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Trial Title:
9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial Cancer
NCT ID:
NCT06079112
Condition:
Advanced Urothelial Carcinoma
Conditions: Official terms:
Carcinoma, Transitional Cell
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
9MW2821
Description:
1.0/1.25/1.5 mg/kg, intravenous (IV) infusion every cycle until disease progression or
intolerable toxicity, etc.
Arm group label:
9MW2821+Toripalimab
Other name:
9MW2821 injection
Intervention type:
Drug
Intervention name:
Toripalimab
Description:
240mg intravenous (IV) infusion every cycle until disease progression or intolerable
toxicity, etc.
Arm group label:
9MW2821+Toripalimab
Other name:
Toripalimab injection
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 subjects with local advanced or metastatic urothelial cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Jun Guo, Professor
Phone:
010-88196358
Email:
guoj307@126.com
Start date:
September 27, 2023
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Mabwell (Shanghai) Bioscience Co., Ltd.
Agency class:
Industry
Source:
Mabwell (Shanghai) Bioscience Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06079112
