Neuroendocrine Prostate CancerPhase 2NCT07024277
Study of ZG006 in Participants With Neuroendocrine Prostate Cancer
A Phase 2 study testing ZG006 in people with Neuroendocrine Prostate Cancer, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Neuroendocrine Prostate Cancer
- What is being tested?
- ZG006
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Aug 2025to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fudan university shanghai cancer center
Shanghai, Shanghai Municipality
Dingwei Ye, dwyeli@163.com
About this study
Official title: A Phase II Study Evaluating the Preliminary Efficacy and Safety of ZG006 in Participants With Metastatic 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.
- Conditions
- Neuroendocrine Prostate Cancer
- Being tested
- ZG006
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZG006Biological
ZG006 will be administered as an intravenous (IV) infusion.
| Study group | Role | What they receive |
|---|---|---|
| Part2 | Experimental | Participants will receive the RP2D identified in Part 1 of the study. Receives: Biological: ZG006 |
| Part 1 | Experimental | 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. Receives: Biological: ZG006 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 12 months
Secondary outcomes (4)
Duration of Response (DOR)
Measured: Baseline to 12 months
Overall Survival (OS)
Measured: Baseline to 12 months
Disease Control Rate (DCR)
Measured: Baseline to 12 months
Adverse Events（AE）
Measured: Day 1 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study startAug 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine Prostate CancerStudies of the same condition, open and under way.
- More trials run by Suzhou Zelgen Biopharmaceuticals Co.,LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Wu, Study chair, Suzhou Zelgen Biopharmaceuticals Co.,Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024277
- Sponsor's protocol ID
- ZG006-005
- Status last verified
- Jun 2025
- First submitted
- 9 Jun 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Evaluating the Preliminary Efficacy and Safety of ZG006 in Participants With Metastatic Neuroendocrine Prostate Cancer
- ClinicalTrials.gov ID
- NCT07024277
- Acronym / sponsor ID
- ZG006-005
- Conditions
- Neuroendocrine Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part2 | Experimental | Biological: ZG006Participants will receive the RP2D identified in Part 1 of the study. |
| Part 1 | Experimental | Biological: ZG006The 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZG006ZG006 will be administered as an intravenous (IV) infusion. | Biological | Part 1, Part2 |
Primary outcome
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.
4 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jason Wu study chair
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ZG006 in people with Neuroendocrine Prostate Cancer, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shangdi Ning (+86-0512-57309965, ningsd@zelgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Best Overall Response（mBOR） (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.