Actively Recruiting
A Phase 1 Dose Escalation Study of ZG006 in Patients With Small Cell Lung Cancer
Led by Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Updated on 2025-08-06
30
Participants Needed
6
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Phase 1 Dose Escalation Study of ZG006 in Patients With Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Diagnosed with small cell lung cancer who failed or are intolerant to standard treatments
- Tissue sample positive for DLL3 expression
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Agree to use reliable contraception during treatment and for 6 months after last dose
You will not qualify if you...
- Received chemotherapy, biotherapy, endocrine therapy (except hormone replacement), or targeted biological medicines within 4 weeks before study start
- Received local palliative radiotherapy or small molecule targeted therapy within 2 weeks before study start
- Taken systemic immunosuppressive medications like corticosteroids (>10 mg/day prednisone or equivalent) within 14 days before study start
- Received any vaccines against viral infections within 4 weeks before study start
- Had blood transfusions, EPO, G-CSF, albumin infusion, or renal replacement therapy within 14 days before study start
- History of severe immune-related adverse events or infusion reactions from previous anti-tumor immunotherapy
- Active infections such as bacterial infections, tuberculosis, active hepatitis B/C, syphilis, or HIV
- Known allergy to monoclonal antibodies or antibody components
- Pregnant or nursing females
- Deemed unsuitable for participation by the investigator for any reason
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
Zelgen Site 105
Orange, California, United States, 92868
Not Yet Recruiting
2
Zelgen Site 102
Plantation, Florida, United States, 33322
Actively Recruiting
3
Zelgen Site 103
Lexington, Kentucky, United States, 40536
Actively Recruiting
4
Zelgen Site 101
Canton, Ohio, United States, 44718
Actively Recruiting
5
Zelgen Site 104
Cleveland, Ohio, United States, 44106
Not Yet Recruiting
6
Zelgen Site 106
Houston, Texas, United States, 77030
Not Yet Recruiting
Research Team
Z
Zelgen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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