IMP3-saRNA Vaccine in Advanced NSCLC
ConditionNon-Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorWest China Hospital
About this trial
This is an open-label, single-arm, non-randomized, single-center, prospective phase 1 clinical trial. The study will evaluate the safety, tolerability, and preliminary antitumor activity of IMP3-saRNA (YMN-136) vaccine in patients with advanced non-small cell lung cancer.
IMP3-saRNA (YMN-136) is a vaccine product prepared from IMP3 self-amplifying RNA and lipid nanoparticles. The study will enroll patients with histologically or cytologically confirmed non-small cell lung cancer who have failed standard treatment, are intolerant to standard treatment, or have refused standard treatment, and whose tumor tissue is positive for IMP3 expression.
A total of 9 participants are planned to be enrolled. Participants will enter one of three dose groups sequentially: 50 micrograms, 100 micrograms, or 200 micrograms. Each dose group will include 3 participants. The study will use a 3+3 dose-escalation design. The vaccine will be administered by intramuscular injection. The immunization schedule includes 4 doses, with each dose given 3 weeks apart.
The main purpose of the study is to assess safety and tolerability. Dose-limiting toxicity will be assessed from the first vaccination until 14 days after the third vaccination. Safety assessments will include adverse events, serious adverse events, physical examinations, vital signs, ECOG performance status, laboratory tests, 12-lead electrocardiogram, and echocardiography.
The study will also preliminarily assess antitumor activity using RECIST version 1.1. Imaging assessments may include CT or MRI and whole-body bone scan. Additional exploratory evaluations may include blood and tumor tissue biomarker analyses, such as ctDNA, tumor markers, immune cell subsets, dendritic cell maturation, antigen-specific cytotoxic T cells, T-cell activation, antibody titers, PD-L1 expression, gene mutation analysis, and other immune-related tests.
Eligibility criteria
Qualifiers
Patients aged at least 18 years at screening who voluntarily sign an ethics committee-approved informed consent form before any study procedure and agree to participate in this study.
Patients with histologically or cytologically confirmed non-small cell lung cancer who have failed standard treatment, are intolerant to standard treatment, or have refused standard treatment, and whose tumor tissue is positive for IMP3 expression. The IMP3 pathological test result must be issued by the pathology department of this hospital or by a qualified pathology institution recognized by the study center. If a previous pathology report cannot confirm IMP3 status, IMP3 testing must be performed during screening, and only patients with positive results may be enrolled.
Patients with EGFR-sensitive mutations must have failed third-line or later treatment, including failure of at least one EGFR-TKI.
Patients with ALK-positive disease must have failed third-line or later treatment, including failure of at least one ALK inhibitor.
Disqualifiers
Patients with a history of other malignancies, except for malignancies considered eligible by the investigator, such as cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, or intramucosal gastrointestinal carcinoma without recurrence within 5 years before screening.
Any uncontrolled clinical disease, such as respiratory, circulatory, digestive, neurologic, hematologic, genitourinary, or endocrine disease, or psychiatric disease, such as depression or schizophrenia, or other major disease that, in the investigator's judgment, may interfere with provision of informed consent, interfere with interpretation of study results, pose a risk to the participant by participating in this study, or otherwise affect achievement of the study objectives.
Any active autoimmune disease or history of autoimmune disease, including but not limited to immune-related neurologic disease, multiple sclerosis, autoimmune demyelinating neuropathy, Guillain-Barre syndrome, myasthenia gravis, systemic lupus erythematosus, connective tissue disease, scleroderma, inflammatory bowel disease including Crohn's disease and ulcerative colitis, autoimmune hepatitis, toxic epidermal necrolysis, or Stevens-Johnson syndrome, except type 1 diabetes mellitus controlled with a stable dose of insulin. Participants with vitiligo or childhood asthma that has completely resolved and requires no intervention in adulthood may be enrolled; participants with asthma requiring medical intervention with bronchodilators are not eligible.
Patients with active central nervous system metastases, including but not limited to carcinomatous meningitis and spinal cord compression, must be excluded. However, patients with metastatic central nervous system tumors may participate in this study if they have recovered to baseline for at least 2 weeks before enrollment, with no residual signs or symptoms related to central nervous system treatment. In addition, patients must have discontinued corticosteroids for 4 weeks.
Trial design
Treatments tested in this trial
- IMP3-saRNA (YMN-136) Vaccine
Treatment groups
9 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov