NCT06934590

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: GeneCraft Inc. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	RX001	Subjects will receive a single RX001 (AAV-hRUNX3) treatment via Intra-tumoral injection

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-09-01
• Completion: 2026-12-01
• First posted: 2025-04-18
• Last updated: 2025-04-23

Locations

1 site across 1 country: South Korea