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
Inclusion Criteria4
- Fully understand the study and voluntarily sign the informed consent form;
- Male or female 18\~75 years of age;
- Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1;
- Life expectancy ≥ 3 months.
Exclusion Criteria1
- Participants were deemed unsuitable for participating in the study by the investigator for any reason.
Interventions
ZG006 will be administered as an intravenous (IV) infusion.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06440057