9MW2821 in Combination With Toripalimab vs Standard Chemotherapy in Locally Advanced or Metastatic Urothelial Cancer

Launched by MABWELL (SHANGHAI) BIOSCIENCE CO., LTD. · Sep 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients with locally advanced or metastatic urothelial cancer, which is a type of bladder cancer. Researchers want to see how well a combination of two drugs, 9MW2821 and Toripalimab, works compared to standard chemotherapy that is usually given first for this condition. The trial is currently recruiting participants who are between 18 and 80 years old, have not received previous treatment for their cancer, and have a measurable tumor.

If you participate in this trial, you will be monitored closely for the effectiveness and safety of the treatment, and you may receive either the new drug combination or standard chemotherapy. To be eligible, you need to be in relatively good health, with certain organ functions working well, and have a life expectancy of at least 12 weeks. It's important to note that there are specific health conditions that might exclude you from joining, such as recent serious illnesses or treatments. Overall, this trial aims to find better treatment options for urothelial cancer and improve outcomes for patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Sign the informed consent form approved by IEC.
• • Male or female subjects aged 18 to 80 years.
• • ECOG status: 0 or 1.
• • Histologically confirmed local advanced or metastatic urothelial cancer
• • Previously untreated with local advanced or metastatic urothelial cancer
• • At least one measurable lesion, according to RECIST V1.1.
• • Adequate tumor tissues submitted for test
• • Suitable for cisplatin/carboplatin-based chemotherapy assessed by investigator
• • Life expectancy for more than 12 weeks.
• • Adequate organ functions.
• • Proper contraception methods.
• • Willingness to follow the study procedures.
• Exclusion Criteria:
• • History of another malignancy within 3 years.
• • History of autoimmune disease requiring systemic treatment within 2 years.
• • History of clinically significant cardiac/cerebrovascular diseases or thrombosis within 6 months.
• • Major surgery treated within 28 days; Any live vaccines got within 28 days; Radiotherapy or Intravesical therapy treated within 21 days; Traditional Chinese medicine or any potent CYP3A4 inducers/inhibitors taken within 14 days.
• • Lots of pleural fluid and ascites, uncontrolled bone pain or spinal compression existed within 14 days; Systemic treatment with active infection within 7 days.
• • Previously treated with PD-1, PD-L1, PD-L2, CTLA-4 inhibitors; Previously treated with ADCs which target Nectin-4 or are conjugated with payload MMAE; Organ transplantation or allogeneic hematopoietic stem cell transplantation in the past.
• • Clinical significantly toxicity Grade ≥ 2 (except alopecia and pigmentation) related to previous treatment.
• • Any situations adding the risk of severe dry eye, active keratitis or corneal ulcer, etc.
• • Peripheral neuropathy Grade ≥ 2.
• • Any other serious chronic or uncontrolled disease.
• • Uncontrolled central nervous system metastases or carcinomatous meningitis.
• • Active HBV/HCV/HIV infection, etc.
• • Known allergic sensitivity to any of the ingredients of the study drug.
• • History of drug abuse or mental illness.
• • Other conditions unsuitable into the study.