RecruitingPhase 1Phase 2NCT06440057

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.


Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Enrollment

78 participants

Start Date

Aug 29, 2024

Study Type

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests ZG006, a new targeted treatment for people with advanced small cell lung cancer or neuroendocrine carcinoma — rare but aggressive cancers that often come back after initial treatment. The study first checks the safest dose and then expands to test effectiveness. **You may be eligible if...** - You are between 18 and 75 years old - You have advanced small cell lung cancer or neuroendocrine carcinoma - You are in reasonably good physical condition (able to carry out normal activities with minimal assistance) - Your life expectancy is at least 3 months **You may NOT be eligible if...** - Your cancer has spread to the brain and is untreated or unstable - You have serious heart, liver, or kidney problems - You have had major surgery or another investigational drug treatment recently - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

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

BIOLOGICALZG006

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


Locations(1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

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NCT06440057


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