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Evaluate Safety and Tolerability of RX001 in Patients With KRAS Mutant Advanced NSCLC
Sponsor: GeneCraft Inc.
Summary
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.
Official title: An Open-label, Dose Escalation, Phase I Study to Evaluate Safety and Tolerability of RX001 in Patients With KRAS Mutant Advanced Non-small Cell Lung Cancer
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
18
Start Date
2025-05
Completion Date
2026-12
Last Updated
2025-04-23
Healthy Volunteers
No
Conditions
Interventions
RX001
Subjects will receive a single RX001 (AAV-hRUNX3) treatment via Intra-tumoral injection
Locations (1)
Konkuk University Medical Center
Seoul, South Korea