This is a Phase I, open-label, dose escalation study of LNP3794 (BI3011441) in subjects with NRAS/KRAS mutated advanced or metastatic refractory solid tumors. The purpose of this study is to evaluate the safety/tolerability, pharmacokinetic and pharmacodynamic profile of the orally administered LNP3794 (BI3011441) as monotherapy at selected dose levels.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
LNP3794 capsules administered orally once daily
Cliniques universitaires Saint-Luc
Brussels, Belgium
Amsterdam UMC
Amsterdam, Netherlands
Sarah Cannon Research Institute
London, United Kingdom
The Christie NHS Foundation
Manchester, United Kingdom
Number of subjects with dose limiting toxicities (DLTs) at each dose level during the first cycle
Dose limiting toxicities will be evaluated through the first cycle (each cycle is 28 days)
Time frame: up to Day 28
Number of subjects with DLTs during the entire on-treatment period
Dose limiting toxicities will be evaluated through the entire on-treatment period
Time frame: up to 2 years
Number of subjects with Grade ≥3 treatment-related adverse events (AEs)
Grade ≥3 treatment-related adverse events will be evaluated through the entire on-treatment period
Time frame: up to 2 years
Number of subjects with treatment-related AEs at each dose level
Treatment-related AEs at each dose level will be evaluated through the entire on-treatment period
Time frame: up to 2 years
Maximum Plasma Concentration (Cmax) of LNP3794
Cmax is the maximum observed plasma concentration.
Time frame: Cycle 1 (each cycle is 28 days) Day 1 and Day 14
Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC[0-last])
AUC\[0-last\] is the measure of plasma drug concentration from time zero to the time of last quantifiable concentration.
Time frame: Cycle 1 (each cycle is 28 days) Day 1 and Day 14
Area under the concentration-time curve from time zero to the end of dosing interval (AUC[0-tau])
AUC\[0-tau\] is the measure of plasma drug concentration from time zero to the end of dosing interval.
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Time frame: Cycle 1 (each cycle is 28 days) Day 1 to 2 and Day 14 to 15
Time to maximum concentration (Tmax)
Tmax is the time to reach maximum plasma concentration.
Time frame: Cycle 1 (each cycle is 28 days) Day 1 and Day 14