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

NCT06934590 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-04-23

No results posted yet for this study

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

Interventions

DRUG

RX001

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

Sponsors & Collaborators

  • GeneCraft Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-31
Primary Completion
2026-09-30
Completion
2026-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06934590 on ClinicalTrials.gov