This Phase 1 study is designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of AMV564 alone and in combination with Pembrolizumab in patients with advanced solid tumors.
AMV564-301 is a Phase 1, open-label, multicenter dose-escalation with expansion trial in patients with locally advanced or metastatic solid tumors. In the dose-escalation portion of the study, cohorts of patients will receive AMV564 alone or in combination with Pembrolizumab at increasing dose levels to determine the maximum tolerated dose (MTD) and/or the recommended dose for expansion. In the expansion portion of the study, one or more cohorts of patients will receive AMV564 at the MTD or recommended dose to further evaluate safety, tolerability, and clinical activity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
65
AMV564 will be administered daily
UCLA
Los Angeles, California, United States
Advent Health
Orlando, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Incidence of Treatment-Related Adverse Events
As measured by the incidence, nature and severity of adverse events (AEs) and serious AEs
Time frame: Through study completion, an average of 19 months
Maximum tolerated dose of AMV564 in subjects with advanced solid tumors
As determined based on the occurrence of dose-limiting toxicity
Time frame: During Dose Escalation, an average of 6 months
Preliminary evaluation of AMV564 efficacy in subjects enrolled in the expansion phase
As measured by the objective response rate (ORR)
Time frame: During Dose Expansion, an average of 1 year
Maximum observed drug concentration (Cmax) of AMV564
Measured by plasma concentration
Time frame: Through study completion, an average of 19 months
Concentration at steady state (Css) of AMV564
Measured by plasma concentration
Time frame: Through study completion, an average of 19 months
Time of the maximum drug concentration (Tmax) of AMV564
Measured by plasma concentration
Time frame: Through study completion, an average of 19 months
Apparent terminal half-life (t½) of AMV564
Measured by plasma concentration
Time frame: Through study completion, an average of 19 months
Area under the concentration-time curve (AUC) of AMV564
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Northwestern University
Chicago, Illinois, United States
Duke University Medical Center
Durham, North Carolina, United States
The Christ Hospital
Cincinnati, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
MD Anderson Cancer Center
Houston, Texas, United States
NEXT Oncology
San Antonio, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
...and 1 more locations
Measured by plasma concentration
Time frame: Through study completion, an average of 19 months