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A Study to Assess Safety, Tolerability and Drug Levels of BMS-986504 in Participants With Advanced Solid Tumors

A Phase 1 Open-Label, Multi-Center Study to Evaluate Pharmacokinetics, Safety and Tolerability of BMS-986504 in Japanese and Chinese Participants with Advanced Solid Tumors with Homozygous MTAP Deletion

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2031250413
Enrollment
12
Registered
2025-10-06
Start date
2025-10-22
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumors

Interventions

Single arm, BMS-986504 Specified dose on specified days

Sponsors

Hreiki Joseph
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Participants must have histologically confirmed diagnosis of a solid tumor malignancy with homozygous deletion of the MTAP gene detected in tumor tissue. 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

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.

Design outcomes

Primary

MeasureTime frame
Maximum Plasma Concentration (Cmax) of BMS-986504

Secondary

MeasureTime frame
Number of Participants With Dose-limiting Toxicities (DLTs)

Countries

China, Japan

Contacts

Public ContactJoseph Hreiki

Bristol-Myers Squibb

MG-JP-RCO-JRCT@bms.com+81-120-093-507

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jun 11, 2026