Study of ZG006 in Participants With Neuroendocrine Prostate Cancer

Phase 2Not Yet RecruitingNCT07024277

Suzhou Zelgen Biopharmaceuticals Co.,Ltd60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neuroendocrine Prostate Cancer

Interventions

ZG006BIOLOGICAL

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

Eligibility

Sex: MALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Fudan university shanghai cancer center

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

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.

Time frame: Baseline to 12 months

Secondary Outcomes

Duration of Response (DOR)

Time frame: Baseline to 12 months

Overall Survival (OS)

Time frame: Baseline to 12 months

Disease Control Rate (DCR)

Time frame: Baseline to 12 months

Adverse Events（AE）

Time frame: Day 1 to 12 months

Central Contacts

Shangdi Ning

CONTACT

+86-0512-57309965 ningsd@zelgen.com

Data from ClinicalTrials.gov

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