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A Study of VRN110755 in Patients With EGFR-Mutant Non-Small Cell Lung Cancer
Sponsor: Voronoi, Inc
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
315
Start Date
2024-03-26
Completion Date
2029-01-01
Last Updated
2026-07-13
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (29)
Southern Oncology Clinical Research Unit
Bedford Park, South Australia, Australia
Monash Medical Centre Clayton
Clayton, Victoria, Australia
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
AP-HM Hôpital Nord
Marseille, Bouches-du-Rhône, France
Centre Georges François Leclerc
Dijon, Côte-d'Or, France
Prince of Wales Hospital
Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Hospital Umum Sarawak
Kuching, Sarawak, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, Malaysia
University Malaya Medical Centre
Kuala Lumpur, Malaysia
Institut Kanser Negara
Putrajaya, Malaysia
National Cancer Centre Singapore
Singapore, Singapore
Tan Tock Seng Hospital
Singapore, Singapore
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, South Korea
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, South Korea
Severance Hospital Yonsei University Health System
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
ICO Badalona - Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
ICO l'Hospitalet - Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Regional Universitario de Málaga - Hospital Civil
Málaga, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Medical University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Phramongkutklao Hospital
Thung Phaya Thai, Bangkok Metropolis, Thailand
Songklanagarind Hospital Prince of Songkla University
Hat Yai, Changwat Songkhla, Thailand