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NOT YET RECRUITING
NCT06934590
PHASE1

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

Sponsor: GeneCraft Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

RX001

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

Locations (1)

Konkuk University Medical Center

Seoul, South Korea