A Phase 1, Open-label Study of BMS-986460 in Participants With Metastatic Castration-resistant Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 15
- 主要终点
- Number of participants with serious adverse events (SAEs)
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability, and preliminary efficacy of BMS-986460 in men with Metastatic Castration-resistant Prostate Cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- Male
- 接受健康志愿者
- 否
入选标准
- •Participant must have histologically or cytologically confirmed adenocarcinoma of the prostate.
- •Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status 0 to
- •Participant must have prostate specific antigen (PSA) of ≥ 2 ng/mL at Screening
- •Participant must have progressed on androgen deprivation therapy (ADT) and at least one prior secondary hormonal therapy approved for castration-resistant prostate cancer (CRPC)
排除标准
- •Participant must not have history of brain metastases.
- •Participant must not have impaired cardiac function or clinically significant cardiac disease.
- •Participant must not have any significant medical condition, including active or uncontrolled infection, psychiatric illness, or the presence of laboratory abnormalities, which places the participant at unacceptable risk or prevent participation in the study based on Investigator assessment.
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Administration of BMS-986460
干预措施: BMS-986460 (Drug)
结局指标
主要结局
Number of participants with serious adverse events (SAEs)
时间窗: Up to 112 weeks
Number of participants with AEs meeting protocol defined dose limiting toxicity (DLT) criteria
时间窗: Up to 28 days
Number of participants with AEs leading to study intervention discontinuation
时间窗: Up to 104 weeks
Number of participants with adverse events (AEs)
时间窗: Up to 112 weeks
Number of participants with serious adverse events (SAEs)
时间窗: Up to 112 weeks
Number of participants with AEs meeting protocol defined dose limiting toxicity (DLT) criteria
时间窗: Up to 28 days
Number of participants with AEs leading to study intervention discontinuation
时间窗: Up to 104 weeks
Number of deaths
时间窗: Up to 108 weeks
次要结局
- Maximum concentration (Cmax)(Up to 13 weeks)
- Number of participants with soft tissue response(Up to 108 weeks)
- Duration of response (DOR)(Up to 108 weeks)
- Time of maximum concentration (Tmax)(Up to 13 weeks)
- Area under the plasma concentration-time curve (AUC)(Up to 13 weeks)
- Number of participants with a confirmed prostate specific antigen decline of ≥ 30% from baseline response rate(Up to 108 weeks)