Clinical trial · Interventional
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
NCT07314723CI-TRIAL-00100003recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 9MW2821 | Drug | — | UNRESOLVED |
| Toripalimab Injection | Drug | Toripalimab | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm 1: MIBC
- interventionNames
- Drug: 9MW2821
- Drug: Toripalimab Injection
- type
- EXPERIMENTAL
- label
- Arm 2: High-risk UTUC
- interventionNames
- Drug: 9MW2821
- Drug: Toripalimab Injection
- type
- EXPERIMENTAL
- label
- Arm 3: MIBC
- interventionNames
- Drug: 9MW2821
- Drug: Toripalimab Injection
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.