NCT07226427招募中1 期
A Phase 1, First-in-Human Study of MEN2501, a KIF18A Inhibitor, as Monotherapy in Participants With Platinum-Resistant Ovarian 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
- 100
- 试验地点
- 16
- 主要终点
- Part A Only: Number of Participants with Dose-limiting Toxicities (DLTs)
研究概览
简要总结
This is a first-in-human, open-label, dose-escalation, dose-optimization trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of MEN2501 monotherapy in adult participants with platinum-resistant ovarian cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants must have a histopathologically confirmed diagnosis of high-grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
排除标准
- •Participants with primary platinum-refractory disease.
- •Note: Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Part A: MEN2501 Dose Escalation
Experimental
干预措施: MEN2501 (Drug)
Part B: MEN2501 Dose Expansion & Optimization
Experimental
干预措施: MEN2501 (Drug)
结局指标
主要结局
Part A Only: Number of Participants with Dose-limiting Toxicities (DLTs)
时间窗: Cycle 1 (28 days/cycle)
Part B Only: Recommended Phase 2 Dose (RP2D) of MEN2501
时间窗: Up to approximately 6 months
次要结局
- Number of Participants with Treatment-emergent Adverse Events(Up to approximately 7 months)
- Overall Response Rate(Up to approximately 7 months)
- Duration of Objective Response(Up to approximately 7 months)
- Clinical Benefit Rate(Up to approximately 7 months)
- Progression-free Survival(Up to approximately 12 months)
- Overall Survival(Up to approximately 12 months)
- Time To Response(Up to approximately 7 months)
- Area Under the Plasma Concentration-time Curve (AUC) of MEN2501(Up to approximately 6 months)
研究者
研究点 (16)
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