Urothelial Carcinoma
Conditions
Brief 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.
Interventions
DRUG9MW2821
9MW2821, 1.25mg/kg, intravenous (IV) infusion
DRUGToripalimab Injection
Toripalimab, 240mg, intravenous (IV) infusion
Sponsors
Mabwell (Shanghai) Bioscience Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pCR (Arm 1 and 2) | Up to 24 months | Pathological complete response |
| cCR (Arm 3) | Up to 24 months | Clinical complete response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DFS (Arm 1 and 2) | Up to 24 months | Disease-free survival |
| Duration of clinical complete response (Arm 3) | Up to 24 months | — |
| PFS (Arm 3) | Up to 24 months | Progression-free survival |
| cORR | Up to 24 months | Clinical objective response rate |
| AE/SAE | Up to 24 months | Adverse event, serious adverse event |
| Immunogenicity | Up to 24 months | Anti-Drug Antibody (ADA) of 9MW2821 |
| Nectin-4 and PD-L1 expression | Up to 24 months | — |
| OS | Up to 24 months | Overall Survival |
| Pathological downstaging rate (Arm 1 and 2) | Up to 24 months | — |
Countries
China
Contacts
Primary ContactZhuowei Liu, Professor
Outcome results
None listed