NCT06079112尚未招募1 期
A Phase Ib/II, Open-label, Single Arm, Multicenter Clinical Study to Evaluate the Safety and Efficacy of 9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial Cancer
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
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- incidence of AE/SAE
研究概览
简要总结
This is a phase Ib/II, open-label, multicenter clinical study to evaluate the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of 9MW2821 combined with Toripalimab injection in subjects with local advanced or metastatic urothelial cancer.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign and date the informed consent form e approved by independent ethics committe.
- •Male or female subjects aged 18 to 80 years (including 18 and 80 years).
- •ECOG status of 0 or
- •Histologically or cytologically confirmed local advanced or metastatic urothelial cancer
- •Subjects have received at least 1 line advanced standard therapy or were not treated before
- •Subjects must submit tumor tissues for test
- •Life expectancy of ≥ 12 weeks.
- •Subjects must have measurable lesions according to RECIST (version 1.1).
- •Adequate organ functions
- •Sexually active fertile subjects, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy.
- •Subjects are willing to follow study procedures.
排除标准
- •Anti-tumor treatment such as chemotherapy and radiotherapy within 21 days prior to the first dose of study drug.
- •Major surgery within 28 days prior to first dose of study drug.
- •PD-1/PD-L1/PD-L2 inhibitors used in the previous treatment for La/m UC.
- •Previous treatment with ADCs conjugated with MMAE payload.
- •Clinical significantly toxicity Grade ≥ 2 (except alopecia and pigmentation) related to previous treatment.
- •Peripheral neuropathy Grade ≥
- •Poorly controlled blood sugar.
- •Increased risks of corneal disease assessed by the investigator prior to the first dose of study drug.
- •Documented history of clinically significant cardiac or cerebrovascular diseases within 6 months prior to the first dose of study drug.
- •Active infections, such as uncontrolled HBV/HCV/HIV/TB infection, etc.
- •Other serious or uncontrolled diseases, such as serious interstitial pneumonia/asthma, serious thromboembolic events, etc.
- •Poorly controlled central nervous system metastases.
- •Organ transplantation or allogeneic hematopoietic stem cell transplantation in the past.
- •History of drug abuse or mental illness.
- •Known allergic sensitivity to any of the ingredients of the study drug.
- •Any P-glycoprotein (P-gp) inducers/inhibitors or potent CYP3A4 inducers/inhibitors within 14 days prior to the first dose of study drug.
- •History of autoimmune disease requiring systemic treatment within 2 years before the first dose.
- •Any live vaccines within 4 weeks before first dose of study drug or during the study.
- •Use of any investigational drug or medical instruments within 28 days prior to the first dose of study drug.
- •History of another malignancy within 3 years before the first dose of study drug. Subjects with curable malignancies are allowed.
- •Other conditions unsuitable into the study.
研究组 & 干预措施
9MW2821+Toripalimab
Experimental
干预措施: 9MW2821 (Drug)
9MW2821+Toripalimab
Experimental
干预措施: Toripalimab (Drug)
结局指标
主要结局
incidence of AE/SAE
时间窗: Up to 24 months
adverse event(AE) 、serious adverse event(SAE)
次要结局
- Objective Response Rate, ORR(Up to 24 months)
- Duration of Response, DOR(Up to 24 months)
- Disease Control Rate, DCR(Up to 24 months)
- Progression-Free Survival, PFS(Up to 24 months)
- Time To Response, TTR(Up to 24 months)
- Overall Survival, OS(Up to 24 months)
- Pharmacokinetics parameter(Up to 12 months)
- Immunogenicity parameter(Up to 12 months)
研究者
研究点 (1)
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