Evaluate Safety and Tolerability of RX001 in Patients With KRAS Mutant Advanced NSCLC

This is an open-label, dose-escalation Phase I study to evaluate the safety and tolerability of RX001 monotherapy in patients with advanced KRAS mutant NSCLC. Subjects aged ≥19 years with advanced NSCLC with KRAS mutations will be enrolled. Based on the investigator's judgment of the lung tumor location, RX001 will be administered as a single intratumoral treatment via bronchoscopy or CT-guided percutaneous injection. Additionally, after conducting safety, tolerability, and preliminary anti-tumor efficacy assessments for all subjects up to Week 12 (D84) following IP administration, the collected data will be reviewed by the SRC for a comprehensive evaluation. If the IP is designated for long-term follow-up studies, monitoring for malignant tumor formation and other SAEs specified by the Ministry of Food and Drug Safety (MFDS) will be conducted for a minimum of 5 years.

NCT Number	NCT06934590
Lead Sponsor	GeneCraft Inc.
Conditions	Non-Small Cell Lung Cancer
Enrollment	18 participants
Start Date	2025-05
Primary Completion	2026-09 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2025-04-23