antiarrhythmics, antibiotics, antipsychotics, and antidepressants) unless discontinued for an appropriate washout period as determined by the investigator.
Participants who have received live/attenuated vaccine within 30 days of anticipated first treatment. The use of inactivated seasonal influenza vaccines (e.g., Fluzone®) will be permitted on study without restriction.

What this trial measures

  • BMS-986504 Concentration in Tumor Tissueintraoperative

    Total and unbound BMS-986504 concentration will be quantified in Gd-enhancing and Gd-non-enhancing tumor tissue collected during Phase 0 surgery.

  • Number of Treatment-Emergent Adverse EventsFrom date of enrollment until 30 days after last dose, assessed over 15 months

    Safety and tolerability of BMS-986504 will be assessed by tabulating (Number and Percent) Treatment-Emergent Adverse Events (TEAEs) according to the highest grade observed per participant for each event or category (per CTCAE v5.0). The analysis population includes participants who took at least one dose of the study drug.

  • Number of Treatment-Related Adverse EventsFrom date of first dose of study drug until 30 days after last dose, assessed over 15 months

    Safety and tolerability of BMS-986504 will be assessed by tabulating (Number and Percent) Treatment-Related Adverse Events (TEAEs) according to the highest grade observed per participant for each event or category (per CTCAE v5.0). The analysis population includes participants who took at least one dose of the study drug.

  • Number of Serious Adverse EventsFrom date of enrollment until 30 days after last dose, assessed over 15 months

    Safety and tolerability of BMS-986504 will be assessed by tabulating (Number and Percent) Serious Adverse Events (SAEs) according to the highest grade observed per participant for each event or category (per CTCAE v5.0). The analysis population includes participants who took at least one dose of the study drug.

  • Number of Clinical Laboratory AbnormalitiesFrom date of enrollment until 30 days after last dose, assessed over 15 months

    Safety and tolerability of BMS-986504 will be assessed by tabulating (Number and Percent) Clinical Laboratory Abnormalities according to the highest grade observed per participant for each event or category (per CTCAE v5.0). The analysis population includes participants who took at least one dose of the study drug.

  • Number of Drug-Related ToxicitiesFrom date of first dose of study drug until 30 days after last dose, assessed over 15 months

    Safety and tolerability of BMS-986504 will be assessed by tabulating (Number and Percent) Drug-Related Toxicities (defined by Dose Limiting Toxicities) according to the highest grade observed per participant for each event or category (per CTCAE v5.0). The analysis population includes participants who took at least one dose of the study drug.