The purpose of this study is to evaluate the safety and tolerability, and determine the maximum tolerated dose of INCB062079 in subjects with advanced hepatocellular carcinoma and other malignancies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
In Part 1, initial cohort dose of INCB062079 at the protocol-defined starting dose, with subsequent dose escalations based on protocol-specific criteria. The recommended dose(s) from Part 1 will be taken forward into Part 2 cohorts.
University of Alabama
Birmingham, Alabama, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Toledo Medical Center
Toledo, Ohio, United States
Institut Jules Bordet
Brussels, Belgium
Safety and tolerability of INCB062079 as measured by assessment of adverse events (AEs)
An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a subject provides informed consent.
Time frame: Baseline to 30-35 days after end of treatment, up to approximately 6 months per subject.
Objective Response Rate
Defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per modified Response Evaluation Criteria (RECIST) in hepatocellular carcinoma (HCC) and standard Response Evaluation Criteria (RECIST v1.1) in participants with other advanced malignancies.
Time frame: Every 2 cycles during the treatment period and every 8 weeks during the follow-up period, up to approximately 6 months per subject.
Cmax of INCB062079
Defined as maximum observed plasma concentration.
Time frame: Protocol-defined time points during Cycles 1 and 2 of treatment, up to approximately 2 months per subject.
Tmax of INCB062079
Defined as time to maximum plasma concentration.
Time frame: Protocol-defined time points during Cycles 1 and 2 of treatment, up to approximately 2 months per subject.
Cmin of INCB062079
Defined as minimum observed plasma concentration during the dosing interval.
Time frame: Protocol-defined time points during Cycles 1 and 2 of treatment, up to approximately 2 months per subject.
AUC0-t of INCB062079
Defined as area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cliniques Universitaires Saint-Luc
Brussels, Belgium
University Hospital (UZ) Leuven
Leuven, Belgium
Time frame: Protocol-defined time points during Cycles 1 and 2 of treatment, up to approximately 2 months per subject.
t½ of INCB062079
Defined as the apparent plasma terminal phase disposition half-life.
Time frame: Protocol-defined time points during Cycles 1 and 2 of treatment, up to approximately 2 months per subject.
Cl/F of INCB062079
Defined as oral dose clearance.
Time frame: Protocol-defined time points during Cycles 1 and 2 of treatment, up to approximately 2 months per subject.
Analysis of biomarkers
A plasma sample will be collected during screening for possible analysis of FGFR4 pathway mutations using tumor circulating DNA.
Time frame: Screening visit