ZG006 and ZG005 in Participants With Small Cell Lung Cancer or Neuroendocrine Carcinoma
NCT ID: NCT07038096
Last Updated: 2026-01-05
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
350 participants
INTERVENTIONAL
2025-09-23
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase Ib: Part1-Dose Escalation
This study will employ the traditional "3+3" dose escalation design. Ultimately, two combination dosing cohorts will be selected to enter Part 2, the dose expansion phase, based on a comprehensive evaluation of the safety and pharmacokinetic (PK) data obtained by the investigators and the sponsor.
ZG006
ZG006 will be administered as an intravenous (IV) infusion.
ZG005
ZG005 will be administered as an intravenous (IV) infusion.
Phase Ib: Part2-Dose Expansion
The safety and pharmacokinetic (PK) data obtained in Part 1 will be used to determine two expansion phase doses of the ZG006 and ZG005 combination. The dose expansion study will further evaluate the efficacy of the two selected combination dosing cohorts in patients with advanced small cell lung cancer and neuroendocrine carcinoma.
ZG006
ZG006 will be administered as an intravenous (IV) infusion.
ZG005
ZG005 will be administered as an intravenous (IV) infusion.
Phase II
Participants will receive the RP2D of ZG006 in combination with ZG005 identified in Phase Ib of the study.
ZG006
ZG006 will be administered as an intravenous (IV) infusion.
ZG005
ZG005 will be administered as an intravenous (IV) infusion.
Interventions
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ZG006
ZG006 will be administered as an intravenous (IV) infusion.
ZG005
ZG005 will be administered as an intravenous (IV) infusion.
Eligibility Criteria
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Inclusion Criteria
* Male or female 18-70 years of age.
* Participants with advanced small cell lung cancer or neuroendocrine carcinoma confirmed by histopathology or cytology.
* Eastern Cooperative Oncology Group (ECOG) 0 to 1.
* Life expectancy \> 3 months.
Exclusion Criteria
18 Years
70 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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Sun Yat-sen University Cancer Center
Guanzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Li Zhang
Role: primary
Other Identifiers
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ZG006-ZG005-001
Identifier Type: -
Identifier Source: org_study_id
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