Not yet recruiting NCT07024277
Study of ZG006 in Participants With Neuroendocrine Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ZG006.
- Who it may be relevant to
- Registry conditions: Neuroendocrine Prostate Cancer. Basic parameters: 18 years — 80 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase II Study Evaluating the Preliminary Efficacy and Safety of ZG006 in Participants With Metastatic Neuroendocrine Prostate Cancer
Overview
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.
Interventions
- Biological ZG006
ZG006 will be administered as an intravenous (IV) infusion.
Primary outcome measures
- Modified Best Overall Response（mBOR） [Time frame: Baseline to 12 months]
Secondary outcome measures (4)
- Duration of Response (DOR) [Time frame: Baseline to 12 months]
- Overall Survival (OS) [Time frame: Baseline to 12 months]
- Disease Control Rate (DCR) [Time frame: Baseline to 12 months]
- Adverse Events（AE） [Time frame: Day 1 to 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fudan university shanghai cancer center — Shanghai
Identifiers
NCT: NCT07024277 · ZG006-005