NCT07636772尚未招募2 期
A Phase II Clinical Study to Evaluate the Safety，Tolerability，Pharmacokinetics and Anti-tumor Efficacy of AK146D1 Monotherapy or Combined With AK112 in Patients With Advanced Urothelial Carcinoma
Akeso1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2026年6月22日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 132
- 试验地点
- 1
研究概览
简要总结
This is a Phase II clinical study aimed at evaluating the safety, tolerability, antitumor efficacy, PK and immunogenicity of AK146D1 monotherapy or combined with AK112 in advanced Urothelial carcinoma.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be able to understand and voluntarily sign the written informed consent form.
- •ECOG PS 0 or
- •Expected lifespan ≥3 months.
- •Histologically or cytologically documented Urothelial carcinoma.
- •At least one measurable lesion according to RECIST v1.
- •Sufficient organ function.
排除标准
- •Having other active malignancies within 3 years.
- •Currently participating in another interventional clinical study.
- •Presence of active metastases to the central nervous system.
- •Prior chemotherapy agent targeting topoisomerase I .
- •Receipt of systemic anti-tumor therapy within 4 weeks prior to the first dose.
- •Patients with clinically significant cardiovascular or cerebrovascular diseases or risks.
- •Patients with active autoimmune diseases requiring systemic treatment within 2 years.
- •Receipt of systemic anti-infective therapy within 2 weeks prior to the first dose.
- •Previous history of severe hypersensitivity reactions.
- •Patients with a history of mental illness and incapacitated or limited capacity.
- •Any disease or condition that, in the opinion of the investigator, would compromise patient safety or interfere with study assessments.
研究者
研究点 (1)
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