A Phase 1/2 First-in-Human Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) - Part 1 A and 1 B

时间窗: From first dose until 100 days after last dose of study therapy (up to approximately 38 weeks)

Adverse Events (AEs): Adverse events are any unwanted or harmful medical occurrences in a participant who receives a study drug or intervention. These events may or may not be related to the treatment. Serious Adverse Events (SAEs): Serious adverse events are adverse events that result in death, are life-threatening, require hospitalization or prolong existing hospitalization, cause significant disability or incapacity, or result in a birth defect.

Number of Participants With Adverse Events (AEs) Meeting Protocol-Defined Dose-Limiting Toxicity (DLT) Criteria - Part 1 A and 1 B

时间窗: From first dose until 5 weeks after first dose of study medicine (up to approximately 5 weeks)

Dose-limiting toxicities (DLTs) were defined by the incidence, intensity, and duration of adverse events (AEs) possibly related to study treatment during the 5-week (35-day) DLT evaluation period for both BMS-986249 monotherapy and combination therapy. Participants who received at least 2 doses and completed or discontinued due to a DLT within this period were considered DLT-evaluable. Those who withdrew or received less than 2 doses for reasons other than a DLT were not DLT-evaluable and could be replaced. Any drug-related AE meeting DLT criteria resulted in discontinuation of study treatment. DLTs guided dose escalation and helped define the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D).

Number of Participants Who Died - Part 1 A and 1 B

时间窗: From enrollment until the date of death from any cause (up to approximately 83 months)

Number of Participants who Died

Number of Participants With Shifts From Baseline in Laboratory Tests Results - Part 1 A and 1 B

时间窗: From first dose until 100 days after last dose of study therapy (up to approximately 38 weeks)

Number of Participants with Shifts from Baseline in Laboratory Tests

Number of Participants With Treatment-Related Grade 3-5 Adverse Events (AEs) Within 24 Weeks - Part 2 A Arms C, D and F, and Part 2 B

时间窗: From first dose until 24 weeks after first dose (up to approximately 24 weeks)

Adverse Events (AEs): Adverse events are any unwanted or harmful medical occurrences in a participant who receives a study drug or intervention. These events may or may not be related to the treatment. Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; no intervention needed. Grade 2: Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate activities. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling. Grade 4: Life-threatening consequences; urgent intervention required. Grade 5: Death related to the adverse event.

Objective Response Rate (ORR) as Assessed by Investigator - Part 2 A Arm C and F

时间窗: From randomization until progression or death from any cause (up to approximately 83 months)

Objective response rate (ORR) is defined as the percent of participants whose best overall response (BOR) is either complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must also have reduction in the short axis to \<10mm. Partial Response (PR): At least a30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.