Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT07004244

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

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

20

Participants Needed

1

Research Sites

134 weeks

Total Duration

On this page

Sponsors

S

Sichuan University

Lead Sponsor

W

West China Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official 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
  • 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 of at least 3 months
  • Cohort 2: Newly diagnosed, treatment-naive lung adenocarcinoma confirmed by pathology
  • Cohort 2: Resectable disease classified as stage IB-IIIA per AJCC 9th edition
  • Cohort 2: KRAS G12C, G12D, G12V, or 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 metastases, or carcinomatous meningitis
  • Uncontrolled moderate to massive serous cavity effusion
  • Confirmed presence of other classic gene variants
  • Poorly controlled cardiac clinical symptoms or diseases
  • Unstable thrombotic events requiring treatment within 6 months prior to screening
  • Active or history of autoimmune disease
  • Uncontrolled clinical disorders, psychiatric illnesses, or other significant diseases interfering with consent or trial results
  • History or suspicion of interstitial pneumonia or pulmonary abnormalities
  • Hypersensitivity to investigational drug or excipients
  • Anti-tumor therapy within 4 weeks prior to first dose or unresolved adverse reactions except alopecia
  • Systemic corticosteroids (>10 mg/day prednisone or equivalent) or immunosuppressants within 14 days prior to first dose
  • Receipt of drugs of same class within 6 months prior to first dose
  • Prior organ or allogeneic hematopoietic stem cell transplantation
  • Active infections with hepatitis B or C virus, HIV, syphilis, or active 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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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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