Actively Recruiting
A Phase Ib/II, Open-label, Single Arm, Multicenter Study to Evaluate Safety and Efficacy of 9MW2821 Combined With Toripalimab Injection in Local Advanced or Metastatic Urothelial Cancer
Led by Mabwell (Shanghai) Bioscience Co., Ltd. · Updated on 2024-09-19
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, effectiveness, pharmacokinetics, and immune response of a combination treatment using 9MW2821 and Toripalimab injections in adults with locally advanced or metastatic urothelial cancer. This phase Ib/II open-label study is conducted at multiple centers to better understand this treatment approach for this advanced cancer type. Participants receive 9MW2821 at doses of 1.0, 1.25, or 1.5 mg/kg by intravenous infusion every cycle, combined with 240 mg of Toripalimab given intravenously every cycle. Treatment continues until the disease progresses or side effects become intolerable. This single-arm trial does not include a comparison group and monitors patients closely during the treatment period. During the study, participants undergo regular assessments including safety monitoring for adverse events up to 24 months. Researchers also measure tumor response, progression-free survival, overall survival, and pharmacokinetics over 12 to 24 months. Participants must provide tumor tissue samples and complete study procedures, with ongoing monitoring of immunogenicity and disease control throughout the trial duration.
CONDITIONS
Brief 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.
- Confirmed local advanced or metastatic urothelial cancer.
- Received at least one line of advanced standard therapy or untreated.
- Must provide tumor tissue for testing.
- Life expectancy of at least 12 weeks.
- Measurable lesions per RECIST 1.1 criteria.
- Adequate organ function.
- Sexually active fertile participants and partners agree to use contraception during study and for 6 months after.
- Willing to follow study procedures.
You will not qualify if you...
- Anti-tumor treatment like chemotherapy or radiotherapy within 21 days before first study drug dose.
- Major surgery within 28 days before first study drug dose.
- Previous PD-1/PD-L1/PD-L2 inhibitor treatment for local advanced or metastatic urothelial cancer.
- Prior treatment with ADCs containing MMAE payload.
- 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.
- Significant cardiac or cerebrovascular disease within 6 months before first dose.
- Active uncontrolled infections such as HBV, HCV, HIV, or TB.
- Other serious or uncontrolled diseases (e.g., interstitial pneumonia, severe asthma).
- Poorly controlled brain metastases.
- Past organ or stem cell transplantation.
- History of drug abuse or mental illness.
- Known allergy to study drug ingredients.
- Use of P-glycoprotein or CYP3A4 inducers/inhibitors within 14 days before first dose.
- Autoimmune disease requiring systemic treatment within 2 years before first dose.
- Live vaccines within 4 weeks before or during study.
- Use of investigational drugs or devices within 28 days before first dose.
- History of another malignancy within 3 years, except curable cancers.
- Other conditions making participation unsuitable.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression or intolerable toxicity
Participants receive 9MW2821 and Toripalimab through intravenous infusion every cycle until disease progression or intolerable toxicity.
Repeated visits every treatment cycle for intravenous infusion
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
Research Team
J
Jun Guo, Professor
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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