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