An Open-Label, Multi-Center, Dose Escalation, Confirmation, and Expansion Phase I Clinical Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of MRG007 (ARR-217) in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors
Summary
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.
Arms & interventions
- DrugMRG007
MRG007 will be administrated as specified in the protocol.
Outcome measures
Primary
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)
Secondary
Objective Response Rate (ORR) - Phase Ia
Time frame: Baseline to study completion (up to 24 months)
Disease Control Rate (DCR)
Time frame: Baseline to study completion (up to 24 months)
Duration of Response (DOR)
Time frame: Baseline to study completion (up to 24 months)
Progression Free Survival (PFS) as assessed by investigator
Time frame: Baseline to study completion (up to 24 months)
Overall Survival (OS)
Time frame: Baseline to study completion (up to 24 months)
Incidence of anti-drug antibody (ADA)
Time frame: Baseline to 30 days after the last dose.
Incidence of neutralizing antibody (NAb)
Time frame: Baseline to 30 days after the last dose.
Tmax
Time frame: Baseline to 30 days after the last dose of study treatment
Cmax
Time frame: Baseline to 30 days after the last dose of study treatment
AUC0-t
Time frame: Baseline to 30 days after the last dose of study treatment
Eligibility criteria
Study locations (10)
ULCA
Los Angeles, California, 90095
UCSF
San Francisco, California, 94158
University of Colorado
Aurora, Colorado, 80010
Sarah Cannon Research Institute
Denver, Colorado, 80218
Sarah Cannon Research Institute
Sarasota, Florida, 34232
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
MD Anderson Cancer Center
Houston, Texas, 77030
NEXT Dallas
Irving, Texas, 75039
NEXT Virginia
Fairfax, Virginia, 22031
Fred Hutchinson Cancer Center
Seattle, Washington, 98109