Study of ZG006 in Participants With Neuroendocrine Prostate Cancer

NCT ID: NCT07024277

Last Updated: 2025-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2027-12-31

Brief Summary

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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

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Conditions

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Neuroendocrine Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part2

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

Group Type EXPERIMENTAL

ZG006

Intervention Type BIOLOGICAL

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

Part 1

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.

Group Type EXPERIMENTAL

ZG006

Intervention Type BIOLOGICAL

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

Interventions

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ZG006

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Suzhou Zelgen Biopharmaceuticals Co.,Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jason Wu

Role: STUDY_CHAIR

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Locations

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Fudan university shanghai cancer center

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Shangdi Ning

Role: CONTACT

+86-0512-57309965

Facility Contacts

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Dingwei Ye

Role: primary

Other Identifiers

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ZG006-005

Identifier Type: -

Identifier Source: org_study_id

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