RecruitingPhase 1Phase 2NCT06283719

Dose Escalation Study of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by Dose Expansion Study in Participants With Advanced Small Cell Lung Cancer

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 Advanced Small Cell Lung Cancer


Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Enrollment

265 participants

Start Date

Sep 2, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multicenter, open-label Phase I/II study consisting of two parts: Part 1 is a Phase I dose-escalation study of ZG006, aimed at evaluating the safety and tolerability of ZG006 in Participants with advanced small-cell lung cancer or neuroendocrine carcinoma. Upon completion of Part 1, the investigators and sponsor will jointly determine two preliminary recommended Phase II doses for Part 2, based on the available safety, preliminary efficacy, and pharmacokinetic data. Part 2 is a Phase II dose-expansion study of ZG006, designed to explore and confirm the efficacy and safety of ZG006 monotherapy in advanced small-cell lung cancer.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new drug called ZG006 — an antibody-drug conjugate (a targeted therapy that delivers a cancer-killing agent directly to tumor cells) — for people with advanced small cell lung cancer (SCLC) or neuroendocrine carcinoma. SCLC is an aggressive form of lung cancer, and neuroendocrine carcinomas are tumors arising from hormone-producing cells. **You may be eligible if...** - You are between 18 and 75 years old - You are in good physical condition (ECOG 0-1) with a life expectancy of at least 3 months - You have been diagnosed with advanced small cell lung cancer OR neuroendocrine carcinoma (in the first dose-finding phase) - For the dose-expansion phase: you have advanced SCLC, either de-novo (never transformed) and on third-line or later, or transformed SCLC, or large-cell neuroendocrine carcinoma **You may NOT be eligible if...** - You have significant medical conditions that the investigator feels make participation unsafe - You do not meet the specific disease subtype requirements for your cohort 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)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

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NCT06283719


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