Back to Trials
NCT06592638PHASE1Recruiting

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

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Start Date

3/31/2025

Completion Date

6/1/2027

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 Criteria

Age Range: 18 years to 75 years

Inclusion Criteria: * Small cell lung cancer (SCLC), who failed or intolerant to available standard treatments; * Tissue sample positive for DLL3 expression; * Life expectancy ≥ 3 months; * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; * Female and Male patients must agree to use a reliable form of contraception during the study treatment period and for at least 6 months after the last dose of the study drug. Exclusion Criteria: * Patients having received any of the following treatments: * Chemotherapy, biotherapy, endocrine therapy (except for hormone replacement), and biological targeted medicines ≤ 4 weeks before the study entry. Local palliative radiotherapy and a small molecule targeted therapy ≤ 2 weeks (or 5 half-lives, whichever is longer) before the study entry; * Systemic immunosuppressive medications, such as corticosteroid (doses \> 10 mg/day prednisone or equivalent dose) within 14 days prior to the study entry; * Use of any vaccines against viral infections (COVID-19, influenza, varicella, etc.) within 4 weeks of study entry; * Patients received any blood transfusion, EPO, G-CSF, albumin infusion and renal replacement therapy within 14 days prior to study entry; * A history of severe, life-threatening immune-mediated adverse events or infusion-related reactions during previous anti-tumor immunotherapy, including events that led to permanent discontinuation of treatment; * Active infection (such as acute bacterial infection, tuberculosis, active hepatitis B/C, active syphilis, or active human immunodeficiency virus infection); * Known allergy to other mAbs or any antibody excipients; the history of a severe allergic reaction, anaphylactoid or other hypersensitivity reactions to humanized antibodies or fusion proteins; * A female who is pregnant or nursing; * Patients were deemed unsuitable for participating in the study by the investigator for any reason.

Interventions

DRUG

ZG006

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Small Cell Lung Cancer

Locations

Zelgen Site 105

Orange, California 92868

United States

Zelgen Site 102

Plantation, Florida 33322

United States

Zelgen Site 103

Lexington, Kentucky 40536

United States

Zelgen Site 101

Canton, Ohio 44718

United States

Zelgen Site 104

Cleveland, Ohio 44106

United States

Zelgen Site 106

Houston, Texas 77030

United States