A Phase 1/1b Open-label Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors
Summary
This purpose of this study is to determine if experimental treatment with BMS-986488, alone, or in combinations is safe, tolerable, and has anti-cancer activity in patients with advanced malignant tumors.
Arms & interventions
- DrugBMS-986488
Specified dose on specified days
- DrugAdagrasib
Specified dose on specified days
- DrugCetuximab
Specified dose on specified days
- DrugNivolumab
Specified dose on specified days
Outcome measures
Primary
Number of participants with Adverse Events (AEs)
Time frame: Until the end of the Safety Follow-up period (up to approximately 100 days after last dose)
Number of participants with Serious AEs (SAEs)
Time frame: Until the end of the Safety Follow-up period (up to approximately 100 days after last dose)
Number of participants with AEs meeting protocol-defined Dose-Limiting Toxicity (DLT) criteria
Time frame: From first dose of study treatment until end of cycle 1 (1 Cycle = 28 Days)
Number of participants with AEs leading to discontinuation
Time frame: Until the end of the Safety Follow-up period (up to approximately 100 days after last dose)
Number of deaths
Time frame: From time of informed consent up to 52 weeks after end of treatment visit
Secondary
Maximum observed plasma concentration (Cmax)
Time frame: Until Cycle 4, Day 1 (1 Cycle = 28 Days)
Time of maximum observed concentration (Tmax)
Time frame: Until Cycle 4, Day 1 (1 Cycle = 28 Days)
Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
Time frame: Until Cycle 4, Day 1 (1 Cycle = 28 Days)
Objective response rate (ORR)
Time frame: From time of informed consent up to 52 weeks after end of treatment visit
Disease control rate (DCR)
Time frame: From time of informed consent up to 52 weeks after end of treatment visit
Duration of response (DOR)
Time frame: From time of informed consent up to 52 weeks after end of treatment visit
Eligibility criteria
Study locations (4)
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
Local Institution - 0020
Allentown, Pennsylvania, 18103
The West Clinic, PLLC dba West Cancer Center
Germantown, Tennessee, 38138
Local Institution - 0025
Dallas, Texas, 75390