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

Not Applicable

Not yet recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Drug: BMS-986504

• Registration Number: NCT07077434
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-21
• Study First Submitted QC: 2025-07-21
• Study First Posted: 2025-07-22
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-18
• Last Update Posted: 2025-08-22
• Study Start: 2025-10-22
• Primary Completion: 2027-01-19
• Study Completion: 2027-01-19

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 32

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

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BMS-986504 Arm	BMS-986504	-

Primary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration (Cmax) of BMS-986504	Up to approximately Day 64
Time to Reach Maximum Plasma Concentration (Tmax) of BMS-986504	Up to approximately Day 64
Area Under Curve (AUC) of BMS-986504	Up to approximately Day 64
Mean Elimination Half-life (T-HALF) of BMS-986504	Up to approximately Day 64
Apparent Total Body Clearance (CLT/F) of BMS-986504	Up to approximately Day 64
Apparent Volume of Distribution During the Terminal Phase (Vz/F) of BMS-986504	Up to approximately Day 64

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Dose-limiting Toxicities (DLTs)	Up to approximately Day 25
Number of Participants With Treatment-related Adverse Events (AE)	Up to approximately 28 days after last dose of BMS-986504
Number of Participants With all-cause AEs	Up to approximately 28 days after last dose of BMS-986504
Number of Participants With Treatment-related Serious AEs (SAEs)	Up to approximately 28 days after last dose of BMS-986504
Number of Participants With all-cause SAEs	Up to approximately 28 days after last dose of BMS-986504
Number of Participants With AEs Leading to Dose Interruption	Up to approximately 28 days after last dose of BMS-986504
Number of Participants With AEs Leading to Dose Reduction	Up to approximately 28 days after last dose of BMS-986504
Number of Participants With AEs Leading to Treatment Discontinuation	Up to approximately 28 days after last dose of BMS-986504
Number of Participants With AEs Leading to Death	Up to approximately 28 days after last dose of BMS-986504
Number of Participants With Laboratory Abnormalities	Up to approximately 28 days after last dose of BMS-986504

Trial Locations

Locations (12)

Local Institution - 0001; 🇨🇳 Beijing, Beijing, China

Local Institution - 0002; 🇨🇳 Fuzhou, Fujian, China

Local Institution - 0010; 🇨🇳 Guangzhou, Guangdong, China

Local Institution - 0009; 🇨🇳 Shenzhen, Guangdong, China

Local Institution - 0006; 🇨🇳 Harbin, Heilongjiang, China

Local Institution - 0011; 🇨🇳 Xinxiang, Henan, China

Local Institution - 0007; 🇨🇳 Jinan, Shandong, China

Local Institution - 0012; 🇨🇳 Tianjin, Tianjin, China

Local Institution - 0003; 🇯🇵 Yokohama-shi, Asahi-ku, Kanagawa, Japan

Local Institution - 0004; 🇯🇵 Koto-ku, Tokyo, Japan

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