9MW2821 Combined With Toripalimab in Perioperative Patients With Urothelial Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMabwell (Shanghai) Bioscience Co., Ltd.

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • 9MW2821
  • Toripalimab Injection

Treatment groups

90 Participants
are divided into 3 treatment groups