This is an open-label, multicenter Phase 2 study evaluating BMS-986504 in participants with advanced and/or metastatic solid tumors that have MTAP deletion. The study includes a monotherapy component and a combination component in which BMS-986504 is given with other anti-cancer agents. The trial will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of BMS-986504 alone and in combination regimens.
Part 1 will include parallel enrolment of tumor-specific dose-expansion cohorts evaluating BMS-986504 as monotherapy. Part 2 will include dose-escalation cohorts in which BMS-986504 is given in combination with other anticancer agents. Additional cohorts may be added based on emerging data.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
260
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Local Institution - 0096
San Francisco, California, United States
Local Institution - 0182
Aurora, Colorado, United States
Local Institution - 0122
Tampa, Florida, United States
Local Institution - 0178
Atlanta, Georgia, United States
Local Institution - 0106
Chicago, Illinois, United States
Part 1: Number of participants who achieve Objective Response (OR)
OR is defined as confirmed complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, Response Assessment in Neuro-Oncology (RANO) v2 or Modified RECIST v1.1
Time frame: Up to approximately 2 years
Part 2: Number of participants with adverse events meeting protocol defined dose limiting toxicities (DLTs) criteria
Time frame: Up to approximately 2 years
Part 2: Number of participants with adverse events (AE)
Time frame: Up to approximately 2 years
Part 2: Number of participants with Serious AEs (SAEs)
Time frame: Up to approximately 2 years
Part 2: Number of participants with treatment related AEs
Time frame: Up to approximately 2 years
Part 2: Number of participants with treatment related SAEs
Time frame: Up to approximately 2 years
Part 2: Number of participants with AEs leading to study treatment discontinuation
Time frame: Up to approximately 2 years
Part 2: Number of participants with AEs leading to death
Time frame: Up to approximately 2 years
Part 2: Number of participants with laboratory abnormalities
Time frame: Up to approximately 2 years
Part 1 and 2: Time to objective response (TTOR)
Defined as time from first dose to the date of the first documentation of objective tumor response (CR or PR) by RECIST v1.1 or RANO v2 or Modified RECIST v1.1
Time frame: Up to approximately 2 years
Part 1 and 2: Duration of response (DOR)
Defined as the time between the date of the first documentation of objective tumor response (CR or PR) and the date of disease progression or to death from any cause (whichever occurs first) by RECIST v1.1. or RANO v2 or Modified RECIST v1.1
Time frame: Up to approximately 2 years
Part 1 and 2: Number of participants who achieve disease control (DC)
Best Overall Response (BOR) of confirmed CR, confirmed PR, or stable disease (SD) for at least 4 months after start of treatment) by RECIST v1.1 or RANO v2 or Modified RECIST v1.1
Time frame: Up to approximately 2 years
Part 1: Number of participants with adverse events (AE)
Time frame: Up to approximately 2 years
Part 1: Number of participants with Serious AEs (SAEs)
Time frame: Up to approximately 2 years
Part 1: Number of participants with treatment related AEs
Time frame: Up to approximately 2 years
Part 1: Number of participants with treatment related SAEs
Time frame: Up to approximately 2 years
Part 1: Number of participants with AEs leading to study treatment discontinuation
Time frame: Up to approximately 2 years
Part 1: Number of participants with AEs leading to death
Time frame: Up to approximately 2 years
Part 1: Number of participants with laboratory abnormalities
Time frame: Up to approximately 2 years
Part 2: Number of participants who achieve Objective Response (OR)
Time frame: Up to approximately 2 years
Part 1 and 2: Number of participants who achieved clinical benefit (CB)
CB defined as BOR of confirmed CR, confirmed PR, or SD for at least 4 months after start of treatment by RECIST v1.1 or RANO v2
Time frame: Up to approximately 2 years
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Local Institution - 0143
Baltimore, Maryland, United States
Local Institution - 0124
Boston, Massachusetts, United States
Local Institution - 0119
Ann Arbor, Michigan, United States
Local Institution - 0129
Rochester, Minnesota, United States
Local Institution - 0174
Rochester, Minnesota, United States
...and 45 more locations