To assess the Safety, Tolerability, and Pharmacokinetic-pharmacodynamic Profile and efficacy of JPI-547 in patients with advanced solid tumor.
This is an open-label, Phase 1 dose escalation and expansion study of NOV140201 (JPI-547) to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and the anti-tumor efficacy of JPI-547 in patients with advanced solid tumors after failure of standard of care. Patients will be enrolled in two stages: a dose-escalation stage and an expansion phase. DLTs will be assessed as the primary endpoint in this trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
62
The dose levels will be escalated following a 3+3 dose escalation scheme.
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Seoul National University College of Medicine
Seoul, South Korea
Dose-limiting toxicity (DLT) and Maximum tolerated dose (MTD)
subjects will be treated and observed for DLT through the end of the first cycle
Time frame: 21days
Area under the plasma concentration versus time curve (AUC) of JPI-547
to observe pharmacokinetic parameter
Time frame: 1 and 15 days
Peak Plasma Concentration (Cmax) of JPI-547
to observe pharmacokinetic parameter
Time frame: 1 and 15 days
Time at maximum concentration(Tmax) of JPI-547
to observe pharmacokinetic parameter
Time frame: 1 and 15 days
Half-life of JPI-547
to observe pharmacokinetic parameter
Time frame: 1 and 15 days
Accumulation ratio of JPI-547
to observe pharmacokinetic parameter
Time frame: 1 and 15 days
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