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Recruiting Phase 2

9MW2821 Combined With Toripalimab in Perioperative Patients With Urothelial Cancer

NCT07314723 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2025-08-01
Last updated
2026-01-02

Condition(s) studied

Urothelial Carcinoma

Investigational drug(s) / intervention(s)

9MW2821 →Toripalimab Injection →

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

Toripalimab Injection: Toripalimab, 240mg, intravenous (IV) infusion

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • pCR (Arm 1 and 2) — Up to 24 months
    Pathological complete response
  • cCR (Arm 3) — Up to 24 months
    Clinical complete response

Trial sites (1)

FacilityCityRegionStatus
Sun Yat-sen University Cancer Center Guangzhou Guangdong Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07314723 on ClinicalTrials.gov ↗ ← All trials in China