The objective of this study is to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of MRG004A in patients with Tissue Factor positive advanced or metastatic solid tumors.
This study consists of two parts. Part A is a dose escalation study to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of MRG004A. Part B is a disease specific multi-cohort dose expansion study to further assess the efficacy and safety of MRG004A at confirmed RP2D.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Administrated intravenously
Chao Family Comprehensive Cancer Center
Orange, California, United States
Memorial Sloan Kettering 60th Street Outpatient Center
New York, New York, United States
Gabrail Cancer Center Research
Canton, Ohio, United States
Maximum Tolerated Dose (MTD)
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: DLT will be evaluated during the first treatment cycle (Day 1-21)
Recommended Phase II Dose (RP2D)
The dose level of MRG004A recommended for further clinical studies based on assessment of the safety, efficacy and PK data from Part A of this study.
Time frame: Baseline to study completion (up to 24 months)
Objective Response Rate (ORR)
The proportion of patients who achieve complete response (CR) or partial response (PR) as assessed by the Independent Central Review (ICR).
Time frame: Baseline to study completion (up to 24 months)
Adverse Events (AEs)
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: From signing informed consent until 45 days after the last dose of MRG004A
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) ≥ 6 weeks based on RECIST v1.1.
Time frame: Baseline to study completion (up to 24 months)
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The Christ Hospital Cancer Center
Cincinnati, Ohio, United States
Gettysburg Cancer Center
Gettysburg, Pennsylvania, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Hunan Cancer Hospital
Changsha, Hunan, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
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)
Overall Survive (OS)
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)
Pharmacokinetics (PK) Parameter of MRG004A: Cmax
Maximum observed plasma concentration.
Time frame: Baseline to 30 days after the last dose of study treatment
Pharmacokinetics (PK) Parameter of MRG004A: Tmax
Time to reach the maximum plasma concentration.
Time frame: Baseline to 30 days after the last dose of study treatment
Pharmacokinetics (PK) Parameter of MRG004A: AUClast
Area under the plasma 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 immunogenicity results.
Time frame: Baseline to 30 days after the last dose of study treatment