RecruitingPhase 2NCT07314723

9MW2821 Combined With Toripalimab in Perioperative Patients With 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

Sponsor

Mabwell (Shanghai) Bioscience Co., Ltd.

Enrollment

90 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

Urothelial Carcinoma

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

Min Age: 18 Years

Inclusion Criteria10

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 Criteria16

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.