This study is a randomized, open-label, controlled, multicenter phase II clinical trial, which aims to evaluate the safety and efficacy of SYS6002 versus enfortumab vedotin in the treatment of participants with advanced urothelial carcinoma.
This study has not yet been submitted for ethical review. The current registration is a pre-registration. Recruitment will be initiated only after formal approval is obtained from the relevant Ethics Committee or Institutional Review Board.
1. Patients aged 18-80 years (inclusive);
2. Pathologically confirmed patients with advanced urothelial carcinoma who have received a platinum-based chemotherapy with anti-PD-(L)1 agent. For those who received these therapies in the adjuvant or neoadjuvant setting, disease progression must have occurred during treatment or within 12 months of treatment completion;
3 An archival tumor tissue sample or a fresh tissue sample should be provided;
4 Subjects must have measurable disease according to RECIST (version 1.1);
1.Active central nervous system metastases or leptomeningeal metastasis;
2.Adverse events from prior anti-tumor therapy not recovered to ≤ Grade 1 (unless the investigator deems there is no safety risk)；
4.Use of other unmarketed clinical investigational drugs or treatments, chemotherapy, radiotherapy targeted therapy within 4 weeks prior to randomization; use of traditional Chinese medicine with anticancer indication, oral fluoropyrimidine drugs, small molecule targeted drug within 2 weeks prior to randomization; use of palliative radiation or local therapy within 2 weeks prior to randomization;with major surgery within 4 weeks prior to randomization;
5.Allergy to any component of SYS6002, or humanized monoclonal antibodies; investigator-determined ineligibility for enfortumab vedotin therapy.
Parallel
SYS6002
DrugSYS6002 by intravenous (IV)
enfortumab vedotin
Drug1.25 mg/kg by IV on Day 1、8、15, every 28 days.
Occurrence and frequency of Adverse Event (AE)
Incidence of treatment-related peripheral neuropathy and≥1-grade worsening in treatment-related peripheral neuropathy from baseline
Incidence of treatment-related hyperglycemia
Incidence of treatment-related cutaneous adverse reactions
Objective Response Rate (ORR)
Objective response rate is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) per RECIST v.1.1.
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