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RecruitingPhase 2

A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)

A Phase 2 Open-Label, Multi-Center Study of BMS-986504 as Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests BMS-986504 alone and with other cancer drugs for solid tumors that are advanced or have spread. It is for people whose tumors are missing both copies of the MTAP gene. Researchers will check safety, how the drug works in the body, and whether it helps fight the cancer.

This is an open-label, multicenter Phase 2 study evaluating BMS-986504 in participants with advanced and/or metastatic solid tumors that have MTAP deletion. The study includes a monotherapy component and a combination component in which BMS-986504 is given with other anti-cancer agents. The trial will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of BMS-986504 alone and in combination regimens.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • A tumor tissue test must confirm an advanced or spreading solid cancer that is missing both copies of the MTAP gene.
  • Some study groups require past standard treatment and cancer that grew during or after the latest treatment. No treatment aimed at a cure can be available, or you must be unable to have it or choose not to have it.
  • Other study groups require no past whole-body cancer treatment for cancer that cannot be removed by surgery or has spread.
  • You must have at least one tumor that can be measured using the study’s rules.
  • Blood-clotting tests must be no more than 1.5 times the upper normal limit, or 2 times that limit if you have liver cancer or cancer that has spread to the liver.
  • You must be fully active or able to do light work despite limits on heavy activity.

Who can't join

  • Past treatment with a PRMT5 or MAT2A inhibitor, which are types of cancer drugs.
  • Active cancer that has spread to the brain, or cancer in the lining around the brain and spinal cord. Treated brain tumors may be allowed if nerve-related symptoms are stable for at least 2 weeks and you take no steroids, or a stable or falling dose of no more than 10 mg of prednisone daily or an equal dose of another steroid.
  • Digestive problems or related conditions within the past 6 months that could keep your body from absorbing the study drug or keep you from swallowing pills.
  • Screening lab tests show that your organs are not working well enough.
  • Active hepatitis B or C, which are viral liver infections.
  • Other study rules may also affect whether you can join.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Participant must have histologically confirmed diagnosis of advanced and/or metastatic solid tumor malignancy with homozygous deletion of the MTAP gene detected in tumor tissue. * Depending on the cohort enrolled, participants must have received standard therapies appropriate for their tumor type and stage with disease progression on or after the most recent treatment (there must be no available treatment with curative intent or participant is ineligible or declines treatment) or be treatment-naïve with no prior systemic anticancer therapy for their unresectable or metastatic disease. * Participant must have presence of at least one measurable tumor lesion per RECIST v1.1 or mRECIST at baseline. * Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) must be ≤ 1.5 × ULN; subjects with liver metastasis or liver cancer must be ≤ 2 × ULN. * Participant must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria: * Participants must not have prior treatment with a PRMT5 or Methionine adenosyl transferase 2A (MAT2A) inhibitor. * Participants must not have active brain metastases or carcinomatous meningitis. Participants are eligible if brain metastases are adequately treated, and participants are neurologically stable for at least 2 weeks prior to enrollment without the use of corticosteroids or are on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent). * Participants must not have history of gastrointestinal disease or other gastrointestinal conditions within 6 months prior to enrollment (including uncontrolled nausea, vomiting, malabsorption syndrome or non-gastrointestinal fistula, gastrointestinal perforation, or intra-abdominal abscess) likely to alter absorption of study treatment or result in inability to swallow oral medications. * Participants must not have inadequate organ function, as determined by laboratory testing within the screening period. * Participants must not have active viral HBV or HCV hepatitis. * Other protocol defined inclusion/exclusion criteria applies.

Study sites (16)

CA

CO

GA

  • Emory University - Winship Cancer Institute · Atlanta, GA 30322Gideon T Dosunmu, Site 0178 · Study contactMore trials in Atlanta

MA

MD

MI

MN

NC

NY

TX

WA

WI