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OncoMatch/Clinical Trials/NCT06592638

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

Is NCT06592638 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies ZG006 for small cell lung cancer.

Phase 1RecruitingSuzhou Zelgen Biopharmaceuticals Co.,LtdNCT06592638Data as of May 2026

Treatment: ZG006This 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.

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Extracted eligibility criteria

Cancer type

Small Cell Lung Cancer

Biomarker criteria

Required: DLL3 expression (positive)

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: standard treatments

who failed or intolerant to available standard treatments

Cannot have received: chemotherapy

Chemotherapy ... ≤ 4 weeks before the study entry

Cannot have received: biotherapy

biotherapy ... ≤ 4 weeks before the study entry

Cannot have received: endocrine therapy

Exception: except for hormone replacement

endocrine therapy (except for hormone replacement) ... ≤ 4 weeks before the study entry

Cannot have received: biological targeted medicines

biological targeted medicines ≤ 4 weeks before the study entry

Cannot have received: local palliative radiotherapy

Local palliative radiotherapy ... ≤ 2 weeks (or 5 half-lives, whichever is longer) before the study entry

Cannot have received: small molecule targeted therapy

small molecule targeted therapy ≤ 2 weeks (or 5 half-lives, whichever is longer) before the study entry

Cannot have received: systemic immunosuppressive medications (corticosteroid)

Exception: doses > 10 mg/day prednisone or equivalent dose within 14 days prior to 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

Cannot have received: vaccines against viral infections (COVID-19, influenza, varicella)

Use of any vaccines against viral infections (COVID-19, influenza, varicella, etc.) within 4 weeks of study entry

Cannot have received: blood transfusion

Patients received any blood transfusion ... within 14 days prior to study entry

Cannot have received: EPO

Patients received any ... EPO ... within 14 days prior to study entry

Cannot have received: G-CSF

Patients received any ... G-CSF ... within 14 days prior to study entry

Cannot have received: albumin infusion

Patients received any ... albumin infusion ... within 14 days prior to study entry

Cannot have received: renal replacement therapy

Patients received any ... renal replacement therapy within 14 days prior to study entry

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Zelgen Site 105 · Orange, California
  • Zelgen Site 102 · Plantation, Florida
  • Zelgen Site 103 · Lexington, Kentucky
  • Zelgen Site 101 · Canton, Ohio
  • Zelgen Site 104 · Cleveland, Ohio

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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