RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-03-31

Study Completion:2027-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06592638

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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 \&gt; 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.

Inclusion Criteria

Exclusion 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.

* 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 \&gt; 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.

Contacts and Locations

Study Contact

Zelgen

CONTACT

+86-02158942758

liusc@zelgen.com

Study Locations (Sites)

Zelgen Site 102

Plantation, Florida, 33322

United States

Zelgen Site 101

Canton, Ohio, 44718

United States

Collaborators and Investigators

Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-31

Study Completion Date2027-06

Study Record Updates

Study Start Date2025-03-31

Study Completion Date2027-06

Terms related to this study

Additional Relevant MeSH Terms

Small Cell Lung Cancer