A Phase 1/2 First-in-human Study of BMS-986288 Alone and in Combination with Nivolumab in Advanced Malignant Tumors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 16
- 主要终点
- For Part 1, 2A, 2B: Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), AEs meeting protocol-defined Dose Limiting Toxicities (DLT) Criteria, AEs leading to discontinuation, death and laboratory abnormalities
研究概览
简要总结
For Part 1, 2A, 2B: To characterize the safety, tolerability, and Dose-Limiting Toxicities (DLTs) and to determine the Maximum Tolerated Dose (MTD)/ Recommended Phase 2 Dose (RP2D) of BMS-986288 administered as monotherapy and in combination with nivolumab in participants with select advanced solid tumors. For Part 2C: To compare the efficacy of BMS-986288 in combination with nivolumab vs regorafenib in the 3L/4L MSS CRC setting.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Histologic or cytologic confirmation of select solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease and have at least 1 lesion accessible for biopsy
- •Eastern Cooperative Oncology Group Performance Status of 0 or 1
- •Participants must have received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to select solid tumor histologies
排除标准
- •Participants with active, known or suspected autoimmune disease
- •Participants with other active malignancy requiring concurrent intervention
- •Participants with primary CNS malignancies or tumors with CNS metastasis as the only site of disease, will be excluded
结局指标
主要结局
For Part 1, 2A, 2B: Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), AEs meeting protocol-defined Dose Limiting Toxicities (DLT) Criteria, AEs leading to discontinuation, death and laboratory abnormalities
For Part 1, 2A, 2B: Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), AEs meeting protocol-defined Dose Limiting Toxicities (DLT) Criteria, AEs leading to discontinuation, death and laboratory abnormalities
For Part 2C: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by BICR
For Part 2C: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by BICR
次要结局
- For Part 1, 2A, 2B: Maximum Observed Concentration (Cmax) of BMS-986288
- For Part 1, 2A, 2B: Time of Maximum Observed Concentration (Tmax) of BMS-986288
- For Part 1, 2A, 2B: Area Under the Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration AUC(0-T) of BMS-986288
- For Part 1, 2A, 2B: Area Under the Concentration-Time Curve in one Dosing Interval AUC(TAU) of BMS-986288
- For Part 1, 2A, 2B: Observed Concentration at the end of a Dosing Interval (Ctau) of BMS- 986288
- For Part 1, 2A, 2B: Trough Observed Concentrations (Ctrough) of BMS-986288
- For Part 1, 2A, 2B: Total Body Clearance (CLT) of BMS-986288
- For Part 1, 2A, 2B: Average Concentration Over a Dosing Interval at Steady State (Cavgss) of BMS-986288
- For Part 1, 2A, 2B: Accumulation Index (AI) of BMS-986288
- For Part 1, 2A, 2B: Terminal Half-Life (T-HALF) of BMS-986288
- For Part 1, 2A, 2B: Objective Response Rate (ORR) of Participants
- For Part 1, 2A, 2B: Duration of Response (DOR) of Participants
- For Part 1, 2A, 2B: Progression-Free Survival (PFS) of Participants
- For Part 1, 2A, 2B: Time to Response (TTR) of Participants
- For Part 2C: Objective Response Rate (ORR) by RECIST V1.1 by BICR
- For Part 2C: Duration of Response (DOR) by RECIST V1.1 by BICR
- For Part 2C: Progression-Free Survival (PFS) by RECIST V1.1 by BICR
- For Part 2C: Overall Survival (OS) by RECIST V1.1 by BICR
- For Part 2C: Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), AEs meeting protocol-defined Dose Limiting Toxicities (DLT) Criteria, AEs leading to discontinuation and death.
研究者
GSM-CT
Scientific
Bristol Myers Squibb International Corporation