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.
A 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 Neuroendocrine Carcinoma.
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
78 participants
Aug 29, 2024
INTERVENTIONAL
Conditions
Summary
This is a multicenter, open-label phase I/II study, divided into 2 parts: 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.
Eligibility
Plain Language Summary
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This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
ZG006 will be administered as an intravenous (IV) infusion.
Locations(1)
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NCT06440057