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

Launched by MABWELL (SHANGHAI) BIOSCIENCE CO., LTD. · Oct 9, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option for patients with advanced urothelial cancer, which is a type of cancer that affects the bladder and urinary tract. The trial is testing a combination of two drugs: 9MW2821 and Toripalimab. Researchers want to find out if this combination is safe, how well it works, and how the body processes these medications.

To participate, individuals must be between 18 and 80 years old and have been diagnosed with advanced urothelial cancer. They should have already received at least one other treatment for their cancer or have never been treated before. Participants will need to provide tumor samples for testing and must be able to follow the study guidelines. If you join the trial, you will be monitored closely for any side effects and how well the treatment is working. It’s important to know that there are certain conditions and previous treatments that may exclude someone from participating, so discussing eligibility with a healthcare provider is essential.

Gender

ALL

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.