Tests 9MW2821 with toripalimab in advanced urothelial cancer
Tests 9MW2821 with toripalimab in adults with advanced urothelial cancer.
Plain-language title generated from the registry record
Registry title: 9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial Cancer
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06079112, who can take part
Where in China
- Beijing Cancer HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Mabwell (Shanghai) Bioscience Co., Ltd.
- Trial code
- NCT06079112
- Record updated
- 19 September 2024
- Original description
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.Read full original descriptionShow less
A Phase Ib/II, Open-label, Single Arm, Multicenter Clinical Study to Evaluate the Safety and Efficacy of 9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial Cancer
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.
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; 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; Organ transplantation or allogeneic hematopoietic stem cell transplantation in the past; Any P-glycoprotein (P-gp) inducers/inhibitors or potent CYP3A4 inducers/inhibitors within 14 days prior to the first dose of study drug; 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; 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; History of drug abuse or mental illness; Known allergic sensitivity to any of the ingredients of the study drug; History of autoimmune disease requiring systemic treatment within 2 years before the first dose; 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; Peripheral neuropathy Grade ≥ 2; Poorly controlled blood sugar; Poorly controlled central nervous system metastases.