Neuroendocrine Prostate Cancer
Conditions
Brief 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.
Interventions
BIOLOGICALZG006
ZG006 will be administered as an intravenous (IV) infusion.
Sponsors
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response (DOR) | Baseline to 12 months |
| Overall Survival (OS) | Baseline to 12 months |
| Disease Control Rate (DCR) | Baseline to 12 months |
| Adverse Events（AE） | Day 1 to 12 months |
Countries
China
Contacts
Primary ContactShangdi Ning
Outcome results
None listed