Recruiting
Phase 1

ZG006

Sponsor:

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Code:

NCT06592638

Conditions

Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

ZG006

Study Details

Brief 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.

Conditions

Small Cell Lung Cancer

Study ID

NCT06592638

Start date

Mar 31, 2025

Status verified date

Apr, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Escalation

Interventions

ZG006

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

Primary outcome measure

  • The incidence of dose-limiting toxicity (DLT) [ 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) [ 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 ]

Central Contacts and Locations

Central contacts

Zelgen

+86-02158942758liusc@zelgen.com

Locations

Zelgen Site 102

Recruiting

Plantation, Florida, United States, 33322

Zelgen Site 103

Recruiting

Lexington, Kentucky, United States, 40536

Zelgen Site 101

Recruiting

Canton, Ohio, United States, 44718

More Information

Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Last update posted

Aug 6, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Suzhou Zelgen Biopharmaceuticals Co.,Ltd on 2025-08-06.