Dose Escalation Study of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by Dose Expansion Study in Participants With Neuroendocrine Carcinoma.
NCT ID: NCT06440057
Last Updated: 2024-12-16
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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RECRUITING
PHASE1/PHASE2
78 participants
INTERVENTIONAL
2024-08-29
2026-07-31
Brief Summary
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Part 1 involves a dose-escalation study of ZG006 in which the safety and tolerability of ZG006 in patients with advanced small cell lung cancer or neuroendocrine carcinoma are explored. Upon completion of Part 1, investigators and the sponsor will discuss and determine two recommended phase II doses (RP2D) based on safety, preliminary efficacy, and pharmacokinetic results for use in Part 2.
Part 2 is a phase II dose-expansion study of ZG006, aiming to investigate the efficacy and safety of ZG006 in patients with Neuroendocrine Carcinoma.
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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Dose Escalation
A total of six dose escalations were preset: 0.1 mg, 0.3 mg, 1 mg, 3 mg.
ZG006
ZG006 will be administered as an intravenous (IV) infusion.
Dose Expansion
Participants will receive the RP2D identified in Dose Escalation Study .
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
* Male or female 18\~75 years of age;
* Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1;
* Life expectancy ≥ 3 months.
Exclusion Criteria
18 Years
75 Years
ALL
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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Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Jianming Xu
Role: primary
Other Identifiers
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ZG006-003
Identifier Type: -
Identifier Source: org_study_id