The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG006A in patients with advanced solid tumors.
This study consists of two parts. Phase I is a dose escalation study to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of MRG006A. Phase II is a dose expansion study to further assess the efficacy, safety, pharmacokinetics and immunogenicityof MRG006A at confirmed RP2D.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
343
Administrated intravenously
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGZhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGMaximum Tolerated Dose (MTD) - Phase I
The highest dose confirmed wherein less than 2 out of 6, or \< 33% of evaluable patients in a treatment cohort experiences dose-limiting toxicity (DLT).
Time frame: Baseline to the end of the first treatment cycle (each cycle is 21 days).
Recommended Phase II Dose (RP2D) - Phase I
The dose level of MRG006A recommended for further clinical studies based on assessment of the safety, efficacy and PK data from this study.
Time frame: Baseline to study completion (up to 24 months).
Adverse Events (AEs) - Phase I
Any reaction, side effect, or untoward event that occurs during the course of the clinical trial whether or not the event is considered related to the study drug.
Time frame: Baseline to 30 days after the last dose of study treatment.
Serious Adverse Events (SAEs) - Phase I
Adverse events that are fatal, life-threatening, or result in hospitalization or prolonged hospitalization, persistent or significant disability/incapacity/substantial disruption of the ability to lead a normal life, congenital anomaly/birth defect or major medical events or reactions.
Time frame: Baseline to 30 days after the last dose of study treatment.
Objective Response Rate (ORR)- Phase II
ORR is defined as the proportion of subjects with CR and PR assessed by IRC and investigator according to RECIST v1.1 and mRECIST(HCC patients). And determine the objective response rate (CR + PR) and its 95% confidence interval.
Time frame: Baseline to study completion (up to 24 months).
Objective Response Rate (ORR) - Phase I
ORR is defined as the proportion of subjects with CR and PR assessed by IRC and investigator according to RECIST v1.1 and mRECIST(HCC patients). And determine the objective response rate (CR + PR) and its 95% confidence interval.
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Time frame: Baseline to study completion (up to 24 months).
Overall Survive (OS)- Phase II
The time from start of study treatment to date of death as a result of any cause.
Time frame: Baseline to study completion (up to 24 months).
Duration of Response (DoR)
The time interval between the date of the earliest qualifying response and the date of disease progression or death for any cause, whichever occurs earlier.
Time frame: Baseline to study completion (up to 24 months).
Disease Control Rate (DCR)
The proportion of patients who achieve CR, PR, or stable disease (SD) after treatment.
Time frame: Baseline to study completion (up to 24 months).
Progression Free Survival (PFS)
The time from the date of first study dose to disease progression or death whichever occurs first.
Time frame: Baseline to study completion (up to 24 months).
Cmax
Maximum observed blood concentration
Time frame: Baseline to 30 days after the last dose of study treatment.
Tmax
Time to reach the maximum blood concentration.
Time frame: Baseline to 30 days after the last dose of study treatment.
AUC0-t
Area under the blood concentration-time curve from time 0 to the time of last quantifiable concentration.
Time frame: Baseline to 30 days after the last dose of study treatment.
Incidence of anti-drug antibody (ADA)
The proportion of patients with positive ADA results.
Time frame: Baseline to 30 days after the last dose of study treatment.
QT interval corrected by Fridericia's formula(QTcF)
Evaluate the effect of MRG006A on the prolongation of QT interval corrected by heart rate using Fridericia's formula (QTcF) in patients with advanced solid tumors.
Time frame: Baseline to 15 days after the third dose of study treatment.
Adverse Events (AEs) - Phase II
Any reaction, side effect, or untoward event that occurs during the course of the clinical trial whether or not the event is considered related to the study drug.
Time frame: Baseline to 30 days after the last dose of study treatment.
Serious Adverse Events (SAEs) - Phase II
Adverse events that are fatal, life-threatening, or result in hospitalization or prolonged hospitalization, persistent or significant disability/incapacity/substantial disruption of the ability to lead a normal life, congenital anomaly/birth defect or major medical events or reactions.
Time frame: Baseline to 30 days after the last dose of study treatment.