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A Study of VRN110755 in Patients With EGFR-Mutant Non-Small Cell Lung Cancer

NCT07699328 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 315

Last updated 2026-07-13

No results posted yet for this study

Summary

This first-in-human, Phase 1/2, multicenter, open-label, non-randomized study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of VRN110755, a highly selective oral epidermal growth factor receptor (EGFR) inhibitor, in patients with EGFR-mutant non-small cell lung cancer (NSCLC).

The study includes a Phase 1a dose-escalation portion, a Phase 1b dose-expansion portion, and a Phase 2 evaluation. The study is designed to determine the maximum tolerated dose and recommended Phase 2 dose of VRN110755 and to evaluate preliminary and confirmatory antitumor activity in patients with EGFR-mutant NSCLC, including patients with acquired resistance following EGFR tyrosine kinase inhibitor therapy.

Conditions

  • EGFR-Mutant Non-Small Cell Lung Cancer

Interventions

DRUG

VRN110755

VRN110755 is an investigational highly selective oral EGFR inhibitor supplied as capsules for oral administration. The drug is designed to target activating EGFR mutations and selected resistance mutations, including C797S, in patients with EGFR-mutant NSCLC.

Sponsors & Collaborators

  • Voronoi, Inc

    lead INDUSTRY

Principal Investigators

  • Hongryul Jung, PhD · Voronoi, Inc

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-26
Primary Completion
2029-01-01
Completion
2029-01-01

Countries

  • Australia
  • Canada
  • France
  • Hong Kong
  • Malaysia
  • Singapore
  • South Korea
  • Spain
  • Taiwan
  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07699328 on ClinicalTrials.gov