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RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Fully understand the study and voluntarily sign the willing to sign a consent form form; - Male or female 18\~75 years of age; - Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1; - Life expectancy ≥ 3 months. Who Should NOT Join This Trial: - Participants were deemed unsuitable for participating in the study by the investigator for any reason. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 Criteria: * Participants were deemed unsuitable for participating in the study by the investigator for any reason.

Treatments Being Tested

BIOLOGICAL

ZG006

ZG006 will be administered as an intravenous (IV) infusion.

Locations (1)

Chinese PLA General Hospital
Beijing, Beijing Municipality, China