IMP3-saRNA Vaccine in Advanced NSCLC

NCT07561723 | Not Yet Recruiting Phase 1

• 1 other identifier: 2026-864
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

Brief Summary

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, are intolerant to, or refuse 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 in sequence: 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 given by intramuscular injection. The basic 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 observed 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 v1.1 criteria. 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.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  The ratio of participants assessed with complete response (CR) or partial response(PR) as a best overall response.

  1 years

Secondary Outcomes (7)

• PFS (progression-free survival)

  1 years

• OS (Overall Survival)

  1 years

• Disease Control Rate (DCR)

  1 years

• TTR (Response Time）

  1 years

• TTP (Time to Progression)

  1 years

Study Arms (1)

IMP3-saRNA (YMN-136) Vaccine

EXPERIMENTAL

Biological: IMP3-saRNA (YMN-136) Vaccine

Interventions

IMP3-saRNA (YMN-136) Vaccine BIOLOGICAL

IMP3-saRNA (YMN-136) vaccine is a biological vaccine product prepared from IMP3 self-amplifying RNA and lipid nanoparticles. The vaccine will be administered by intramuscular injection. Participants will be enrolled sequentially into dose groups of 50 micrograms, 100 micrograms, and 200 micrograms using a 3+3 dose-escalation design. The basic immunization schedule includes 4 doses, with each dose given 3 weeks apart. Dose-limiting toxicity will be assessed from the first vaccination until 14 days after the third vaccination.

IMP3-saRNA (YMN-136) Vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged \>18 years at screening, including the boundary value, 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 refuse 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.
• Note:
• 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.
• Patients with ROS1-positive disease must have failed third-line or later treatment, including failure of at least one ROS1 inhibitor.
• Patients with EGFR wild-type disease and no ALK or ROS1 positivity must have failed second-line or later treatment, including platinum-containing treatment.
• At least one measurable or evaluable lesion according to RECIST version 1.1.
• Eastern Cooperative Oncology Group performance status score of 0 to 2.
• Estimated life expectancy of at least 3 months.
• Adequate major organ function, with the following test results meeting the requirements within 7 days before treatment:
• Hemoglobin ≥80 g/L without blood transfusion within 14 days; absolute neutrophil count \>1.5 × 10\^9/L; white blood cell count ≥3.0 × 10\^9/L; platelet count ≥80 × 10\^9/L.
• Total bilirubin ≤1.5 × upper limit of normal; alanine aminotransferase or aspartate aminotransferase ≤2.5 × upper limit of normal; in patients with liver metastasis, alanine aminotransferase or aspartate aminotransferase ≤5 × upper limit of normal.
• Serum creatinine ≤1.5 × upper limit of normal or creatinine clearance estimated by the Cockcroft-Gault formula ≥60 mL/min.
• Prothrombin time and international normalized ratio ≤1.5 × upper limit of normal, unless the patient is receiving warfarin anticoagulation.

You may not qualify if:

• 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.
• Allergy to the study drug, including any excipients. History of severe allergy to any drug, food, or vaccination, such as anaphylactic shock, allergic laryngeal edema, allergic dyspnea, allergic purpura, thrombocytopenic purpura, or local allergic necrotic reaction, such as Arthus reaction.
• Contraindications to injection: a. inflammation, trauma, or ulceration at the injection site; b. severe bleeding or coagulation tendency, or marked decrease in platelets or coagulation factors; c. any abnormality or permanent body art, such as a tattoo, at the vaccination site that, in the investigator's judgment, may interfere with observation of local reactions at the vaccination site.
• Prior organ transplantation or allogeneic hematopoietic stem cell transplantation.
• Prior antitumor therapeutic vaccine or cellular immunotherapy.
• Participation in another drug or device clinical trial within 4 weeks before screening.
• Major surgery within 4 weeks before the first vaccination, except for minor procedures such as catheter placement or protocol-required biopsy, or insufficient resolution of the effects of surgery or trauma for at least 14 days before enrollment.
• Participants who have received systemic treatment with corticosteroids at a dose \>10 mg/day prednisone or an equivalent dose of another glucocorticoid, or other immunosuppressive agents, within 14 days before the first vaccination. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal hormone replacement therapy at a dose ≤10 mg/day prednisone equivalent are allowed.
• Before the first administration of the study drug, any toxicity caused by previous antitumor therapy has not recovered to NCI CTCAE version 5.0 grade ≤1, except for alopecia of any grade and grade 2 neuropathy related to prior platinum therapy.
• Known hepatitis B virus, hepatitis C virus, human immunodeficiency virus, or syphilis infection, or positive screening test for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C virus antibody, HIV antibody, or Treponema pallidum antibody: HBsAg positivity or HBcAb positivity with HBV DNA quantitative test result ≥500 IU/mL or 2000 copies/mL, or the lower limit of positivity at the study center; HCVAb positivity with HCV RNA ≥ the upper limit of normal at the study center.
• History of drug abuse or known medical, psychological, or social conditions, such as alcoholism or drug addiction.
• Pregnant or breastfeeding women, or female participants planning pregnancy or male participants whose partners plan pregnancy from screening until 12 months after completion of all study drug injections.

Sponsors & Collaborators

• West China Hospital: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Central Study Contacts

Xingchen Peng, Professor

CONTACT

18980606753; pxx2014@163.com

Ziyu Xu

CONTACT

19961578835@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Professor

Study Record Dates

• First Submitted: April 25, 2026
• First Posted: May 1, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2029
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share