Actively Recruiting
9MW2821 Combined With Toripalimab in Perioperative Patients With Urothelial Cancer Phase II Study
Led by Mabwell (Shanghai) Bioscience Co., Ltd. · Updated on 2026-01-02
90
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of combining the drugs 9MW2821 and Toripalimab in patients with urothelial cancer who are undergoing surgery. This phase II clinical trial is open-label and involves multiple centers. The study focuses on patients with confirmed non-metastatic urothelial cancer, including muscle-invasive bladder cancer (MIBC) and high-risk upper tract urothelial carcinoma (UTUC). Participants receive intravenous infusions of 9MW2821 at a dose of 1.25 mg/kg and Toripalimab at 240 mg. The study includes three groups based on cancer type and risk: Arm 1 with MIBC, Arm 2 with high-risk UTUC, and Arm 3 with MIBC. The study is not randomized, and all participants receive the experimental treatment combination. During the study, participants will be monitored for up to 24 months to assess outcomes such as pathological complete response (pCR), clinical complete response (cCR), overall response rate, disease-free survival, progression-free survival, overall survival, and safety events. Researchers will also evaluate immunogenicity and expression of biomarkers Nectin-4 and PD-L1. Regular assessments include tumor tissue testing and organ function monitoring to ensure participant safety and treatment adherence.
CONDITIONS
Brief Title
9MW2821 Combined With Toripalimab in Perioperative Patients With Urothelial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form approved by IEC
- Male or female aged 18 years or older
- ECOG performance status of 0 or 1
- Histologically confirmed urothelial cancer
- Imaging confirmed non-metastatic urothelial cancer (M0): Arm 1 with MIBC T2-4aN0-1, Arm 2 with high-risk UTUC N0, Arm 3 with MIBC T2-4aN0
- Adequate tumor tissue available for testing
- Life expectancy greater than 12 weeks
- Adequate organ function
- Use of proper contraception methods
- Willingness to follow study procedures
You will not qualify if you...
- Prior systemic anti-tumor therapy for urothelial cancer
- Previous treatment with PD-1/PD-L1 inhibitors or antibody-drug conjugates
- History of another malignancy within 3 years
- History of autoimmune disease requiring systemic treatment within 2 years
- Significant cardiac, cerebrovascular diseases, or thrombosis within 1 year
- Major surgery within 28 days; cystoscopy, ureteroscopy biopsy, or intravesical therapy within 7 days
- Peripheral neuropathy Grade 2 or higher
- Conditions increasing risk of severe dry eye, active keratitis, or corneal ulcer
- Active infection with HBV, HCV, or HIV
- Serious chronic or uncontrolled diseases
- Live vaccines within 28 days
- Prior organ transplantation or allogeneic hematopoietic stem cell transplantation
- Use of potent CYP3A4 inducers or inhibitors within 14 days
- Known allergy to study drug ingredients
- History of drug abuse or mental illness
- Other conditions unsuitable for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 24 months
Participants receive intravenous infusions of 9MW2821 and Toripalimab as part of their perioperative treatment for urothelial cancer.
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
Z
Zhuowei Liu, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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