Status:
RECRUITING
A Phase 1 Dose Escalation Study of ZG006 in Patients With Small Cell Lung Cancer
Lead Sponsor:
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 treatmen...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06592638
Start Date
March 31 2025
End Date
June 1 2027
Last Update
August 6 2025
Active Locations (6)
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1
Zelgen Site 105
Orange, California, United States, 92868
2
Zelgen Site 102
Plantation, Florida, United States, 33322
3
Zelgen Site 103
Lexington, Kentucky, United States, 40536
4
Zelgen Site 101
Canton, Ohio, United States, 44718