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RecruitingInterventionalPhase 1

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

NCT ID: NCT06592638Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,LtdLast updated: 2025-08-06

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.

Arms & interventions

  • DrugZG006

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

Outcome measures

Primary

  • The incidence of dose-limiting toxicity (DLT)

    An event is considered to be a DLT if the event occurs within the first 28 days of treatment and meets the dose-limiting toxicity criteria

    Time frame: Up to 28 days

  • Maximum Tolerated Dose (MTD) of ZG006

    Time frame: Approximately 2 years

  • Determine the Recommended Phase 2 Dose (RP2D)

    Time frame: Approximately 2 years

  • Number of participants with adverse events (AEs)

    The types and frequencies of adverse events (AEs) evaluated according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 5.0

    Time frame: Approximately 2 years

  • Number of participants with serious adverse events (SAEs)

    Time frame: Approximately 2 years

  • Incidence of abnormal laboratory results

    Time frame: Approximately 2 years

Secondary

  • Objective response rate (ORR)

    Time frame: Approximately 2 years

  • Duration of response (DOR)

    Time frame: Approximately 2 years

  • Disease control rate (DCR)

    Time frame: Approximately 2 years

  • Maximum plasma concentration (Cmax) of ZG006

    Time frame: Approximately 2 years

  • Time to peak concentration (Tmax)

    Time frame: Approximately 2 years

  • AUC from time zero to the last quantifiable concentration after dosing (AUC[0-t]) of ZG006

    Time frame: Approximately 2 years

  • Terminal phase half-life (t1/2) of ZG006

    Time frame: Approximately 2 years

  • Detection of anti-drug antibodies (ADA)

    Time frame: Approximately 2 years

Eligibility criteria

Sex: AllAge: 18 Years to 75 YearsHealthy volunteers: No
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.

Study locations (6)

Zelgen Site 105

Orange, California, 92868

Not Yet Recruiting

Zelgen Site 102

Plantation, Florida, 33322

Recruiting

Zelgen Site 103

Lexington, Kentucky, 40536

Recruiting

Zelgen Site 101

Canton, Ohio, 44718

Recruiting

Zelgen Site 104

Cleveland, Ohio, 44106

Not Yet Recruiting

Zelgen Site 106

Houston, Texas, 77030

Not Yet Recruiting
A Phase 1 Dose Escalation Study of ZG006 in Patients With Small Cell Lung Cancer | Cancerify