A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors
- Conditions
- Advanced Solid TumorAdvanced Breast CancerAdvanced Ovarian Cancer
- Interventions
- Registration Number
- NCT06997029
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to assess BMS-986500 as monotherapy in advanced solid tumors and as combination therapy in CDK4/6 inhibitor pre-treated advanced breast cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 234
- Participants must be ≥ 18 years of age.
- Participants must have histologically confirmed diagnosis of a locally advanced, unresectable, or metastatic solid tumor malignancy.
- Participants must have a measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Participants must have a stable Eastern Cooperative Oncology Group Performance Status of 0 or 1.
- For Part 2A only, participants must have CCNE1-amplified ovarian cancer
- Participants must not have an active brain metastasis.
- Participants must not have impaired cardiac function or clinically significant cardiac disease.
- Participants must not have bleeding disorder or any history of clinically significant bleeding within the prior 3 months.
- Participants must not have Grade ≥ 2 peripheral neuropathy.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1A Monotherapy Dose Escalation BMS-986500 - Part 1B Combination Dose Escalation BMS-986500 - Part 1B Combination Dose Escalation Palbociclib - Part 1C Monotherapy Pharmacodynamic (PD) Sub-study BMS-986500 - Part 2A Monotherapy Dose Expansion BMS-986500 - Part 1B Combination Dose Escalation Fulvestrant - Part 2B Combination Dose Expansion BMS-986500 - Part 2B Combination Dose Expansion Palbociclib - Part 2B Combination Dose Expansion Fulvestrant -
- Primary Outcome Measures
Name Time Method Number of Participants With Dose Limiting Toxicities (DLTs) Up to Day 28 From Last Dose Number of Participants With Adverse Events (AEs) Up to Day 28 From Last Dose Number of Participants With Serious Adverse Events (SAEs) Up to Day 28 From Last Dose Number of Participants With AEs Leading to Discontinuation Up to Day 28 From Last Dose Number of Participants With TEAEs Leading to Death Up to Day 28 From Last Dose
- Secondary Outcome Measures
Name Time Method Maximum Observed Serum Concentration (Cmax) of BMS-986500 Up to Approximately 3 Months Time of Maximum Observed Serum Concentration (Tmax) of BMS-986500 Up to Approximately 3 Months Area Under the Concentration-time Curve Within a Dosing Interval (AUC(TAU)) of BMS-986500 Up to Approximately 3 Months
Trial Locations
- Locations (13)
Local Institution - 0001
🇺🇸Birmingham, Alabama, United States
Local Institution - 0003
🇺🇸Fullerton, California, United States
Local Institution - 0013
🇺🇸Greenbrae, California, United States
Local Institution - 0009
🇺🇸La Jolla, California, United States
Local Institution - 0010
🇺🇸Newport Beach, California, United States
Local Institution - 0008
🇺🇸Aurora, Colorado, United States
Local Institution - 0006
🇺🇸Boston, Massachusetts, United States
Local Institution - 0004
🇺🇸Saint Louis, Missouri, United States
Local Institution - 0002
🇺🇸Lebanon, New Hampshire, United States
Local Institution - 0014
🇺🇸Buffalo, New York, United States
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