Status:
NOT_YET_RECRUITING
Evaluate Safety and Tolerability of RX001 in Patients With KRAS Mutant Advanced NSCLC
Lead Sponsor:
GeneCraft Inc.
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
19+ years
Phase:
PHASE1
Brief 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 NSC...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06934590
Start Date
May 1 2025
End Date
December 1 2026
Last Update
April 23 2025
Active Locations (1)
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1
Konkuk University Medical Center
Seoul, South Korea, 05030