Study of ZG006 in Participants With Neuroendocrine Prostate Cancer
NCT ID: NCT07024277
Last Updated: 2025-06-17
Study Results
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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NOT_YET_RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2025-08-31
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part2
Participants will receive the RP2D identified in Part 1 of the study.
ZG006
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.
ZG006
ZG006 will be administered as an intravenous (IV) infusion.
Interventions
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ZG006
ZG006 will be administered as an intravenous (IV) infusion.
Eligibility Criteria
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Inclusion Criteria
* 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
* Patients were deemed unsuitable for participating in the study by the investigator for any reason.
18 Years
80 Years
MALE
No
Sponsors
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Suzhou Zelgen Biopharmaceuticals Co.,Ltd
INDUSTRY
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ZG006-005
Identifier Type: -
Identifier Source: org_study_id
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