9MW2821 + Toripalimab vs 9MW2821 for 1st Line Locally Advanced or Metastatic Urothelial Carcinoma

Launched by MABWELL (SHANGHAI) BIOSCIENCE CO., LTD. · Feb 6, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating the effectiveness of a combination treatment called 9MW2821 plus toripalimab compared to the single treatment of 9MW2821 for patients with advanced or spread urothelial carcinoma, which includes bladder cancer and cancer of the renal pelvis and ureter. The study is specifically for patients who have not yet received any systemic treatments for their cancer.

To participate, individuals must be between 18 and 80 years old and have a confirmed diagnosis of inoperable locally advanced or metastatic urothelial carcinoma. They should also have at least one measurable tumor and be in reasonably good health. Participants can expect regular visits for treatment and monitoring, and they will need to agree to use contraception during the study. This trial is currently recruiting participants, so if you or someone you know meets the eligibility criteria, it might be a good opportunity to consider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Voluntary participation
• • Age 18-80
• • ECOG 0-1
• • Histologically confirmed inoperable locally advanced or metastatic urothelial carcinoma (including bladder, renal pelvis and ureter). Mixed histology with squamous or adenomatous differentiation is allowed if urothelial carcinoma differentiation is \>50%.
• • Has not received any systemic treatment for locally advanced or metastatic urothelial carcinoma
• • At least 1 measurable target lesion that satisfies RECIST v1.1 definition. If the patient has received radiotherapy, the target lesion needs to be outside the radiation field or has demonstrated clear progression after radiotherapy.
• • Life expectancy over 12 weeks
• • Appropriate hematological and organ functions
• • Agree to contraceptive measures until 180 days after the last dose of study drug administration
• • Able to understand and follow study visits, treatment, laboratory assessment and other procedures
• Exclusion Criteria:
• • Other concurrent malignancy within 3 years prior to randomization
• • Active autoimmune disease requiring systemic treatment within 2 years prior to randomization. Having received high dose corticosteroid (\>10mg/day prednisolone equivalent) or other immunosuppressive agents.
• • Severe cardiovascular or cerebral vascular thrombo-embolic events within 6 months prior to randomization
• • Major surgery within 28 days prior to randomization, except for minor procedures that the PI considers not to impact study participation. Live vaccine within 28 days prior to randomization or planning to take live vaccine during the study. Radiotherapy or bladder infusion therapy within 21 days prior to randomization. Use of strong CYP3A4 inhibitors within 14 days prior to randomization.
• • Lung effusion or ascites that require treatment within 14 days prior to randomization. Cancer-related severe uncontrolled bone pain or spinal cord compression within 14 days prior to randomization. Active infection that requires systemic antibiotic treatment within 7 days prior to randomization.
• • Have received prior treatment with anti-PD-1, anti-PD-L1/PD-L2 or anti-CTLA-4 therapies. Have received prior treatment with Nectin-4 targeted therapy or ADC with MMAE as payload. Have received allogeneic hematological stem cell transplantation or solid organ transplant.
• • Toxicities from previous cancer treatment (radiotherapy, chemotherapy or surgery) that have not recovered to grade 0-1 according to CTCAE v5.0, except for alopecia and skin hyperpigmentation.
• • Severe dry eyes, active keratitis, corneal ulceration or other risk factors for corneal diseases where the PI judges to be not suited for this study
• • Preexisting grade ≥ 2 neuropathy prior to randomization
• • Other uncontrolled serious illness
• • Brain metastasis or meningeal carcinomatosis
• • HBsAg positive, and HBV-DNA copy number positive ; HCV-Ab positive and HCV-RNA positive; HIV-Ab positive
• • Known allergy to the study drug or components of the study drug
• • Drug abuse or psychiatric disorder that would impact study compliance
• • Other circumstances that the PI judges to be not suitable for the study