Study of ZG006 in Participants With Neuroendocrine Prostate Cancer

Phase 2

Not yet recruiting

• Conditions: Neuroendocrine Prostate Cancer
• Interventions: Biological: ZG006

• Registration Number: NCT07024277
• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-09
• Study First Submitted QC: 2025-06-09
• Last Update Submitted: 2025-06-09
• Study First Posted: 2025-06-17
• Last Update Posted: 2025-06-17
• Study Start: 2025-08
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part2	ZG006	Participants will receive the RP2D identified in Part 1 of the study.
Part 1	ZG006	The preliminary efficacy and safety of ZG006 at the two determined potential Phase II recommended doses (10 mg and 30 mg) will be assessed in Participants with advanced metastatic NEPC.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Fudan university shanghai cancer center; 🇨🇳 Shanghai, Shanghai, China