Overview
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.