Combining 9MW2821 with toripalimab around surgery for urothelial cancer

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 trial tests whether giving 9MW2821 together with toripalimab before and after surgery helps adults with non-metastatic urothelial cancer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. (industry)
• Drugs / interventions: Toripalimab
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07314723 on ClinicalTrials.gov

What this trial studies

This is a single-arm, open-label, multicenter Phase II trial administering 9MW2821 plus toripalimab to perioperative patients with non-metastatic urothelial carcinoma. Enrollees are placed into arms that include muscle-invasive bladder cancer and high-risk upper tract disease and receive the combination therapy around the time of definitive surgery. Key eligibility includes ECOG 0–1, adequate organ function, available tumor tissue, and no prior systemic therapy for urothelial cancer. The study, led at Sun Yat-sen University Cancer Center, monitors safety and anti-tumor activity such as pathologic response and recurrence outcomes.

Who should consider this trial

Good fit: Adults with non-metastatic (M0) urothelial carcinoma who are fit for surgery (ECOG 0–1), have not had prior systemic therapy, and can provide tumor tissue are ideal candidates.

Not a fit: Patients with metastatic disease, prior PD‑1/PD‑L1 or ADC therapy, active autoimmune disease requiring systemic treatment, recent major cardiac or thrombotic events, or inadequate organ function are unlikely to benefit.

Why it matters

Potential benefit: If successful, the combination could increase tumor response around surgery and reduce the risk of recurrence.

How similar studies have performed: Other perioperative approaches combining PD‑1 inhibitors with antibody-based agents have shown promising pathologic responses in urothelial cancer, but the specific 9MW2821 plus toripalimab combination is novel.

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.

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: Zhuowei Liu, Professor

Conditions: Urothelial Carcinoma