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

Recruiting now · Phase 1

Conditions studied: Advanced Solid Tumors

In brief

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

Key facts

Study ID

NCT07077434

Run by

Bristol-Myers Squibb

People needed

32

Starts

2025-10-15

Expected to finish

2027-01-19

Last updated by the study team

2026-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

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

Full record on ClinicalTrials.gov

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