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%.
Parallel
9MW2821
Drug1.25mg/kg of 9MW2821 by intravenous infusion on days 1, 8 and 15 of every 28-day cycle
Chemotherapy
Drug75mg/m\^2 docetaxel by intravenous infusion or 175 mg/m\^2 paclitaxel by intravenous infusion on day 1 of every 21-day cycle.
Progression Free Survival per Blinded Independent Central Review
Time from the date of first randomization to the earliest date of documented disease progression per radiological evidence or death from any cause
Overall Survival
Time from the date of randomization until the date of death from any cause
Objective Response Rate per Blinded Independent Central Review and investigator
The percentage of subjects who experience a best response of either CR or PR
Duration of Response per Blinded Independent Central Review and investigator
Time from the date of the first complete response (CR) or partial response (PR) to the earliest date of disease progression or death from any cause
Time to response per Blinded Independent Central Review and investigator
Time from the date of randomization to the date of confirmed CR or PR
Disease Control Rate per Blinded Independent Central Review and investigator
Defined as the percentage of subjects who experience a best response of CR, PR or stable disease (SD)
Click on the lead sponsor to view all of their trials.
