A Phase 1/1b Open-label, Multi-center Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)
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.
Arms & interventions
- DrugBMS-986506
Specified dose on specified days
Outcome measures
Primary
Number of Participants With Adverse Events (AEs)
Time frame: Up to approximately 2 years from first dose of BMS-986506
Number of Participants With Serious Adverse Events (SAEs)
Time frame: Up to approximately 2 years from first dose of BMS-986506
Number of Participants With AEs Meeting Protocol Defined Dose-limiting Toxicity (DLT) Criteria
Time frame: Up to approximately Day 28
Number of Participants With AEs Leading to Discontinuation
Time frame: 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
Time frame: Up to approximately 2 years from first dose of BMS-986506
Secondary
Maximum Observed Plasma Concentration (Cmax) of BMS-986506
Time frame: Up to approximately Day 85
Time of Maximum Observed Plasma Concentration (Tmax) of BMS-986506
Time frame: Up to approximately Day 112
Area Under the Concentration-time Curve Within a Dosing Interval (AUC-TAU) of BMS-986506
Time frame: Up to approximately Day 112
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Time frame: Up to approximately 3 years from first dose of BMS-986506
Disease Control Rate (DCR) as Assessed by RECIST v1.1
Time frame: Up to approximately 3 years from first dose of BMS-986506
Duration of Response (DOR) as Assessed by RECIST v1.1
Time frame: Up to approximately 3 years from first dose of BMS-986506
Time to Response (TTR) as Assessed by RECIST v1.1
Time frame: Up to approximately 3 years from first dose of BMS-986506
Eligibility criteria
Study locations (5)
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
SCRI Oncology Partners
Nashville, Tennessee, 37203
START San Antonio
San Antonio, Texas, 78229