A Phase 1/2a, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of BMS-986523 As Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Malignancies
Summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of BMS-986523 alone and in combination with anti-cancer agents in participants with advanced solid malignancies
Arms & interventions
- DrugBMS-986523
Specified dose on specified days
- DrugGemcitabine
Specified dose on specified days
- DrugNab-Paclitaxel
Specified dose on specified days
- DrugCetuximab
Specified dose on specified days
- DrugPembrolizumab
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) criteria
Time frame: Up to 3 years
Number of participants with AEs leading to discontinuation
Time frame: Up to 3 years
Number of deaths
Time frame: Up to 3 years
Secondary
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the investigator.
Time frame: Up to 3 years
Duration of response (DOR) per RECIST v1.1 as assessed by the investigator.
Time frame: Up to 3 years
Maximum observed plasma concentration (Cmax)
Time frame: Up to 3 years
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to 3 years
Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
Time frame: Up to 3 years
Eligibility criteria
Study locations (4)
Johns Hopkins Hospital
Baltimore, Maryland, 21287
NEXT Oncology
San Antonio, Texas, 78229
START Mountain Region
West Valley City, Utah, 84119
NEXT Virginia
Fairfax, Virginia, 22031