Actively Recruiting
9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial Cancer
Led by Mabwell (Shanghai) Bioscience Co., Ltd. · Updated on 2024-09-19
100
Participants Needed
1
Research Sites
222 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase Ib/II, open-label, multicenter clinical study to evaluate the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of 9MW2821 combined with Toripalimab injection in subjects with local advanced or metastatic urothelial cancer.
CONDITIONS
Official Title
9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent approved by ethics committee
- Male or female aged 18 to 80 years
- ECOG performance status of 0 or 1
- Histologically or cytologically confirmed local advanced or metastatic urothelial cancer
- Received at least 1 line of advanced standard therapy or untreated
- Able to submit tumor tissue for testing
- Life expectancy of at least 12 weeks
- Measurable lesions according to RECIST version 1.1
- Adequate organ function
- Sexually active fertile subjects and partners agree to use contraception during the study and for 6 months after
- Willing to follow study procedures
You will not qualify if you...
- Anti-tumor treatment such as chemotherapy or radiotherapy within 21 days before first study drug dose
- Major surgery within 28 days before first study drug dose
- Prior treatment with PD-1/PD-L1/PD-L2 inhibitors for local advanced/metastatic urothelial cancer
- Previous treatment with ADCs conjugated with MMAE payload
- Clinical significant toxicity Grade 2 or higher from prior treatment (except alopecia and pigmentation)
- Peripheral neuropathy Grade 2 or higher
- Poorly controlled blood sugar
- Increased risk of corneal disease before first study drug dose
- History of significant cardiac or cerebrovascular disease within 6 months before first study drug dose
- Active infections such as uncontrolled HBV, HCV, HIV, or TB
- Other serious or uncontrolled diseases like serious interstitial pneumonia, asthma, or thromboembolic events
- Poorly controlled central nervous system metastases
- Past organ or allogeneic hematopoietic stem cell transplantation
- History of drug abuse or mental illness
- Known allergy to any study drug ingredients
- Use of P-glycoprotein or CYP3A4 inducers/inhibitors within 14 days before first study drug dose
- Autoimmune disease requiring systemic treatment within 2 years before first study drug dose
- Live vaccines within 4 weeks before or during the study
- Use of investigational drugs or medical devices within 28 days before first study drug dose
- History of another malignancy within 3 years before first study drug dose (except curable malignancies)
- Other conditions making participation unsuitable
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
Research Team
J
Jun Guo, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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