This study is an open-label, dose-escalation and cohort expansion Phase I study, aiming to evaluate the safety, tolerability, PK characteristics and preliminary efficacy of ESG406, and determine the MTD, RP2D and administration regimens of ESG406. The study includes the dose escalation study in Phase Ia and the cohort expansion study in Phase Ib.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
556
Administered via intravenous (IV) infusion.
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
RECRUITINGThe First Affiliated Hospital of Xi 'An Jiaotong University
Xi’an, Shanxi, China
RECRUITINGThe Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGPercentage of Participants Experiencing Any Treatment Emergent Adverse Events and Serious Treatment Emergent Adverse Events
Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 5.0. An AE that met one or more of the following outcomes was classified as serious: Fatal Life-threatening Disabling/incapacitating Results in hospitalization or prolongs a hospital stay A congenital abnormality Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above.
Time frame: First dose date up to last dose plus 30 days
Objective Response Rate
Objective Response Rate(ORR) is defined as the rate an overall best response of either complete response (CR) or partial response (PR) .
Time frame: Up to approximately 36 months.
Progression Free Survival
Progression-free survival (PFS) is defined as the interval from the first dose start date to the date of disease progression defined as documented progressive disease (PD) or death from any cause, whichever occurs first.
Time frame: Up to approximately 36 months.
Cmax
Maximum observed plasma concentration
Time frame: Up to approximately 36 months.
AUC0-inf
Area under the serum concentration time curve from time 0 extrapolated to infinity
Time frame: Up to approximately 36 months.
T1/2
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Half-life
Time frame: Up to approximately 36 months.
Anti-drug Antibodies
Incidence of anti-drug antibodies
Time frame: Up to approximately 36 months.