NCT06476808招募中1 期
A Phase 1/1b First-in-human Study of BMS-986463 in Advanced Malignant Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 30
- 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 evaluate the safety, tolerability, and efficacy of escalating doses of BMS-986463 in participants with select advanced malignant 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 must have an Eastern Cooperative Oncology Group Performance Status of 0 or
- •Participants must have at least 1 lesion accessible for biopsy in addition to the target lesion, from which a fresh pre treatment biopsy must be obtained.
- •Participants must have an unresectable/metastatic carcinoma.
排除标准
- •Participants must not have Leptomeningeal metastases.
- •Participants must not have concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment.
- •Participants must not have had any prior radiation therapy within 2 weeks prior to start of study treatment.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Arm 2: Dose Expansion
Experimental
干预措施: BMS-986463 (Drug)
Arm 1: Dose Escalation
Experimental
干预措施: BMS-986463 (Drug)
结局指标
主要结局
Number of participants with serious adverse events (SAEs)
时间窗: Up to 108 weeks
Number of participants with adverse events (AEs)
时间窗: Up to 108 weeks
Number of participants with AEs leading to discontinuation
时间窗: Up to 108 weeks
Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) criteria
时间窗: Up to 108 weeks
Number of participants with AEs leading to death
时间窗: Up to 108 weeks
次要结局
- Maximum observed concentration (Cmax)(Up to 104 weeks)
- Time of maximum observed concentration (Tmax)(Up to 104 weeks)
- Objective response rate (ORR)(Up to 104 weeks)
- Disease control rate (DCR)(Up to 104 weeks)
- Duration of response (DOR)(Up to 104 weeks)
- Area under the concentration-time curve (AUC)(Up to 104 weeks)
研究者
研究点 (30)
Loading locations...
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