This is an open-label, multi-center, phase I study to evaluate the safety, tolerability, efficacy, and pharmacokinetics of MRG007 (ARR-217) in patients with unresectable locally advanced or metastatic solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
572
MRG007 will be administrated as specified in the protocol.
MRG007 will be administered as specified in the protocol
ULCA
Los Angeles, California, United States
Dose Limiting Toxicity (DLT) - Phase Ia
Time frame: Baseline to Day 21 of the first treatment cycle
Serious Adverse Events (SAEs)
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
Treatment-Emergent Adverse Event (TEAE)
AEs that occur or worsen on or after the first dose of study treatment
Time frame: Baseline to 30 days after the last dose of study treatment
Treatment-Related Adverse Event
Any reaction, side effect, or untoward event that occurs during the course of the clinical trial is considered related to the study drug.
Time frame: Baseline to 30 days after the last dose of study treatment
Objective Response Rate (ORR) as assessed by investigator - Phase Ib
ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR). ORR will be assessed according to RECIST v1.1.
Time frame: Baseline to study completion (up to 24 months)
Objective Response Rate (ORR) - Phase Ia
ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR). ORR will be assessed according to RECIST v1.1.
Time frame: Baseline to study completion (up to 24 months)
Disease Control Rate (DCR)
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UCSF
San Francisco, California, United States
RECRUITINGUniversity of Colorado
Aurora, Colorado, United States
RECRUITINGSarah Cannon Research Institute
Denver, Colorado, United States
RECRUITINGSarah Cannon Research Institute
Sarasota, Florida, United States
RECRUITINGSarah Cannon Research Institute
Nashville, Tennessee, United States
RECRUITINGMD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGNEXT Dallas
Irving, Texas, United States
RECRUITINGNEXT Virginia
Fairfax, Virginia, United States
RECRUITINGFred Hutchinson Cancer Center
Seattle, Washington, United States
RECRUITING...and 11 more locations
DCR is defined as the proportion of subjects achieving CR, PR, and stable disease (SD) after treatment.
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)
Progression Free Survival (PFS) as assessed by investigator
PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.
Time frame: Baseline to study completion (up to 24 months)
Overall Survival (OS)
OS is defined as the duration from the start of treatment to death of any cause.
Time frame: Baseline to study completion (up to 24 months)
Incidence of anti-drug antibody (ADA)
The proportion of patients with positive ADA results.
Time frame: Baseline to 30 days after the last dose.
Incidence of neutralizing antibody (NAb)
The proportion of patients with positive NAb results.
Time frame: Baseline to 30 days after the last dose.
Tmax
Time to reach the maximum blood concentration
Time frame: Baseline to 30 days after the last dose of study treatment
Cmax
Maximum observed 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
QTc interval
Serum concentrations of MRG007, TAb, and unconjugated payload and change in QT interval corrected by Fridericia's formula (ΔQTcF) interval.
Time frame: Baseline to 30 days after the last dose of study treatment