9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial Cancer

• Status: Not yet recruiting
• Trial end date: 2027-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

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.