A Phase 1 Study of BMS-986416 Alone and in Combination With Nivolumab in Select Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 19
- 主要终点
- Incidence of AEs leading to discontinuation
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, drug effects, drug levels and preliminary antitumor activity of BMS-986416 when administered alone and in combination with Nivolumab in participants with select advanced solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with histologically or cytologically confirmed locally advanced unresectable, metastatic, or recurrent select solid tumor
- •Eligible tumor types Non-small cell lung cancer (NSCLC), Urothelial carcinoma (UC), Squamous cell carcinoma of the head and neck (SCCHN), Hepatocellular carcinoma (HCC), Microsatellite-stable colorectal carcinoma (MSS CRC), or Pancreatic ductal adenocarcinoma (PDAC)
- •Resistant/refractory to or intolerant of existing standard therapies known to provide clinical benefit
- •Measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1)
- •Disease amenable to serial biopsy
排除标准
- •Uncontrolled or significant cardiovascular disease
- •Known connective tissue disease such as Marfan, Ehlers-Danlos, or Loeys-Dietz syndrome
- •Medical requirement for chronic anticoagulant or antiplatelet agents (except low-dose aspirin, which is permitted)
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Part 1A: Monotherapy (BMS-986416)
干预措施: BMS-986416 (Drug)
Part 1B: Combination Therapy (BMS-986416 + Nivolumab)
干预措施: BMS-986416 (Drug)
Part 1B: Combination Therapy (BMS-986416 + Nivolumab)
干预措施: Nivolumab (Drug)
结局指标
主要结局
Incidence of AEs leading to discontinuation
时间窗: Up to 100 days after the last treatment of study intervention(s)
Incidence of AEs leading to death
时间窗: Up to 100 days after the last treatment of study intervention(s)
Protocol-defined maximum tolerated dose (MTD) or maximum administered dose (MAAD)
时间窗: Up to 100 days after the last treatment of study intervention(s)
Incidence of Adverse Events (AEs)
时间窗: Up to 100 days after the last treatment of study intervention(s)
Incidence of Serious Adverse Events (SAEs)
时间窗: Up to 100 days after the last treatment of study intervention(s)
Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
时间窗: Up to 100 days after the last treatment of study intervention(s)
次要结局
- Time of maximum observed serum concentration (Tmax) of BMS-986416(Up to 100 days after the last treatment of study intervention(s))
- Maximum observed serum concentration (Cmax) of BMS-986416(Up to 100 days after the last treatment of study intervention(s))
- Trough observed serum concentration (Ctrough) of BMS-986416(Up to 100 days after the last treatment of study intervention(s))
- Duration of Response (DOR) using RECIST 1.1 per Investigator assessment(Up to 2 years)
- Overall Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) per Investigator assessment(Up to 2 years)
- Incidence of clinically significant changes in ECG parameters: QTcF(Up to 100 days after the last treatment of study intervention(s))