The purpose of this study was to compare the antitumor activity of 9MW2821 and chemotherapy in participants with locally advanced or metastatic urothelial cancer previously treated with PD-(L)1 inhibitor and platinum-containing chemotherapy.
Competent to comprehend, sign, and date an independent ethics committee/institutional review board/research ethics board (IEC/IRB/REB) approved informed consent form.
Male or female subjects aged 18 to 75 years (including 18 and 75 years).
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Histologically confirmed locally advanced or metastatic urothelial cancer, not amenable to resection with curative intent.
Chemotherapy or radiotherapy within 21 days prior to the first dose of study drug, traditional Chinese medicine with anticancer indication within 14 days prior to the first dose of study drug, use of any investigational drug or device within 28 days prior to the first dose of study drug, received treatment of nectin-4 targeted ADC, received treatment of ADC with MMAE payload, received prior chemotherapy with all available study therapies in the control arm, any strong CYP3A4 inducers/inhibitors within 14 days prior to the first dose of study drug.
Preexisting treatment related toxicity Grade ≥ 2 (except alopecia and grade 2 endocrine system toxicity with stable replacement therapy).
Major surgery within 28 days prior to first dose of study drug.
Hemoglobin A1C (HbA1c) ≥ 8%.