Actively Recruiting
9MW2821 Combined With Toripalimab in Perioperative Patients With Urothelial Cancer
Led by Mabwell (Shanghai) Bioscience Co., Ltd. · Updated on 2026-01-02
90
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
9MW2821 Combined With Toripalimab in Perioperative Patients With Urothelial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent approved by IEC
- Male or female aged 18 years or older
- ECOG performance status of 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 tissue available for testing
- Life expectancy greater than 12 weeks
- Adequate organ function
- Use of proper contraception methods
- Willingness to follow study procedures
You will not qualify if you...
- Prior systemic anti-tumor therapy for urothelial cancer
- Previous treatment with PD-1/PD-L1 inhibitors or antibody-drug conjugates
- History of another cancer within the past 3 years
- Autoimmune disease requiring systemic treatment within 2 years
- Significant cardiac, cerebrovascular diseases, or thrombosis within 1 year
- Major surgery within 28 days; cystoscopy/ureteroscopy biopsy or intravesical therapy within 7 days
- Peripheral neuropathy grade 2 or higher
- Conditions increasing risk of severe dry eye, active keratitis, or corneal ulcer
- Active hepatitis B, hepatitis C, or HIV infection
- Serious chronic or uncontrolled diseases
- Live vaccines received within 28 days
- Organ or stem cell transplantation in the past
- Use of strong CYP3A4 inducers or inhibitors within 14 days
- Known allergy to study drug ingredients
- History of drug abuse or mental illness
- Other conditions making participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
Z
Zhuowei Liu, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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