9MW2821 Combined With Toripalimab in Perioperative Patients With Urothelial Cancer
NCT ID: NCT07314723
Last Updated: 2026-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
90 participants
INTERVENTIONAL
2025-08-01
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1: MIBC
9MW2821
9MW2821, 1.25mg/kg, intravenous (IV) infusion
Toripalimab Injection
Toripalimab, 240mg, intravenous (IV) infusion
Arm 2: High-risk UTUC
9MW2821
9MW2821, 1.25mg/kg, intravenous (IV) infusion
Toripalimab Injection
Toripalimab, 240mg, intravenous (IV) infusion
Arm 3: MIBC
9MW2821
9MW2821, 1.25mg/kg, intravenous (IV) infusion
Toripalimab Injection
Toripalimab, 240mg, intravenous (IV) infusion
Interventions
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9MW2821
9MW2821, 1.25mg/kg, intravenous (IV) infusion
Toripalimab Injection
Toripalimab, 240mg, intravenous (IV) infusion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Mabwell (Shanghai) Bioscience Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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9MW2821-CP202
Identifier Type: -
Identifier Source: org_study_id
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