Actively Recruiting
9MW2821 in Combination With Toripalimab vs Standard Chemotherapy in Locally Advanced or Metastatic Urothelial Cancer
Led by Mabwell (Shanghai) Bioscience Co., Ltd. · Updated on 2024-09-19
460
Participants Needed
1
Research Sites
223 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a randomized, controlled, open-label, multicenter phase 3 clinical study to evaluate the efficacy, safety and immunogenicity of 9MW2821 combined with Toripalimab versus standard chemotherapy in first-line locally advanced or metastatic urothelial cancer.
CONDITIONS
Official Title
9MW2821 in Combination With Toripalimab vs Standard Chemotherapy in Locally Advanced or Metastatic Urothelial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent approved by IEC
- Male or female aged 18 to 80 years
- ECOG performance status of 0 or 1
- Histologically confirmed locally advanced or metastatic urothelial cancer
- No prior systemic treatment for locally advanced or metastatic urothelial cancer
- At least one measurable lesion by RECIST V1.1
- Adequate tumor tissue available for testing
- Suitable for cisplatin or carboplatin-based chemotherapy as assessed by investigator
- Life expectancy more than 12 weeks
- Adequate organ function
- Use of proper contraception methods
- Willing to follow study procedures
You will not qualify if you...
- History of another malignancy within the past 3 years
- Autoimmune disease requiring systemic treatment within the past 2 years
- Significant cardiac, cerebrovascular diseases, or thrombosis within 6 months
- Major surgery within 28 days, live vaccines within 28 days, radiotherapy or intravesical therapy within 21 days, or use of certain medicines within 14 days
- Presence of large pleural fluid or ascites, uncontrolled bone pain or spinal compression within 14 days; active infection requiring systemic treatment within 7 days
- Prior treatment with PD-1, PD-L1, PD-L2, CTLA-4 inhibitors or ADCs targeting Nectin-4 or conjugated with MMAE
- History of organ transplantation or allogeneic stem cell transplantation
- Grade 2 or higher toxicity from previous treatments (except alopecia and pigmentation)
- Risk of severe dry eye, active keratitis, corneal ulcer, or peripheral neuropathy Grade 2 or above
- Serious chronic or uncontrolled disease
- Uncontrolled central nervous system metastases or carcinomatous meningitis
- Active HBV, HCV, or HIV infection
- Known allergy to study drug ingredients
- History of drug abuse or mental illness
- Other conditions unsuitable for study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
D
Dingwei Ye, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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