Tests 9MW2821 with toripalimab around surgery for urothelial cancer
Tests 9MW2821 with toripalimab in adults with urothelial cancer before and after surgery.
Plain-language title generated from the registry record
Registry title: 9MW2821 Combined With Toripalimab in Perioperative Patients With Urothelial Cancer
Key facts
- Where
- Guangzhou, ChinaSee the site
- Phase
- Phase 2
Where in China
- Sun Yat-sen University Cancer CenterGuangzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Mabwell (Shanghai) Bioscience Co., Ltd.
- Trial code
- NCT07314723
- Record updated
- 2 January 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Sign the informed consent form approved by IEC; Male or female subjects aged ≥18 years old; ECOG status: 0 or 1; Histologically confirmed urothelial cancer; Imaging confirmed non-metastatic urothelial cancer (M0). Arm 1: MIBC, T2-4aN0-1. Arm 2: High-risk UTUC, N0. Arm 3: MIBC, T2-4aN0; 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.
Exclusion: Prior systemic anti-tumor therapy for urothelial cancer; Previously treated with PD-1/PD-L1 inhibitors or antibody-drug conjugates (ADCs); Major surgery treated within 28 days; Cystoscopy/ureteroscopy biopsy or intravesical instillation therapy within 7 days; 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; 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; 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; 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; Peripheral neuropathy Grade ≥ 2.