BMS-986504 for Glioblastoma

Recruiting in Palo Alto (17 mi)

Overseen byNader Sanai, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Nader Sanai

No Placebo Group

Trial Summary

What is the purpose of this trial?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 Criteria

This trial is for up to 9 people with recurrent glioblastoma (rGBM) who have a specific genetic change called MTAP loss/deletion in their tumor. They must be scheduled for surgery and the genetic change is confirmed by advanced DNA testing.

Inclusion Criteria

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

Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other procedures

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

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Exclusion Criteria

Inability to undergo MRI brain with intravenous (IV) contrast

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.)

Treatment with another investigational drug or other intervention within 5 half-lives of the investigational product whichever is longer

+9 more

Participant Groups

The study tests BMS-986504, a new drug, in two phases: an initial phase to understand how the body processes it and its safety, followed by a longer treatment phase if early results are positive.

1Treatment groups

Experimental Treatment

Group I: Recurrent WHO Grade 4 Glioblastoma MTAP loss/deletionExperimental Treatment1 Intervention