Voronoi, a biotech company developing a novel drug pipeline for non-small cell lung cancer (NSCLC), announced on Thursday that it has received approval for modifications to the clinical trial plan for its drug candidate VRN110755.
The Phase 1/2 clinical trial aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of VRN110755 in patients with Epidermal Growth Factor Receptor (EGFR) mutation-positive Non-Small Cell Lung Cancer (NSCLC).
The Taiwan Food and Drug Administration (TFDA) has approved these modifications, and the trial is set to take place across North America, Asia, Oceania, and Europe.
This global, multi-center study will enroll approximately 391 patients. The trial is structured in two parts: a dose escalation phase and a dose expansion phase, with long-term follow-up extending up to six years.
The application for these changes was submitted on February 6, 2026, and received approval on Wednesday.
A spokesperson for Voronoi explained the rationale behind the modification request: Following the confirmation of the drug’s safety and tolerability in the Phase 1a trial, along with promising early efficacy signals, it is expanding to a Phase 1b/2 trial. This expansion will allow us to determine the optimal dosage and further assess efficacy in our target patient population.