A Study of VRN110755 in Patients With EGFR-Mutant Non-Small Cell Lung Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
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.
Eligibility
Primary outcome measure(s)
- Estimate of Maximum Tolerated Dose (MTD) of VRN110755 — 28 days
This will be based on dose-limiting toxicities (DLTs) observed during the DLT evaluation period. - Number of participants with dose-limiting toxicities (DLTs) following treatment with VRN110755 — 28 days
Dose-limiting toxicities will be assessed according to protocol-defined DLT criteria during the DLT evaluation period. - Number of participants experiencing treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events leading to discontinuation — From first dose until end of study (up to approximately 6 years)
- Number of participants with changes in vital signs from baseline following treatment with VRN110755 — From baseline through End of Treatment (up to approximately 6 years)
Vital signs include blood pressure, pulse rate, respiratory rate, body temperature, and oxygen saturation. - Number of participants with changes in laboratory test results from baseline following treatment with VRN110755 — From baseline through End of Treatment (up to approximately 6 years)
Laboratory evaluations include hematology, clinical chemistry, coagulation, and urinalysis assessments. - Number of participants with changes in physical examination findings from baseline following treatment with VRN110755 — From baseline through End of Treatment (up to approximately 6 years)
Physical examinations include complete physical examinations at screening and End of Treatment and symptom-directed physical examinations during study treatment. - Number of participants with changes in ophthalmologic examination findings from baseline following treatment with VRN110755 — From baseline through End of Treatment (up to approximately 6 years)
Ophthalmologic examinations include best corrected visual acuity, intraocular pressure, slit-lamp examination, spectral-domain optical coherence tomography (SD-OCT), confrontation visual fields, and fundoscopic examination. - Number of participants with changes in electrocardiogram (ECG) parameters from baseline following treatment with VRN110755 — From baseline through End of Treatment (up to approximately 6 years)
Electrocardiogram assessments include 12-lead ECG parameters, including QT interval corrected using Fridericia's formula (QTcF). - Number of participants with changes in Eastern Cooperative Oncology Group (ECOG) Performance Status from baseline following treatment with VRN110755 — From baseline through End of Treatment (up to approximately 6 years)
Trial sites (29)
| Facility | City | Region | Status |
|---|---|---|---|
| Southern Oncology Clinical Research Unit | Bedford Park | South Australia | Recruiting |
| Monash Medical Centre Clayton | Clayton | Victoria | Recruiting |
| Princess Margaret Cancer Centre | Toronto | Ontario | Recruiting |
| AP-HM Hôpital Nord | Marseille | Bouches-du-Rhône | Recruiting |
| Centre Georges François Leclerc | Dijon | Côte-d'Or | Recruiting |
| Prince of Wales Hospital | Hong Kong | Hong Kong | Recruiting |
| Queen Mary Hospital | Hong Kong | Hong Kong | Recruiting |
| Hospital Umum Sarawak | Kuching | Sarawak | Recruiting |
| Hospital Kuala Lumpur | Kuala Lumpur | Malaysia | Recruiting |
| University Malaya Medical Centre | Kuala Lumpur | Malaysia | Recruiting |
| Institut Kanser Negara | Putrajaya | Malaysia | Recruiting |
| National Cancer Centre Singapore | Singapore | Singapore | Recruiting |
| Tan Tock Seng Hospital | Singapore | Singapore | Recruiting |
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | Recruiting |
| The Catholic University of Korea, St. Vincent's Hospital | Suwon | Gyeonggi-do | Recruiting |
| Chungbuk National University Hospital | Cheongju-si | North Chungcheong | Recruiting |
| Severance Hospital Yonsei University Health System | Seoul | South Korea | Recruiting |
| Samsung Medical Center | Seoul | South Korea | Recruiting |
| ICO Badalona - Hospital Universitari Germans Trias i Pujol | Badalona | Barcelona | Recruiting |
| ICO l'Hospitalet - Hospital Duran i Reynals | L'Hospitalet de Llobregat | Barcelona | Recruiting |
| Hospital Universitario 12 de Octubre | Madrid | Spain | Recruiting |
| Hospital Regional Universitario de Málaga - Hospital Civil | Málaga | Spain | Recruiting |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | Taiwan | Recruiting |
| Taichung Veterans General Hospital | Taichung | Taiwan | Recruiting |
| National Taiwan University Hospital | Taipei | Taiwan | Recruiting |
| Taipei Medical University Hospital | Taipei | Taiwan | Recruiting |
| Taipei Veterans General Hospital | Taipei | Taiwan | Recruiting |
| Phramongkutklao Hospital | Thung Phaya Thai | Bangkok Metropolis | Recruiting |
| Songklanagarind Hospital Prince of Songkla University | Hat Yai | Changwat Songkhla | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07699328 on ClinicalTrials.gov ↗ ← All trials in Canada