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

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 antitum

Trial Details

NCT ID
NCT07699328
Phase
PHASE1 / PHASE2
Sponsor
Voronoi, Inc
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • VRN110755
Locations (sample)
  • Bedford Park, South Australia, Australia|-35.02204,138.56815
  • Clayton, Victoria, Australia|-37.91667,145.11667
  • Toronto, Ontario, Canada|43.70643,-79.39864
  • Marseille, Bouches-du-Rhône, France|43.29695,5.38107
  • Dijon, Côte-d'Or, France|47.31344,5.01391

Key Eligibility Criteria

  • Adults aged 18 years or older (19 years or older in the Republic of Korea).
  • Able to understand, sign, and provide written informed consent.
  • Histologically or cytologically confirmed advanced, metastatic, or recurrent predominantly nonsquamous non-small cell lung cancer (NSCLC) with a do…
  • At least one measurable extracranial lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.

For full eligibility, visit ClinicalTrials.gov.

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