Recruiting
Phase 2
9MW2821 Combined With Toripalimab in Perioperative Patients With Urothelial Cancer
Condition(s) studied
Urothelial Carcinoma
Investigational drug(s) / intervention(s)
9MW2821: 9MW2821, 1.25mg/kg, intravenous (IV) infusion
Toripalimab Injection: Toripalimab, 240mg, intravenous (IV) infusion
Study 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.
Primary outcome measure(s)
- pCR (Arm 1 and 2) — Up to 24 months
Pathological complete response
- cCR (Arm 3) — Up to 24 months
Clinical complete response
Trial sites (1)
| Facility | City | Region | Status |
| Sun Yat-sen University Cancer Center |
Guangzhou |
Guangdong |
Recruiting |
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