ZG006: ZG006 will be administered as an intravenous (IV) infusion.
Study summary
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
Sex
MALE
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* 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;
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
Modified Best Overall Response（mBOR） — Baseline to 12 months mBOR will be assessed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with Prostate Cancer Working Group 3 (PCWG3) modifications.
Trial sites (1)
Facility
City
Region
Status
Fudan university shanghai cancer center
Shanghai
Shanghai Municipality
More Suzhou Zelgen Biopharmaceuticals Co.,Ltd trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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