NCT07325136招募中1 期
A Phase 1/2 Study of BMS-986525 as Monotherapy and in Combination Therapy in Participants With Relapsed/Refractory Small Cell Lung Cancer
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
- 17
- 主要终点
- Number of participants with adverse events (AEs)
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of BMS-986525 alone and in combination with Pumitamig in participants with Relapsed/Refractory Small Cell Lung 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 have histologically or cytologically documented relapsed/refractory small cell lung cancer (R/R-SCLC).
- •Participants must have received at least 1 platinum-based chemotherapy regimen as per locally approved drug labels and institutional guidelines.
- •In countries where standard of care first line systemic treatment includes platinum containing chemotherapy in combination with anti-PD-(L)1 therapy, it is required that participants have progressed on, are ineligible for or not have access to an anti-PD- (L)1 therapy.
排除标准
- •Participants must not have any untreated CNS metastases.
- •Participants must not have an active, known or suspected autoimmune disease.
- •Participants must not have had a prior organ or tissue allograft.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Part 2A: BMS-986525 Monotherapy Dose Expansion
Experimental
干预措施: BMS-986525 (Drug)
Part 1A: BMS-986525 Monotherapy Dose Escalation
Experimental
干预措施: BMS-986525 (Drug)
Part 2B: BMS-986525 Combination with Pumitamig Dose Expansion
Experimental
干预措施: BMS-986525 (Drug)
Part 2B: BMS-986525 Combination with Pumitamig Dose Expansion
Experimental
干预措施: Pumitamig (Drug)
Part 1B: BMS-986525 Combination with Pumitamig Dose Escalation
Experimental
干预措施: BMS-986525 (Drug)
Part 1B: BMS-986525 Combination with Pumitamig Dose Escalation
Experimental
干预措施: Pumitamig (Drug)
结局指标
主要结局
Number of participants with adverse events (AEs)
时间窗: Up to approximately 2 years
Number of participants with serious adverse events (SAEs)
时间窗: Up to approximately 2 years
Number of participants with AEs meeting dose-limiting toxicity (DLT) criteria
时间窗: Up to 21 days
Number of participants with AEs leading to discontinuation
时间窗: Up to approximately 2 years
Number of participants with AEs leading to death
时间窗: Up to approximately 2 years
次要结局
- Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumor Version 1.1 (RECIST v1.1) by investigator assessment(Up to approximately 3 years)
- Maximum observed concentration within a dosing interval (Cmax)(Up to approximately 2 years)
- Area under the concentration-time curve within a dosing interval (AUC(TAU))(Up to approximately 2 years)
- Time of maximum observed plasma concentration within a dosing interval (Tmax)(Up to approximately 2 years)
研究者
研究点 (17)
Loading locations...
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