LNP3794
DrugLNP3794 capsules administered orally once daily
NCT Number: NCT05187858
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Cliniques universitaires Saint-Luc, Brussels, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
LNP3794 capsules administered orally once daily
Time frame: up to Day 28
Dose limiting toxicities will be evaluated through the first cycle (each cycle is 28 days)
Time frame: up to 2 years
Dose limiting toxicities will be evaluated through the entire on-treatment period
Time frame: up to 2 years
Grade ≥3 treatment-related adverse events will be evaluated through the entire on-treatment period
Time frame: up to 2 years
Treatment-related AEs at each dose level will be evaluated through the entire on-treatment period
Time frame: Cycle 1 (each cycle is 28 days) Day 1 and Day 14
Cmax is the maximum observed plasma concentration.
Time frame: Cycle 1 (each cycle is 28 days) Day 1 and Day 14
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 to 2 and Day 14 to 15
AUC[0-tau] is the measure of plasma drug concentration from time zero to the end of dosing interval.
Time frame: Cycle 1 (each cycle is 28 days) Day 1 and Day 14
Tmax is the time to reach maximum plasma concentration.
Time frame: Baseline and Cycle 1 (each cycle is 28 days) Day 14
Change from baseline in pERK levels will be evaluated
Time frame: up to 2 years
Objective response rate (ORR) and disease control rate (DCR) will be determined using response evaluation criteria in solid tumors (RECIST) v1.1.
Lupin Ltd.
Industry
A Phase I Open-Label Study of LNP3794 (BI3011441) in Subjects With NRAS/KRAS Mutated Advanced or Metastatic Refractory Solid Tumors
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.