9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial Cancer

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMabwell (Shanghai) Bioscience Co., Ltd.

About this trial

This is a phase Ib/II, open-label, multicenter clinical study to evaluate the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of 9MW2821 combined with Toripalimab injection in subjects with local advanced or metastatic urothelial cancer.

Eligibility criteria

Qualifiers

Sign and date the informed consent form e approved by independent ethics committe.

Male or female subjects aged 18 to 80 years (including 18 and 80 years).

ECOG status of 0 or 1.

Histologically or cytologically confirmed local advanced or metastatic urothelial cancer

Disqualifiers

Anti-tumor treatment such as chemotherapy and radiotherapy within 21 days prior to the first dose of study drug.

Major surgery within 28 days prior to first dose of study drug.

PD-1/PD-L1/PD-L2 inhibitors used in the previous treatment for La/m UC.

Previous treatment with ADCs conjugated with MMAE payload.

Trial design

Treatments tested in this trial

  • 9MW2821
  • Toripalimab

Treatment groups

100 Participants
are divided into 1 treatment group