9MW2821 Combined With Toripalimab in Perioperative Patients With Urothelial Cancer

NCT07314723 | Recruiting Phase 2 DMC

• 1 other identifier: 9MW2821-CP202
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Urothelial Carcinoma

Outcome Measures

Primary Outcomes (2)

• pCR (Arm 1 and 2)

  Pathological complete response

  Up to 24 months

• cCR (Arm 3)

  Clinical complete response

  Up to 24 months

Secondary Outcomes (9)

• cORR

  Up to 24 months

• Pathological downstaging rate (Arm 1 and 2)

  Up to 24 months

• DFS (Arm 1 and 2)

  Up to 24 months

• Duration of clinical complete response (Arm 3)

  Up to 24 months

• PFS (Arm 3)

  Up to 24 months

Study Arms (3)

Arm 1: MIBC

EXPERIMENTAL

Drug: 9MW2821; Drug: Toripalimab Injection

Arm 2: High-risk UTUC

EXPERIMENTAL

Drug: 9MW2821; Drug: Toripalimab Injection

Arm 3: MIBC

EXPERIMENTAL

Drug: 9MW2821; Drug: Toripalimab Injection

Interventions

9MW2821 DRUG

9MW2821, 1.25mg/kg, intravenous (IV) infusion

Arm 1: MIBC; Arm 2: High-risk UTUC; Arm 3: MIBC

Toripalimab Injection DRUG

Toripalimab, 240mg, intravenous (IV) infusion

Arm 1: MIBC; Arm 2: High-risk UTUC; Arm 3: MIBC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

toripalimab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Zhuowei Liu, Professor

CONTACT

86-20-87343606; liuzhw@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 2, 2026
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

CN (1)