Application of KRAS Vaccine in the Treatment of KRAS-mutated Malignancies

Launched by SICHUAN UNIVERSITY · May 26, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new type of treatment called an mRNA vaccine specifically designed for patients with certain advanced cancers that have a KRAS mutation. The main goal of the study is to see if this vaccine is safe and effective for treating these kinds of tumors. The trial is not yet recruiting participants, but when it does, it will be open to adults 18 years and older who have solid tumors with confirmed KRAS mutations and have not responded to previous standard treatments.

To be eligible for the trial, participants must have measurable cancer lesions and a good physical condition score, indicating they can handle the treatment. Participants should also expect to undergo tests to confirm their eligibility and will need to provide written consent to join the study. It's important to note that certain conditions, like active infections, other cancers, or serious heart issues, may prevent someone from joining. Overall, this trial aims to explore a promising new treatment option for patients with specific advanced cancers.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • Male or female participants ≥18 years of age.
• • Participants with solid tumors confirmed to carry KRAS mutations.
• • At least one measurable lesion according to RECIST 1.1 criteria.
• • ECOG physical condition score: 0-1 point.
• • Adequate organ and bone marrow function.
• • Ability to understand and voluntarily provide written informed consent before trial participation.
• Cohort-specific Inclusion Criteria:
• Cohort 1:
• • Failure of prior standard therapy, intolerance to standard therapy, ineligibility for standard therapy, or absence of a standard treatment regimen.
• • Life expectancy ≥3 months.
• Cohort 2:
• • Newly diagnosed, treatment-naïve lung adenocarcinoma confirmed by pathology (histology/cytology).
• • Resectable disease classified as stage IB-IIIA per AJCC 9th edition criteria.
• • KRAS G12C/G12D/G12V/G13D mutation-positive by genomic testing.
• Exclusion Criteria:
• • Patients with a history of other malignancies.
• • Presence of primary central nervous system (CNS) tumors, active CNS metastatic tumors, or carcinomatous meningitis, either historically or identified during screening.
• • Uncontrolled moderate to massive serous cavity effusion.
• • Confirmed presence of other classic gene variants.
• • Known cardiac clinical symptoms or diseases that are poorly controlled.
• • Unstable thrombotic events (e.g., deep vein thrombosis, arterial thrombosis, pulmonary embolism) requiring therapeutic intervention within 6 months prior to screening.
• • Any active autoimmune disease or a history of autoimmune disease.
• • Uncontrolled clinical disorders, psychiatric illnesses, or other significant diseases as assessed by the investigator that may interfere with informed consent, compromise interpretation of trial results, pose risks to participants, or otherwise hinder the achievement of trial objectives.
• • History of interstitial pneumonia or suspected interstitial pneumonia; or pulmonary abnormalities that may interfere with the detection or management of suspected drug-related pulmonary toxicity during the trial.
• • Hypersensitivity to the investigational drug (including any excipients).
• • Patients who received anti-tumor therapy within 4 weeks prior to the first dose, or those with unresolved adverse reactions (except alopecia) from prior anti-tumor therapy (NCI CTCAE \> grade 1).
• • Systemic use of corticosteroids (\>10 mg/day prednisone or equivalent) or other immunosuppressants within 14 days prior to the first dose.
• • Participants who received drugs of the same class within 6 months prior to the first dose.
• • Prior organ transplantation or allogeneic hematopoietic stem cell transplantation.
• • Active hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), or syphilis infection.
• • Active tuberculosis (TB) or a history of active TB; or severe acute/chronic infections requiring systemic treatment.
• • Pregnant or lactating women.
• • Any other factors deemed by the investigator to render the participant unsuitable for trial participation.