NCT07314723 9MW2821 Combined With Toripalimab in Perioperative Patients With Urothelial Cancer
| NCT ID | NCT07314723 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Mabwell (Shanghai) Bioscience Co., Ltd. |
| Condition | Urothelial Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 90 participants in total. It began in 2025-08-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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 ≥ 2. * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07314723 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Urothelial Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07314723 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07314723 currently recruiting?
Yes, NCT07314723 is actively recruiting participants. Contact the research team at liuzhw@sysucc.org.cn for enrollment information.
Where is the NCT07314723 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07314723 clinical trial?
NCT07314723 is sponsored by Mabwell (Shanghai) Bioscience Co., Ltd.. The trial plans to enroll 90 participants.