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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
ZG006 will be administered as an intravenous (IV) infusion.
Zelgen Site 105
Orange, California, United States
NOT_YET_RECRUITINGZelgen Site 102
Plantation, Florida, United States
RECRUITINGZelgen Site 103
Lexington, Kentucky, United States
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
Objective response rate (ORR)
ORR is defined as the percentage of participants achieving a confirmed complete response (CR) or partial response (PR) based on RECIST 1.1 criteria.
Time frame: Approximately 2 years
Duration of response (DOR)
DOR is defined as the time from first evidence of response (CR or PR per RECIST 1.1) to earlier date of disease progression or death due to any cause
Time frame: Approximately 2 years
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Zelgen Site 101
Canton, Ohio, United States
RECRUITINGZelgen Site 104
Cleveland, Ohio, United States
NOT_YET_RECRUITINGZelgen Site 106
Houston, Texas, United States
NOT_YET_RECRUITINGDisease 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