Actively Recruiting
A Phase 1 Dose Escalation Study of the Tolerability, Safety, Efficacy and Pharmacokinetics 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
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a multi-center, open-label Phase 1 clinical trial to study ZG006 in people with small cell lung cancer who have not responded to or cannot tolerate existing standard treatments. The study aims to find the maximum tolerated dose and recommended dose for further research, focusing on safety, tolerability, and how the drug behaves in the body. This early phase trial uses a dose escalation design to carefully evaluate dosing levels. ZG006 is given to participants as an intravenous infusion. The trial follows a standard "3+3" dose escalation approach during which different doses are tested to determine the best dose for future studies. This phase includes monitoring for dose-limiting toxicities and adverse events to assess safety. The study is expected to last about two years for evaluating dosing and safety outcomes. Participants will be monitored closely with various assessments including laboratory tests to detect side effects and the presence of anti-drug antibodies. Researchers will measure how the drug is processed in the body, its concentration over time, and its effects on tumor response. The study includes regular safety checks and follows participants for up to two years to gather comprehensive data on treatment effects and tolerability.
CONDITIONS
Brief 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...
- Small cell lung cancer patients who have failed or are intolerant to available 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
- Female and male patients must agree to use reliable contraception during treatment and for at least 6 months after the last dose
You will not qualify if you...
- Received chemotherapy, biotherapy, endocrine therapy (except hormone replacement), or biological targeted medicines within 4 weeks before study entry
- Had local palliative radiotherapy or small molecule targeted therapy within 2 weeks or 5 half-lives before study entry
- Taken systemic immunosuppressive medications (e.g., corticosteroids over 10 mg/day prednisone) within 14 days prior to study entry
- Used vaccines against viral infections within 4 weeks prior to study entry
- Received blood transfusion, EPO, G-CSF, albumin infusion, or renal replacement therapy within 14 days prior to study entry
- History of severe immune-mediated adverse events or infusion reactions from prior immunotherapy
- Active infections such as acute bacterial infection, tuberculosis, active hepatitis B/C, active syphilis, or HIV infection
- Known allergy to monoclonal antibodies or antibody excipients
- Female who is pregnant or nursing
- Deemed unsuitable for participation by the investigator for any reason
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days for dose-limiting toxicity assessment; treatment and monitoring may continue for up to approximately 2 years
Participants receive ZG006 administered as an intravenous infusion to evaluate its tolerability, safety, and efficacy.
Regular visits during treatment and monitoring period
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
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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