A Phase 1 Dose Escalation Study of the Tolerability, Safety, Efficacy and Pharmacokinetics of ZG006 in Patients With Small Cell Lung Cancer
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.
Arms & interventions
- DrugZG006
ZG006 will be administered as an intravenous (IV) infusion.
Outcome measures
Primary
The incidence of dose-limiting toxicity (DLT)
An event is considered to be a DLT if the event occurs within the first 28 days of treatment and meets the dose-limiting toxicity criteria
Time frame: Up to 28 days
Maximum Tolerated Dose (MTD) of ZG006
Time frame: Approximately 2 years
Determine the Recommended Phase 2 Dose (RP2D)
Time frame: Approximately 2 years
Number of participants with adverse events (AEs)
The types and frequencies of adverse events (AEs) evaluated according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 5.0
Time frame: Approximately 2 years
Number of participants with serious adverse events (SAEs)
Time frame: Approximately 2 years
Incidence of abnormal laboratory results
Time frame: Approximately 2 years
Secondary
Objective response rate (ORR)
Time frame: Approximately 2 years
Duration of response (DOR)
Time frame: Approximately 2 years
Disease control rate (DCR)
Time frame: Approximately 2 years
Maximum plasma concentration (Cmax) of ZG006
Time frame: Approximately 2 years
Time to peak concentration (Tmax)
Time frame: Approximately 2 years
AUC from time zero to the last quantifiable concentration after dosing (AUC[0-t]) of ZG006
Time frame: Approximately 2 years
Terminal phase half-life (t1/2) of ZG006
Time frame: Approximately 2 years
Detection of anti-drug antibodies (ADA)
Time frame: Approximately 2 years
Eligibility criteria
Study locations (6)
Zelgen Site 105
Orange, California, 92868
Zelgen Site 102
Plantation, Florida, 33322
Zelgen Site 103
Lexington, Kentucky, 40536
Zelgen Site 101
Canton, Ohio, 44718
Zelgen Site 104
Cleveland, Ohio, 44106
Zelgen Site 106
Houston, Texas, 77030