9MW2821 Combined With Toripalimab in Perioperative Patients With Urothelial Cancer

Mabwell Bioscience

Status and phase: Enrolling; Phase 2

Conditions: Urothelial Carcinoma

Treatments: Drug: 9MW2821; Drug: Toripalimab Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07314723

9MW2821-CP202

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Arm 1: MIBC

Experimental group

Treatment:

Drug: Toripalimab Injection

Drug: 9MW2821

Arm 2: High-risk UTUC

Experimental group

Treatment:

Drug: Toripalimab Injection

Drug: 9MW2821

Arm 3: MIBC

Experimental group

Treatment:

Drug: Toripalimab Injection

Drug: 9MW2821