NCT07004244 Application of KRAS Vaccine in the Treatment of KRAS-mutated Malignancies
| NCT ID | NCT07004244 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Sichuan University |
| Condition | Malignant Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-06-05 |
| Primary Completion | 2027-12-31 |
Trial Parameters
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Brief Summary
The goal of this study is to evaluate the safety and efficacy of mRNA vaccine for the KRAS mutation malignant tumors.
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) tumor