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NCT Number: NCT07024277

Study of ZG006 in Participants With Neuroendocrine Prostate Cancer

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.

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Key information

Conditions

Neuroendocrine Prostate Cancer

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Fudan university shanghai cancer center

Shanghai, Shanghai Municipality, China

Location contact

Dingwei Ye

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ZG006

Biological

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

Primary outcomes

  1. Modified Best Overall Response（mBOR）

    Time frame: 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 outcomes

  1. Duration of Response (DOR)

    Time frame: Baseline to 12 months

  2. Overall Survival (OS)

    Time frame: Baseline to 12 months

  3. Disease Control Rate (DCR)

    Time frame: Baseline to 12 months

  4. Adverse Events（AE）

    Time frame: Day 1 to 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Shangdi Ning

CONTACT

[email protected]

+86-0512-57309965

Sponsors and collaborators

Lead sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Industry

Registry information

Official study title

A Phase II Study Evaluating the Preliminary Efficacy and Safety of ZG006 in Participants With Metastatic Neuroendocrine Prostate Cancer

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 17, 2025
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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