Status:
RECRUITING
9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial Cancer
Lead Sponsor:
Mabwell (Shanghai) Bioscience Co., Ltd.
Conditions:
Advanced Urothelial Carcinoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
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 subj...
Eligibility Criteria
Inclusion
- Sign and date the informed consent form e approved by independent ethics committe.
- Male or female subjects aged 18 to 80 years (including 18 and 80 years).
- ECOG status of 0 or 1.
- Histologically or cytologically confirmed local advanced or metastatic urothelial cancer
- Subjects have received at least 1 line advanced standard therapy or were not treated before
- Subjects must submit tumor tissues for test
- Life expectancy of ≥ 12 weeks.
- Subjects must have measurable lesions according to RECIST (version 1.1).
- Adequate organ functions
- Sexually active fertile subjects, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy.
- Subjects are willing to follow study procedures.
Exclusion
- Anti-tumor treatment such as chemotherapy and radiotherapy within 21 days prior to the first dose of study drug.
- Major surgery within 28 days prior to first dose of study drug.
- PD-1/PD-L1/PD-L2 inhibitors used in the previous treatment for La/m UC.
- Previous treatment with ADCs conjugated with MMAE payload.
- Clinical significantly toxicity Grade ≥ 2 (except alopecia and pigmentation) related to previous treatment.
- Peripheral neuropathy Grade ≥ 2.
- Poorly controlled blood sugar.
- Increased risks of corneal disease assessed by the investigator prior to the first dose of study drug.
- Documented history of clinically significant cardiac or cerebrovascular diseases within 6 months prior to the first dose of study drug.
- Active infections, such as uncontrolled HBV/HCV/HIV/TB infection, etc.
- Other serious or uncontrolled diseases, such as serious interstitial pneumonia/asthma, serious thromboembolic events, etc.
- Poorly controlled central nervous system metastases.
- Organ transplantation or allogeneic hematopoietic stem cell transplantation in the past.
- History of drug abuse or mental illness.
- Known allergic sensitivity to any of the ingredients of the study drug.
- Any P-glycoprotein (P-gp) inducers/inhibitors or potent CYP3A4 inducers/inhibitors within 14 days prior to the first dose of study drug.
- History of autoimmune disease requiring systemic treatment within 2 years before the first dose.
- Any live vaccines within 4 weeks before first dose of study drug or during the study.
- Use of any investigational drug or medical instruments within 28 days prior to the first dose of study drug.
- History of another malignancy within 3 years before the first dose of study drug. Subjects with curable malignancies are allowed.
- Other conditions unsuitable into the study.
Key Trial Info
Start Date :
September 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06079112
Start Date
September 27 2023
End Date
December 31 2027
Last Update
September 19 2024
Active Locations (1)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142