A Phase 1 First-in-human Study of BMS-986500 as Monotherapy in Advanced Solid Tumors and as Combination Therapy in CDK4/6 Inhibitor Pre-treated Advanced Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 234
- 试验地点
- 31
- 主要终点
- Number of Participants With Dose Limiting Toxicities (DLTs)
研究概览
简要总结
The purpose of this study is to assess BMS-986500 as monotherapy in advanced solid tumors and as combination therapy in CDK4/6 inhibitor pre-treated advanced breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 must be ≥ 18 years of age.
- •Participants must have histologically confirmed diagnosis of a locally advanced, unresectable, or metastatic solid tumor malignancy.
- •Participants must have a measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- •Participants must have a stable Eastern Cooperative Oncology Group Performance Status of 0 or
- •For Part 2A only, participants must have CCNE1-amplified ovarian cancer
排除标准
- •Participants must not have an active brain metastasis.
- •Participants must not have impaired cardiac function or clinically significant cardiac disease.
- •Participants must not have bleeding disorder or any history of clinically significant bleeding within the prior 3 months.
- •Participants must not have Grade ≥ 2 peripheral neuropathy.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Part 2B Combination Dose Expansion
干预措施: BMS-986500 (Drug)
Part 1B Combination Dose Escalation
干预措施: Palbociclib (Drug)
Part 1C Monotherapy Pharmacodynamic (PD) Sub-study
干预措施: BMS-986500 (Drug)
Part 2A Monotherapy Dose Expansion
干预措施: BMS-986500 (Drug)
Part 2B Combination Dose Expansion
干预措施: Fulvestrant (Drug)
Part 1B Combination Dose Escalation
干预措施: Fulvestrant (Drug)
Part 2B Combination Dose Expansion
干预措施: Palbociclib (Drug)
Part 1A Monotherapy Dose Escalation
干预措施: BMS-986500 (Drug)
Part 1B Combination Dose Escalation
干预措施: BMS-986500 (Drug)
结局指标
主要结局
Number of Participants With Dose Limiting Toxicities (DLTs)
时间窗: Up to Day 28 From Last Dose
Number of Participants With Adverse Events (AEs)
时间窗: Up to Day 28 From Last Dose
Number of Participants With Serious Adverse Events (SAEs)
时间窗: Up to Day 28 From Last Dose
Number of Participants With AEs Leading to Discontinuation
时间窗: Up to Day 28 From Last Dose
Number of Participants With TEAEs Leading to Death
时间窗: Up to Day 28 From Last Dose
次要结局
- Maximum Observed Serum Concentration (Cmax) of BMS-986500(Up to Approximately 2 Years)
- Time of Maximum Observed Serum Concentration (Tmax) of BMS-986500(Up to Approximately 2 Years)
- Area Under the Concentration-time Curve Within a Dosing Interval (AUC(TAU)) of BMS-986500(Up to Approximately 2 Years)