NCT07545356尚未招募1 期
A Phase 1 Dose-Finding and Dose Optimization-Expansion Study of KIVU-305 in Participants With Locally Advanced or Metastatic Solid Tumors
Kivu Bioscience Inc.3 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2026年6月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 76
- 试验地点
- 3
- 主要终点
- To determine Maximum tolerated dose (MTD)
研究概览
简要总结
This is a 2-part, first-in-human, open-label study to determine the safety, tolerability and preliminary efficacy of KIVU-305, a CEACAM5-directed antibody-drug conjugate, in participants with locally advanced or metastatic solid 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
- •Male or female ≥18 years of age
- •Pathologically or histologically documented diagnosis of advanced / metastatic solid tumor malignancy that is resistant to standard therapy or for which no standard therapy is available
- •Adequate bone marrow, kidney, and liver function
- •Measurable disease using RECIST v1.1
- •ECOG 0 or 1
- •Life expectancy ≥ 3 months
排除标准
- •Prior treatment with any ADC with a topoisomerase 1 inhibitor payload
- •Prior treatment with any CEACAM5 targeted therapy
- •Uncontrolled cardiovascular disease
- •Uncontrolled active Hepatitis B, Hepatitis C, or HIV infection
- •History of interstitial lung disease
- •Major surgery, radiation therapy, or systemic anti-cancer within 3 weeks of study treatment start
研究组 & 干预措施
Dose Expansion
Experimental
Participants will be treated with the Recommended Dose for Expansion from Dose Finding.
干预措施: KIVU-305 (Drug)
Dose Finding
Experimental
Participants will be treated with KIVU-305 in multiple ascending cohorts
干预措施: KIVU-305 (Drug)
结局指标
主要结局
To determine Maximum tolerated dose (MTD)
时间窗: up to 18 months
Number of participants with treatment emergent adverse events as assessed by CTCAE Version 6.0.
次要结局
未报告次要终点
研究者
研究点 (3)
Loading locations...
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