Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07699328
PHASE1/PHASE2

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

Sponsor: Voronoi, Inc

View on ClinicalTrials.gov

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

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.

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