At a glance
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NCT06283719Phase 2RecruitingMonitorUpdated 7mo ago · Completion was 3mo agoA Phase I Dose Escalation Study of Tolerability, Safety, Efficacy, and Pharmacokinetics of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by a Phase II Dose Expansion Study in Participants With Advanced Small Cell Lung Cancer
In Brief
A Phase 2 clinical trial evaluating ZG006 for Small Cell Lung Cancer and Neuroendocrine Cancer. Currently recruiting, targeting 265 participants across 1 site.
Signals
Detailed Summary
This is a multicenter, open-label Phase I/II study consisting of two parts: Part 1 is a Phase I dose-escalation study of ZG006, aimed at evaluating the safety and tolerability of ZG006 in Participants with advanced small-cell lung cancer or neuroendocrine carcinoma. Upon completion of Part 1, the investigators and sponsor will jointly determine two preliminary recommended Phase II doses for Part 2, based on the available safety, preliminary efficacy, and pharmacokinetic data. Part 2 is a Phase II dose-expansion study of ZG006, designed to explore and confirm the efficacy and safety of ZG006 monotherapy in advanced small-cell lung cancer.
Study Details
Timeline
Interventions
ZG006 will be administered as an intravenous (IV) infusion.