RecruitingPhase 1NCT06592638

A Phase 1 Dose Escalation Study of ZG006 in Patients With Small Cell Lung Cancer

A Phase 1 Dose Escalation Study of the Tolerability, Safety, Efficacy and Pharmacokinetics of ZG006 in Patients With Small Cell Lung Cancer


Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Enrollment

30 participants

Start Date

Mar 31, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multi-center, open-label, Phase 1 clinical study of ZG006 in the US for the treatment of subjects with small cell lung cancer who have failed or are intolerant to available standard treatment. During the dose escalation stage, a standard "3+3" design will be used to assess the MTD/ recommended dose for the subsequent studies.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This is an early-phase safety study testing a new drug called ZG006 in people with small cell lung cancer whose disease has stopped responding to standard treatments. The goal is to find the right dose and check safety. **You may be eligible if...** - You have been diagnosed with small cell lung cancer that has not responded to, or you could not tolerate, standard treatments - Your tumor tests positive for a protein called DLL3 - Your life expectancy is at least 3 months - You are generally well enough to be up and about most of the day (ECOG score 0 or 1) - You are willing to use contraception during treatment and for 6 months after **You may NOT be eligible if...** - You received chemotherapy or other cancer drugs within the past 4 weeks - You have been on high-dose steroids (more than 10 mg prednisone daily) within the past 2 weeks - You received a vaccine (COVID, flu, etc.) within the past 4 weeks - You have had a severe, life-threatening reaction to a previous immunotherapy - You have an active infection such as hepatitis B/C, HIV, or tuberculosis - 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

DRUGZG006

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


Locations(6)

Zelgen Site 105

Orange, California, United States

Zelgen Site 102

Plantation, Florida, United States

Zelgen Site 103

Lexington, Kentucky, United States

Zelgen Site 101

Canton, Ohio, United States

Zelgen Site 104

Cleveland, Ohio, United States

Zelgen Site 106

Houston, Texas, United States

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NCT06592638


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