Safety and drug-level testing of BMS-986504 for advanced solid tumors with MTAP deletion

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1, open-label trial gives single-agent BMS-986504 to adults with unresectable or metastatic solid tumors that have a homozygous MTAP deletion and measures safety, tolerability, and pharmacokinetics. Participants must have ECOG performance status 0–1 and at least one measurable lesion per RECIST 1.1 after progression on prior therapies. Key exclusions include prior PRMT5 or MAT2A inhibitor treatment, active brain metastases or carcinomatous meningitis, and gastrointestinal conditions likely to affect drug absorption. The trial is conducted at major cancer centers in Beijing, Fuzhou, and Guangzhou using dose-escalation methods typical of first-in-human/early-phase studies to identify safe dose ranges and drug-level profiles.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participants must have histologically confirmed diagnosis of a solid tumor malignancy with homozygous MTAP deletion or MTAP loss detected in tumor tissue by a Sponsor-provided central test or a Sponsor pre-approved local test.
* Participants must have unresectable or metastatic disease not amenable to curative therapies after progression on prior therapies at the time of enrollment.
* Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Participants must have presence of at least one measurable tumor lesion per RECIST 1.1 at baseline.

Exclusion Criteria:

* Participants must not have prior treatment with a Protein arginine methyltransferase 5 (PRMT5) or Methionine adenosyltransferase 2A (MAT2A) inhibitor.
* Participants must not have active brain metastases or carcinomatous meningitis.
* Participants must not have a history of gastrointestinal disease or other gastrointestinal conditions (e.g., uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study treatment or result in inability to swallow oral medications.
* Participants must not have known severe hypersensitivity to study treatment and/or any of its excipients.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Where it's running

• Beijing Cancer hospital
  Beijing, Beijing Municipality, China Recruiting
• Fujian Cancer Hospital
  Fuzhou, Fujian, China Recruiting
• Guangdong Provincial People's Hospital
  Guangzhou, Guangdong, China Recruiting
• Peking University Shenzhen Hospital
  Shenzhen, Guangdong, China Recruiting
• Harbin Medical University Cancer Hospital
  Harbin, Heilongjiang, China Recruiting
• The First Affiliated Hospital of Xinxiang Medical University
  Xinxiang, Henan, China Recruiting

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.