NCT07314723招募中2 期
A Single Arm, Open-label, Multicenter, Phase II Clinical Study to Evaluate the Safety and Efficacy of 9MW2821 Combined With Toripalimab in Perioperative Patients With Urothelial Cancer
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- pCR (Arm 1 and 2)
研究概览
简要总结
This is a single arm, open-label, multicenter phase II clinical study to evaluate the safety and efficacy of 9MW2821 combined with Toripalimab in perioperative patients with urothelial cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign the informed consent form approved by IEC.
- •Male or female subjects aged ≥18 years old.
- •ECOG status: 0 or
- •Histologically confirmed urothelial cancer.
- •Imaging confirmed non-metastatic urothelial cancer (M0). Arm 1: MIBC, T2-4aN0-
- •Arm 2: High-risk UTUC, N
- •Arm 3: MIBC, T2-4aN
- •Adequate tumor tissues submitted for test.
- •Life expectancy for more than 12 weeks.
- •Adequate organ functions.
- •Proper contraception methods.
- •Willingness to follow the study procedures.
排除标准
- •Prior systemic anti-tumor therapy for urothelial cancer.
- •Previously treated with PD-1/PD-L1 inhibitors or antibody-drug conjugates (ADCs).
- •History of another malignancy within 3 years.
- •History of autoimmune disease requiring systemic treatment within 2 years.
- •History of clinically significant cardiac/cerebrovascular diseases or thrombosis within 1 year.
- •Major surgery treated within 28 days; Cystoscopy/ureteroscopy biopsy or intravesical instillation therapy within 7 days.
- •Peripheral neuropathy Grade ≥
- •Any situations adding the risk of severe dry eye, active keratitis or corneal ulcer, etc.
- •Active HBV/HCV/HIV infection, etc.
- •Any other serious chronic or uncontrolled disease.
- •Any live vaccines got within 28 days.
- •Organ transplantation or allogeneic hematopoietic stem cell transplantation in the past.
- •Any potent CYP3A4 inducers/inhibitors taken within 14 days.
- •Known allergic sensitivity to any of the ingredients of the study drug.
- •History of drug abuse or mental illness.
- •Other conditions unsuitable into the study.
研究组 & 干预措施
Arm 1: MIBC
Experimental
干预措施: 9MW2821 (Drug)
Arm 1: MIBC
Experimental
干预措施: Toripalimab Injection (Drug)
Arm 2: High-risk UTUC
Experimental
干预措施: 9MW2821 (Drug)
Arm 2: High-risk UTUC
Experimental
干预措施: Toripalimab Injection (Drug)
Arm 3: MIBC
Experimental
干预措施: 9MW2821 (Drug)
Arm 3: MIBC
Experimental
干预措施: Toripalimab Injection (Drug)
结局指标
主要结局
pCR (Arm 1 and 2)
时间窗: Up to 24 months
Pathological complete response
cCR (Arm 3)
时间窗: Up to 24 months
Clinical complete response
次要结局
- cORR(Up to 24 months)
- Pathological downstaging rate (Arm 1 and 2)(Up to 24 months)
- OS(Up to 24 months)
- DFS (Arm 1 and 2)(Up to 24 months)
- Duration of clinical complete response (Arm 3)(Up to 24 months)
- Immunogenicity(Up to 24 months)
- Nectin-4 and PD-L1 expression(Up to 24 months)
- PFS (Arm 3)(Up to 24 months)
- AE/SAE(Up to 24 months)
研究者
研究点 (1)
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