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
Overview
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- GeneCraft Inc.
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Incidence of treatment-related serious adverse event (SAE) rate
Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •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 Criteria
- •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.
Arms & Interventions
RX001
RX001
Intervention: RX001 (Drug)
Outcomes
Primary Outcomes
Incidence of treatment-related serious adverse event (SAE) rate
Time Frame: Observation for 12 weeks following a single dose
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
Secondary Outcomes
- Objective response rate (ORR)(Observation for 12 weeks following a single dose)
- Progression-free survival (PFS)(Observation for 12 weeks following a single dose)
- Target Tumor Size(Observation for 12 weeks following a single dose)