The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of INCB086550 in participants with advanced solid tumors who have failed prior treatments.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
138
INCB086550 will be orally administered once or twice daily in continuous or intermittent dose schedules.
Georgetown University Hospital
Washington D.C., District of Columbia, United States
Number of treatment-emergent adverse events
Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Time frame: Baseline through 90 days after end of treatment, estimated up to 12 months.
Cmax of INCB086550 in fasted and food effect conditions
Maximum observed plasma or serum concentration.
Time frame: Approximately 1 month
tmax of INCB086550 in fasted and food effect conditions
Time to maximum concentration.
Time frame: Approximately 1 month
AUC0-tau of INCB086550 in fasted and food effect conditions
Area under the plasma or serum concentration-time curve from time = 0 to the end of dosing period at steady state
Time frame: Approximately 1 month
AUC 0-t and/or AUC0-∞ of INCB086550 in fasted and food effect conditions
Area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration, or Area under the single-dose plasma concentration-time curve from Hour 0 to infinity
Time frame: Approximately 1 month
t½ of INCB086550
Apparent terminal-phase disposition half-life.
Time frame: Approximately 1 month
λz of INCB086550
Apparent terminal-phase disposition rate constant
Time frame: Approximately 1 month
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H. Lee Moffitt Cancer Center and Research Institute Hospital
Tampa, Florida, United States
Aamc Oncology and Hematology
Annapolis, Maryland, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
Jefferson University Hospitals
Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Md Anderson Cancer Center
Houston, Texas, United States
Institut Jules Bordet
Brussels, Belgium
Universitair Ziekenhuis Antwerpen (Uza)
Edegem, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
...and 15 more locations
CL/F of INCB086550
Apparent oral dose clearance.
Time frame: Approximately 1 month
Vz/F of INCB086550
Apparent oral dose volume of distribution.
Time frame: Approximately 1 month
Pharmacokinetic/pharmacodynamics correlation
Evaluation of the ability of INCB086550 to modulate PD-L1 expression levels as assessed by flow cytometry protein analyses.
Time frame: Approximately 1 month
Objective response rate
Defined as the percentage of participants having complete response (CR) or partial response (PR) by investigator assessment of radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or response assessment in Neuro-Oncology (RANO).
Time frame: Every 8 weeks for the duration of study participation; estimated to be 12 months.
Disease control rate
Defined as the percentage of participants having CR, PR, or stable disease ≥ 12 weeks by investigator assessment of radiographic disease assessments per RECIST v1.1 or response assessment in Neuro-Oncology (RANO).
Time frame: Every 8 weeks for the duration of study participation; estimated to be 12 months.
Duration of response
Defined as the time from the first documented evidence of CR or PR until the earliest date of disease progression by investigator assessment per RECIST v1.1 for response assessment in Neuro-Oncology (RANO), or death due to any cause, if occurring sooner than progression.
Time frame: Every 8 weeks for the duration of study participation; estimated to be 12 months.
Cmin of INCB086550 in fasted and food effect conditions
Minimum observed plasma or serum concentration of INCB086550
Time frame: Approximately 1 month