NCT07024277

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
19mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Aug 2025Dec 2027

First Submitted

Initial submission to the registry

June 9, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 17, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

June 17, 2025

Status Verified

June 1, 2025

Enrollment Period

2.3 years

First QC Date

June 9, 2025

Last Update Submit

June 9, 2025

Conditions

Neuroendocrine Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline to 12 months

Secondary Outcomes (4)

  • 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

Study Arms (2)

Part2

EXPERIMENTAL

Participants will receive the RP2D identified in Part 1 of the study.

Biological: ZG006

Part 1

EXPERIMENTAL

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.

Biological: ZG006

Interventions

ZG006BIOLOGICAL

ZG006 will be administered as an intravenous (IV) infusion.

Part 1Part2

Eligibility Criteria

Age18 Years - 80 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan university shanghai cancer center

Shanghai, Shanghai Municipality, China

Location

Study Officials

  • Jason Wu

    Suzhou Zelgen Biopharmaceuticals Co.,Ltd

    STUDY CHAIR

Central Study Contacts

Shangdi Ning

CONTACT

+86-0512-57309965ningsd@zelgen.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2025

First Posted

June 17, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

June 17, 2025

Record last verified: 2025-06

Locations

CN(1)