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Clinical Trials in China / NCT07077434
Recruiting Phase 1

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

NCT07077434 · tracked via the Priya Life Science China tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 1
Started
2025-10-15
Last updated
2026-06-03

Condition(s) studied

Advanced Solid Tumors

Investigational drug(s) / intervention(s)

BMS-986504 →

BMS-986504: Specified dose on specified days

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (12)

FacilityCityRegionStatus
Beijing Cancer hospital Beijing Beijing Municipality Recruiting
Fujian Cancer Hospital Fuzhou Fujian Recruiting
Guangdong Provincial People's Hospital Guangzhou Guangdong Recruiting
Peking University Shenzhen Hospital Shenzhen Guangdong Recruiting
Harbin Medical University Cancer Hospital Harbin Heilongjiang Recruiting
The First Affiliated Hospital of Xinxiang Medical University Xinxiang Henan Recruiting
Shandong Cancer Hospital Jinan Shandong Recruiting
Tianjin Medical University Cancer Institute & Hospital Tianjin Tianjin Municipality Recruiting
Kanagawa cancer center Yokohama Kanagawa Recruiting
Shizuoka Cancer Center Sunto-gun Shizuoka Recruiting
National Cancer Center Hospital Chuo-ku Tokyo Recruiting
The Cancer Institute Hospital of JFCR Koto-ku Tokyo Recruiting

More Bristol-Myers Squibb trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07077434 on ClinicalTrials.gov ↗ ← All trials in China