Study of ZG006 in Participants With Neuroendocrine Prostate Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-80
SponsorSuzhou Zelgen Biopharmaceuticals Co.,Ltd

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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

Design model

Sequential

Treatments tested in this trial

  • ZG006

    Biological/Vaccine

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Part2Experimental treatment 1 intervention
Group B: Part 1Experimental treatment 1 intervention

Trial outcomes

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.

Time frame
Baseline to 12 months

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

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: