RecruitingPhase 1NCT07077434

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


Sponsor

Bristol-Myers Squibb

Enrollment

32 participants

Start Date

Oct 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the safety, tolerability and drug levels of BMS-986504 in participants with advanced solid tumors.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria4

  • 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.

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Interventions

DRUGBMS-986504

Specified dose on specified days


Locations(12)

Beijing Cancer hospital

Beijing, Beijing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Local Institution - 0006

Harbin, Heilongjiang, China

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China

Shandong Cancer Hospital

Jinan, Shandong, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

Kanagawa cancer center

Yokohama, Kanagawa, Japan

Shizuoka Cancer Center

Sunto-gun, Shizuoka, Japan

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

The Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, Japan

View Full Details on ClinicalTrials.gov

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NCT07077434


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