A Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of VRN110755 in Patients with Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer (NSCLC)

Condition studied

EGFR-mutant Non–Small Cell Lung Cancer (NSCLC)

Investigational medicinal product(s)

Eligibility

Primary endpoint

Phase 1a, 1b: incidence of incidence of dose-limiting toxicity ( DLTs) (Phase 1a Cycle 1 only), incidence of adverse events (AEs)/serious AEs (SAEs), vital signs, laboratory tests, physical/ophthalmic examinations, electrocardiogram, ECOG performance status., Phase 2: efficacy endpoints including : objective response rate( ORR),Duration of Response(DOR), Disease Control Rate(DCR), Progression-free survival (PFS),Overall survival (OS), and intracranial ORR and PFS if brain metastatic lesions are present ; incidence of AEs/SAEs ; vital signs, laboratory tests, physical/ophthalmic examinations, electrocardiogram, and ECOG performance status., Phase 2: Change from baseline in ctDNA levels by a lab testing method at screening, C2D1, C3D1, and EOT

Endpoint detail

Phase 1a & 1b: PK parameters of VRN110755; change from baseline in ctDNA levels by lab testing at screening, C2D1 and EOT and in phase 1b also each subsequent treatment cycle; efficacy endpoints including confirmed ORR,DOR,DCR, PFS, and intracranial ORR and PFS if brain metastatic lesions are present. Phase 2: PK parameters of VRN110755.