A Phase 1/2a, Open-label, Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BMS-986507 (BL-B01D1) Combinations in Adult Participants With Advanced Solid Tumors
Summary
The purpose of this study is to evaluate the safety, tolerability, drug levels, and preliminary efficacy of BMS-986507 combinations in adult participants with advanced solid tumors.
Arms & interventions
- DrugBMS-986507
Specified dose on specified days
- DrugOsimertinib
Specified dose on specified days
- DrugPembrolizumab
Specified dose on specified days
- DrugNivolumab
Specified dose on specified days
- DrugPumitamig
Specified dose on specified days
Outcome measures
Primary
Number of participants with adverse events (AEs)
Time frame: Up to 3 years
Number of participants with serious adverse events (SAEs)
Time frame: Up to 3 years
Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) critera
Time frame: Up to 3 years
Number of participants with AEs leading to discontinuation
Time frame: Up to 3 years
Number of participants with AEs leading to death
Time frame: Up to 3 years
Number of DLTs that occur during the DLT evaluation period
Time frame: Up to 3 weeks
Secondary
Maximum observed serum concentration (Cmax)
Time frame: Up to 3 years
Time of maximum observed concentration (Tmax)
Time frame: Up to 3 years
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Time frame: Up to 3 years
Area under the serum concentration-time curve within a dosing interval (AUC(TAU))
Time frame: Up to 3 years
Objective response rate (ORR)
Time frame: Up to 2 year
Eligibility criteria
Study locations (14)
University of Alabama at Birmingham
Birmingham, Alabama, 35294
University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami, Florida, 33136
Local Institution - 0125
Maywood, Illinois, 60153
Local Institution - 0065
Iowa City, Iowa, 52242
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
Cleveland Clinic
Cleveland, Ohio, 44195
Local Institution - 0102
Columbus, Ohio, 43212
Local Institution - 0134
Portland, Oregon, 97225
Local Institution - 0052
Portland, Oregon, 97239
Local Institution - 0090
Portland, Oregon, 97239
Local Institution - 0014
Pittsburgh, Pennsylvania, 15232
Local Institution - 0103
Knoxville, Tennessee, 37920
NEXT Oncology - Irving
Irving, Texas, 75039
Swedish Medical Center
Seattle, Washington, 98104