Study of ZG006 in Participants With Neuroendocrine Prostate Cancer

Zelgen Biopharmaceuticals

Status and phase: Not yet enrolling; Phase 2

Conditions: Neuroendocrine Prostate Cancer

Treatments: Biological: ZG006

Study type: Interventional

Funder types: Industry

Identifiers

NCT07024277

ZG006-005

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Part2

Experimental group

Description:

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

Treatment:

Biological: ZG006

Part 1

Experimental group

Description:

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.

Treatment:

Biological: ZG006