A First-in-Human Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)
Not Applicable
Not yet recruiting
- Conditions
- Renal Cell Carcinoma
- Interventions
- Drug: BMS-986506
- Registration Number
- NCT07195682
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
This is a first-in-human study of BMS-986506 in participants with advanced Clear Cell Renal Cell Carcinoma (ccRCC). The primary objective of this study is to find out if BMS-986506 is safe and can be tolerated when taken alone by participants with ccRCC.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 125
Inclusion Criteria
- Participants must have histologically confirmed diagnosis of locally advanced or metastatic ccRCC.
- For part 1: Participants must have already had at least two different treatment plans in the past, including immunotherapy and a targeted therapy.
- For part 2: Participants must have had at least one standard treatment plan that included both a PD-1/L1 inhibitor and a VEGF-TKI (either together or one after the other).
- Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Exclusion Criteria
- Participants with Inability to administer and/or tolerate oral medication without chewing, breaking, crushing, or otherwise altering the product dosage form.
- For Part 2A: Participants who have received more than 3 prior systemic regimens for locally advanced or metastatic ccRCC including prior treatment with HIF2a inhibitors.
- Participants who have hypoxia as defined by a pulse oximeter reading < 92% at rest or requires intermittent or chronic supplemental oxygen.
- Participants who have received colony-stimulating factors (eg, G-CSF, GM-CSF or recombinant EPO) within 28 days prior to the first dose of study intervention.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BMS-986506: Part 1A BMS-986506 - BMS-986506: Part 2B BMS-986506 - BMS-986506: Part 2A BMS-986506 -
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events (AEs) Up to approximately 2 years from first dose of BMS-986506 Number of Participants With Serious Adverse Events (SAEs) Up to approximately 2 years from first dose of BMS-986506 Number of Participants With AEs Meeting Protocol Defined Dose-limiting Toxicity (DLT) Criteria Up to approximately Day 28 Number of Participants With AEs Leading to Discontinuation Up to approximately 2 years from first dose of BMS-986506 Number of Participants With AEs Leading to Deaths as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v 5.0 Up to approximately 2 years from first dose of BMS-986506
- Secondary Outcome Measures
Name Time Method Maximum Observed Plasma Concentration (Cmax) of BMS-986506 Up to approximately Day 85 Time of Maximum Observed Plasma Concentration (Tmax) of BMS-986506 Up to approximately Day 112 Area Under the Concentration-time Curve Within a Dosing Interval (AUC-TAU) of BMS-986506 Up to approximately Day 112 Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) Up to approximately 3 years from first dose of BMS-986506 Disease Control Rate (DCR) as Assessed by RECIST v1.1 Up to approximately 3 years from first dose of BMS-986506 Duration of Response (DOR) as Assessed by RECIST v1.1 Up to approximately 3 years from first dose of BMS-986506 Time to Response (TTR) as Assessed by RECIST v1.1 Up to approximately 3 years from first dose of BMS-986506
Trial Locations
- Locations (8)
Local Institution - 0006
🇺🇸Boston, Massachusetts, United States
Local Institution - 0002
🇺🇸Philadelphia, Pennsylvania, United States
Local Institution - 0026
🇺🇸Nashville, Tennessee, United States
Local Institution - 0001
🇺🇸San Antonio, Texas, United States
Local Institution - 0021
🇨🇦Calgary, Alberta, Canada
Local Institution - 0008
🇫🇷Villejuif, Val-de-Marne, France
Local Institution - 0015
🇪🇸Córdoba, Andalusia, Spain
Local Institution - 0018
🇪🇸Barcelona, Barcelona [Barcelona], Spain
Local Institution - 0006🇺🇸Boston, Massachusetts, United StatesSite 0006Contact