A Phase 1/2a, First-in-human, Open-label Study of BMS-986517 as Monotherapy in Adult Participants With Advanced Solid Tumors
Summary
A phase 1/2a, open-label, first-in-human study mainly aimed to evaluate the safety and tolerability of BMS-986517 in participants with solid tumors
Arms & interventions
- DrugBMS-986517
Specified dose on specified days
Outcome measures
Primary
Number of Participants with Adverse Events (AE)
Time frame: Up to approximately 2 years
Number of Participants with Serious Adverse Events (SAE)
Time frame: Up to approximately 2 years
Number of Participants with AEs meeting protocol-defined Dose-limiting Toxicities (DLTs) criteria
For part 1 only
Time frame: Up to Day 21
Number of Participants with AEs Leading to Discontinuation
Time frame: Up to approximately 2 years
Number of Participants with AEs Leading to Deaths
Time frame: Up to approximately 2 years
Secondary
Objective Response Rate (ORR) Assessed by RECIST v1.1 per investigator assessment
Time frame: Up to approximately 3 years
Duration of Response (DOR) Assessed by RECIST v1.1 per investigator assessment
Time frame: Up to approximately 3 years
Maximum Plasma Concentration (Cmax)
Time frame: Up to approximately 2 years
Time to Reach Maximum Plasma Concentration (Tmax)
Time frame: Up to approximately 2 years
Area Under Curve (AUC)
Time frame: Up to approximately 2 years
Total anti-drug antibodies (ADAs)
Time frame: Up to approximately 2 Years
Eligibility criteria
Study locations (9)
Local Institution - 0033
Irvine, California, 92612
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
University of California, Irvine (UCI) Health - UC Irvine Medical Center
Orange, California, 92868-3201
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Sanford Cancer Center
Sioux Falls, South Dakota, 57104
START - Dallas Fort Worth
Fort Worth, Texas, 76104
START San Antonio
San Antonio, Texas, 78229
START Mountain Region
West Valley City, Utah, 84119
Fred Hutchinson Cancer Center
Seattle, Washington, 98109