9MW2821 in Combination With Toripalimab vs Standard Chemotherapy in Locally Advanced or Metastatic Urothelial Cancer

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMabwell (Shanghai) Bioscience Co., Ltd.

About this trial

This is a randomized, controlled, open-label, multicenter phase 3 clinical study to evaluate the efficacy, safety and immunogenicity of 9MW2821 combined with Toripalimab versus standard chemotherapy in first-line locally advanced or metastatic urothelial cancer.

Eligibility criteria

Qualifiers

Sign the informed consent form approved by IEC.

Male or female subjects aged 18 to 80 years.

ECOG status: 0 or 1.

Histologically confirmed local advanced or metastatic urothelial cancer

Disqualifiers

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 6 months.

Major surgery treated within 28 days; Any live vaccines got within 28 days; Radiotherapy or Intravesical therapy treated within 21 days; Traditional Chinese medicine or any potent CYP3A4 inducers/inhibitors taken within 14 days.

Trial design

Treatments tested in this trial

  • 9MW2821
  • Toripalimab
  • Gemcitabine
  • Cisplatin/Carboplatin

Treatment groups

460 Participants
are divided into 2 treatment groups