A Phase 1 Dose Escalation Study of the Tolerability, Safety, Efficacy and Pharmacokinetics of ZG006 in Patients With Small Cell Lung Cancer
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
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.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
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 replaceme…
Interventions
- DrugZG006
ZG006 will be administered as an intravenous (IV) infusion.
Locations (6)
- Zelgen Site 105Orange, California
- Zelgen Site 102Plantation, Florida
- Zelgen Site 103Lexington, Kentucky
- Zelgen Site 101Canton, Ohio
- Zelgen Site 104Cleveland, Ohio
- Zelgen Site 106Houston, Texas