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

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.

Study Overview

• Status: Recruiting
• Conditions: Urothelial Carcinoma
• Intervention / Treatment: Drug: 9MW2821; Drug: Toripalimab Injection

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zhuowei Liu, Professor; Phone Number: 86-20-87343606; Email: liuzhw@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-sen University Cancer Center
      • Contact: Zhuowei Liu, Professor; Phone Number: 86-20-87343606; Email: liuzhw@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: MIBC	Drug: 9MW2821; 9MW2821, 1.25mg/kg, intravenous (IV) infusion; Drug: Toripalimab Injection; Toripalimab, 240mg, intravenous (IV) infusion
Experimental: Arm 2: High-risk UTUC	Drug: 9MW2821; 9MW2821, 1.25mg/kg, intravenous (IV) infusion; Drug: Toripalimab Injection; Toripalimab, 240mg, intravenous (IV) infusion
Experimental: Arm 3: MIBC	Drug: 9MW2821; 9MW2821, 1.25mg/kg, intravenous (IV) infusion; Drug: Toripalimab Injection; Toripalimab, 240mg, intravenous (IV) infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pCR (Arm 1 and 2)	Pathological complete response	Up to 24 months
cCR (Arm 3)	Clinical complete response	Up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	Overall Survival	Up to 24 months
cORR	Clinical objective response rate	Up to 24 months
Pathological downstaging rate (Arm 1 and 2)		Up to 24 months
DFS (Arm 1 and 2)	Disease-free survival	Up to 24 months
Duration of clinical complete response (Arm 3)		Up to 24 months
PFS (Arm 3)	Progression-free survival	Up to 24 months
AE/SAE	Adverse event, serious adverse event	Up to 24 months
Immunogenicity	Anti-Drug Antibody (ADA) of 9MW2821	Up to 24 months
Nectin-4 and PD-L1 expression		Up to 24 months

Collaborators and Investigators

• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: December 18, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Estimated): January 2, 2026

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Carcinoma, Transitional Cell; toripalimab
• Other Study ID Numbers: 9MW2821-CP202

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No