9MW2821 Combined With Toripalimab in Perioperative Patients With Urothelial Cancer

Summary

This is a single arm, open-label, multicenter phase II clinical study to evaluate the safety and efficacy of 9MW2821 combined with Toripalimab in perioperative patients with urothelial cancer.

Eligibility

Inclusion Criteria:

* Sign the informed consent form approved by IEC.
* Male or female subjects aged ≥18 years old.
* ECOG status: 0 or 1.
* Histologically confirmed urothelial cancer.
* Imaging confirmed non-metastatic urothelial cancer (M0). Arm 1: MIBC, T2-4aN0-1. Arm 2: High-risk UTUC, N0. Arm 3: MIBC, T2-4aN0.
* Adequate tumor tissues submitted for test.
* Life expectancy for more than 12 weeks.
* Adequate organ functions.
* Proper contraception methods.
* Willingness to follow the study procedures.

Exclusion Criteria:

* Prior systemic anti-tumor therapy for urothelial cancer.
* Previously treated with PD-1/PD-L1 inhibitors or antibody-drug conjugates (ADCs).
* 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 1 year.
* Major surgery treated within 28 days; Cystoscopy/ureteroscopy biopsy or intravesical instillation therapy within 7 days.
* Peripheral neuropathy Grade ≥ 2.
* Any situations adding the risk of severe dry eye, active keratitis or corneal ulcer, etc.
* Active HBV/HCV/HIV infection, etc.
* Any other serious chronic or uncontrolled disease.
* Any live vaccines got within 28 days.
* Organ transplantation or allogeneic hematopoietic stem cell transplantation in the past.
* Any potent CYP3A4 inducers/inhibitors taken within 14 days.
* 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.

Conditions2

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