Actively Recruiting

Phase 1
Age: 18Years +
All Genders
ID07004244

Safety and Efficacy of KRAS Vaccine in the Treatment of KRAS-mutant Malignancies

Led by Sichuan University · Updated on 2025-06-24

20

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

S

Sichuan University

Lead Sponsor

W

West China Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of an mRNA vaccine targeting KRAS mutations in malignant tumors. KRAS mutations play a key role in the development and progression of various cancers such as non-small cell lung cancer, colorectal cancer, and pancreatic cancer. Due to the difficulty in directly targeting KRAS proteins, this study explores mRNA vaccines as a promising new treatment option, either alone or combined with immune checkpoint inhibitors, to improve outcomes for patients with KRAS-mutated cancers. The study includes two groups: one receiving escalating doses of the KRAS-mutated mRNA vaccine alone, and another receiving the vaccine combined with Toripalimab, pemetrexed, and carboplatin as a pre-surgery treatment. Participants in the combination group will undergo surgery after this neo-adjuvant treatment. The trial uses a non-randomized design and aims to assess the vaccine's safety and immune response over several months. Participants will be monitored for adverse events for up to 12 months, and immune responses to the vaccine will be assessed for up to 7 months. Researchers will also measure tumor responses, progression-free survival, overall survival, and surgical feasibility. The study involves regular clinical assessments, laboratory tests, and imaging to evaluate treatment effects and safety throughout the participation period, which may last up to a year.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female participants 18 years of age or older
  • Solid tumors confirmed to carry KRAS mutations
  • At least one measurable lesion according to RECIST 1.1 criteria
  • ECOG physical condition score of 0-1 point
  • Adequate organ and bone marrow function
  • Ability to understand and voluntarily provide written informed consent
  • Cohort 1: Failure, intolerance, ineligibility, or absence of standard therapy and life expectancy 3 months or more
  • Cohort 2: Newly diagnosed, treatment-naive lung adenocarcinoma, resectable stage IB-IIIA disease, KRAS G12C/G12D/G12V/G13D mutation-positive by genomic testing
Not Eligible

You will not qualify if you...

  • History of other malignancies
  • Presence of primary CNS tumors, active CNS metastatic tumors, or carcinomatous meningitis
  • Uncontrolled moderate to massive serous cavity effusion
  • Presence of other classic gene variants
  • Poorly controlled cardiac symptoms or diseases
  • Unstable thrombotic events requiring treatment within 6 months
  • Active or past autoimmune disease
  • Uncontrolled clinical disorders, psychiatric illnesses, or other significant diseases
  • History or suspicion of interstitial pneumonia or pulmonary abnormalities
  • Hypersensitivity to the investigational drug or excipients
  • Anti-tumor therapy within 4 weeks prior to first dose or unresolved adverse reactions (except alopecia)
  • Systemic corticosteroids or immunosuppressants within 14 days before first dose
  • Use of drugs from same class within 6 months before first dose
  • Prior organ or hematopoietic stem cell transplantation
  • Active infections including hepatitis B, hepatitis C, HIV, syphilis, tuberculosis
  • Pregnant or lactating women
  • Any other factors deemed unsuitable by investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

screening and enrollment visit

Treatment

Duration - Up to 7 months

Participants receive either a KRAS-mutated mRNA vaccine alone with dose escalation or a combination of KRAS-mutated mRNA vaccine, Toripalimab, pemetrexed, and carboplatin as neo-adjuvant treatment followed by surgery.

Visits vary by cohort and treatment phase

Follow-up

Duration - Up to 12 months

Participants are monitored for adverse events, immunogenicity, and clinical outcomes including response rates and survival for up to 12 months after treatment.

Periodic visits for up to 12 months

Trial Site Locations

Total: 1 location

1

West China Hospital, Sichuan University

Chengdu, Sichuan, China, 610041

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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