NCT05440045尚未招募2 期
A Phase 2, Multicenter, Open-Label Study to Evaluate the Preliminary Efficacy and Safety of 6MW3211 in Patients With Advanced Clear Cell Renal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- ORR
研究概览
简要总结
single arm, non-randomized, multicenter, open label, phase 2 clinical trial in patients with advanced clear cell renal cacer
详细描述
This study is a single arm, non-randomized, multicenter, open label, phase 2 clinical trial to evaluate preliminary efficacy and safety in patients with advanced clear cell renal cacer
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Voluntarily participate in the study and sign the informed consent.
- •Advanced clear cell renal cancer.
- •At least one measurable tumor target lesion.
- •Life expectancy≥3 months.
- •Suitable organ functions.
- •Patients who had failed at least one line therapy.
- •The samples of tumor tissue should be provided
排除标准
- •Patients who had received anti-tumor therapy/radiotherapy/immunotherapy within 4 weeks.
- •History of other malignant tumors within 5 years.
- •Patients with CNS metastasis.
- •History of active autoimmune diseases.
- •Patients with poor-controlled systemic diseases after treatment.
- •Patients with severe infection or requiring antibiotic treatment within 4 weeks before dosing.
- •Adverse reactions related to previous treatments failed to recover to CTCAE 5.0 ≤1
- •Patients who had experienced immune-related adverse events (irAE) with grade 3 or above.
- •Patients who were allergic to any composition of experimental drug.
- •Subjects with poor treatment compliance.
- •Pregnant or lactating woman.
- •Live vaccination within 28 days before first dosing.
- •History of drug abuse or addiction
- •Patients with active HBV or HCV, or HIV antibody positive,or Tp-Ab positive.
研究组 & 干预措施
6MW3211
Experimental
6MW3211 injection, 30mg/kg
干预措施: 6MW3211 (Drug)
结局指标
主要结局
ORR
时间窗: up to 24 months
Objective response rate
次要结局
未报告次要终点
研究者
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