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

Recruiting now · Phase 1

Conditions studied: Malignant Tumors

In brief

The goal of this study is to evaluate the safety and efficacy of mRNA vaccine for the KRAS mutation malignant tumors.

Key facts

Study ID

NCT07004244

Run by

Sichuan University

People needed

20

Starts

2025-06-05

Expected to finish

2027-12-31

Last updated by the study team

2025-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• West China Hospital, Sichuan University — Chengdu, Sichuan, China (enrolling)

Full record on ClinicalTrials.gov

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