About this trial
This is a multicenter, open-label Phase II study, aimed at exploring the preliminary efficacy and safety of ZG006 in patients with advanced metastatic NEPC who have previously failed standard treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male Participants aged 18 to 80 years (inclusive);
Advanced metastatic neuroendocrine prostate cancer;
disease progression after at least one line of platinum-based systemic therapy or intolerance to toxicity;
Measurable disease according to RECIST v1.1 criteria;
Disqualifiers
Known positive test for human immunodeficiency virus (HIV) or hepatitis;
Patients were deemed unsuitable for participating in the study by the investigator for any reason.
Trial design
Sequential
Treatments tested in this trial
ZG006
Biological/VaccineZG006 will be administered as an intravenous (IV) infusion.
Treatment groups
Trial outcomes
Primary outcomes
Modified Best Overall Response(mBOR)
mBOR will be assessed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with Prostate Cancer Working Group 3 (PCWG3) modifications.
Secondary outcomes
Duration of Response (DOR)
Overall Survival (OS)
Disease Control Rate (DCR)
Adverse Events(AE)
Sponsors and contacts
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