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Non-Small Cell Lung CancerPhase 1NCT06934590

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

A Phase 1 study testing RX001 in people with Non-Small Cell Lung Cancer, run by GeneCraft Inc. at 1 site in South Korea.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
RX001
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteSouth Korea
Study dates
May 2025to Dec 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults aged ≥19 years, male or female
  • Subject with histologically and/or cytologically confirmed, unresectable advanced NSCLC for radical cure that are confirmed as PD for the standard of care currently known to have clinical benefits, or for which no currently available standard of care exists due to intolerance, ineligibility, treatment refusal, etc.
  • Subjects must have at least one evaluable and injectable lesion as assessed on CT images based on RECIST version 1.1.
  • Subjects with valid biopsy results documented the presence of KRAS mutation.
  • Subjects with an ECOG performance status of 0 or 1 and an expected survival of at least 12 weeks at the time of study participation.
  • Subjects with adequate hematologic and terminal organ function.
  • Subjects must voluntarily sign an informed consent form approved by the IRB. Subjects must have the willingness and ability to comply with all procedures required by the protocol.

Who cannot join

  • Subjects must not meet any of the following conditions:
  • Subjects with a history of or current comorbidities including:
  • Hematologic malignancies, such as lymphoma, or any other malignant tumors apart from the indication of this study.
  • Subjects with the cardiovascular conditions such as unstable angina and/or myocardial infarction within 1 year prior to screening
  • Subjects with the pulmonary baseline conditions:
  • Blood coagulation disorder
Show all 16Show fewer
  • Active bleeding disorders (including gastrointestinal bleeding)
  • Subjects who have received antithrombotics, including antiplatelets or anticoagulants
  • Subjects who have received anticancer therapies within 28 days prior to trial participation, or who have not recovered or stabilized from all AEs caused by such treatments to baseline levels
  • Subjects who have received radical radiotherapy within 6 weeks prior to trial participation etc.
  • Subjects who have received live vaccines or attenuated vaccines within 4 weeks prior to study participation
  • Subjects with active HBV or HCV, or HIV positive
  • Subjects with severe infections requiring antibiotics, antifungal agents, or antiviral agents, or those with uncontrolled active infectious diseases
  • Subjects with any form of primary immunodeficiency or active autoimmune diseases
  • Subjects who have previously received intratumoral therapy for the target lesion
  • Ineligibility or inability to participate in the study at the investigator's discretion

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kyoungmi Jung, PhD, Seoul contact

82 2-400-8890

kmjung@genecraft.co.kr

South Korea1 site

  • Konkuk University Medical Center

    Seoul, 05030

    Lee, Professor, 82 02 2030-7521, kyleemd@kuh.ac.kr

Other trials in South Korea

About this study

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

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.

Being tested
RX001
Keywords
KRAS, NSCLC, RUNX3, AAV
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RX001Drug

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

Study groups in NCT06934590
Study groupRoleWhat they receive
RX001ExperimentalRX001
Receives: Drug: RX001

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of treatment-related serious adverse event (SAE) rate

    Incidence of SAEs throughout the study

    SAE: an adverse event or suspected adverse reaction is considered "serious" if, in the view of the investigator, it results in any of the following outcomes:

    Death or a life-threatening adverse event Inpatient hospitalization or prolongation of existing hospitalization A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions A congenital anomaly/birth defect Any other important medical event that does not fit the criteria above but, based upon appropriate medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed above

    Measured: Observation for 12 weeks following a single dose

Secondary outcomes (3)

  1. Objective response rate (ORR)

    • ORR = percentage of participants with complete response + partial response.
    • Complete response (CR): Disappearance of all target lesions.
    • Partial response (PR): At least a 30% decrease in the diameters of target lesions, taking as reference the baseline diameters.

    Measured: Observation for 12 weeks following a single dose

  2. Progression-free survival (PFS)

    PFS is defined as the time from date of treatment initiation to disease progression or death from any cause, whichever occurs first.

    Measured: Observation for 12 weeks following a single dose

  3. Target Tumor Size

    Changes in the maximum length of the target lesion

    Measured: Observation for 12 weeks following a single dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2025
  2. Study startMay 2025 (estimated)
  3. Primary completionSep 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06934590
Sponsor's protocol ID
GC-LCP1001
Status last verified
Apr 2025
First submitted
2 Apr 2025
Last updated
23 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The current position is "No" due to pending internal policy decisions. However, revision of internal regulations is under review to allow for potential future data sharing and registry compliance.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RX001 in people with Non-Small Cell Lung Cancer, run by GeneCraft Inc. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kyoungmi Jung, PhD, Seoul (82 2-400-8890, kmjung@genecraft.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-related serious adverse event (SAE) rate (time frame: Observation for 12 weeks following a single dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06934590.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.

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