Recruiting
Phase 1
Phase 2

BMS-986504

Sponsor:

Ankit Mangla, MD

Code:

NCT07549022

Conditions

Malignant Peripheral Nerve Sheath Tumors

MPNST

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

BMS-986504

Study Details

Brief summary:

People who have a cancer called MPNST, or Malignant Peripheral Nerve Sheath Tumor, may be eligible for this study. The purpose of this study is to see if a new medicine called BMS-986504 may work better than other available medicines for people with MPNST. Methylthioadenosine Phosphorylase (MTAP) loss is a gene mutation that some people have. MTAP loss seems to increase the chance that BMS-986504 can kill MPNST cancer cells. People who are missing MTAP from their tumor may be able to enroll in this study. Treating MPNST based on MTAP loss is considered experimental and is not approved by the US Food and Drug Administration (FDA) for determining whether BMS-98650 will be active against cancer. The purpose of this study is to evaluate the safety and effectiveness of BMS-986504 in participants with MPNST.

Conditions

Malignant Peripheral Nerve Sheath Tumors

MPNST

Study ID

NCT07549022

Start date

Aug, 2026

Status verified date

Aug, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male or female participants ≥ 12 years of age at the time of screening.
  • Ability to understand and willingness to sign documentation of informed consent if ≥ 18 years of age or documentation of assent if 12-17 years of age.
  • Pathohistological verification of MPNST.

  • Measurable disease (size of primary tumor and metastatic lesions can be trended by CT or MRI scans).
  • Unresectable (locally advanced or metastatic) disease.
  • Confirmation of homozygous MTAP deletion by next generation sequencing
  • Recovery from the adverse effects of prior therapy at the time of enrollment to baseline or ≤ Grade 1 (excluding alopecia, peripheral neuropathy, and parameters superseded by other eligibility criteria \[eg, hematology parameters\]). Note: Participants with prior endocrine adverse effects are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic.
  • Recovery from the acute toxic effects (≤ grade 1 as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events v5.0) of all prior chemotherapy prior to the entering study (exceptions: alopecia, anorexia, mass pain).
  • Normal marrow function and recovery of blood cell counts from any myelosuppressive chemotherapy prior to entering study:

  • Peripheral absolute neutrophil count (ANC) ≥ 1500/mcL (microliter).
  • Hemoglobin ≥ 9 g/dL (packed red blood cell transfusion is not allowed up to 14 days prior to starting BMS-986504 treatment to meet eligibility).
  • Platelet count ≥ 100,000/mcL (microliter) (platelet transfusion is not allowed up to 14 days prior to starting BMS-986504 treatment to meet eligibility).
  • Adequate organ function, including:

  • Liver function:

  • Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) for age, or ≤ 3 x ULN if associated with liver metastatic disease or Gilbert's disease).
  • ALT (alanine transaminase) and AST (aspartate aminotransferase) < 3 x ULN for age, or < 5 x ULN if associated with liver metastatic disease.
  • Serum albumin ≥ 2.0 g/dL.
  • PT (prothrombin time) and/or INR (International Normalized Ratio) ≤ 1.5 x ULN, or within therapeutic range if receiving anticoagulant therapy.
  • Renal function:

  • Creatinine < 1.5 times institutional ULN for age.
  • Performance status at time of screening:

  • ECOG (Eastern Cooperative Oncology Group) performance status 0-1 for participants ≥ 18 years old.
  • Lansky performance status (ages 12-15) or Karnofsky performance status (ages 16-17) ≥ 50.
  • Individuals of childbearing potential (IOCBP) must practice effective contraception during the trial.

Exclusion Criteria:

  • Participants who have been treated previously with a PRMT5 inhibitor.
  • Participants who are unable to swallow tablets.
  • History of gastrointestinal disease, inflammatory bowel disease, major gastric surgery or other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study treatment or result in inability to swallow oral medications.
  • Participants with active drug use.
  • Any botanical preparation (e.g., herbal supplements or traditional Chinese medicines) intended to treat the disease under study received within 4 weeks prior to randomization. The concurrent use of any botanical preparation is not permitted while on study.
  • Ongoing need for a medication known as a strong inhibitor or strong inducer of CYP3A4 and/or P-gp or a PPI (proton pump inhibitor) that cannot be switched to an alternative treatment prior to randomization.

Study Design

Enrollment

17 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BMS-986504

Participants will receive BMS-986504 on Days 1-28 of each cycle. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of consent.

Interventions

BMS-986504

Participants will receive 600 milligrams (mg) of BMS-986504 taken orally (by mouth) on Days 1-28 of each 28-day cycle. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of consent (up to 2 years). Participants who experience dose-limiting toxicity can be transitioned to 400 mg daily, then 200 mg daily of BMS-986504, or taken off the clinical trial.

Nine participants will be enrolled in stage 1. If ≥ 1 participant demonstrates a complete or partial response in stage 1, the trial will proceed to stage 2, where an additional eight participants will be enrolled. If there are no responses or significant safety concerns arise, the trial will be halted.

Primary outcome measure

  • Objective response rate (ORR) [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

Ankit Mangla, MD

216-844-6031ankit.mangla@uhhospitals.org

Locations

University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Ankit Mangla, MD

216-844-6031ankit.mangla@uhhospitals.org

Principal Investigator:

Ankit Mangla, MD

More Information

Sponsor

Ankit Mangla, MD

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Keywords

  • BMS-986504

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ankit Mangla, MD on 2026-08-11.