A Phase 1 interventional study of KRAS-mutated mRNA vaccine and TORIPALIMAB in Malignant Tumors, sponsored by Sichuan University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-24.
Sponsored by Sichuan University · Phase 1, Interventional, and Treatment
The goal of this study is to evaluate the safety and efficacy of mRNA vaccine for the KRAS mutation malignant tumors.
The Kirsten rat sarcoma viral oncogene homolog (KRAS) is one of the most prevalent oncogenes in humans and plays a pivotal role in tumor initiation and progression. KRAS mutations are observed in various cancers, particularly in non-small cell lung cancer, colorectal cancer, and pancreatic cancer. Mutations in the KRAS gene activate multiple signaling pathways, such as MAPK/ERK and PI3K/AKT, which regulate cell proliferation, survival, and migration, thereby driving tumor progression and the development of drug resistance. Due to its critical role in cancer, KRAS has emerged as a key therapeutic target. However, the structural characteristics of KRAS mutants have historically rendered direct inhibition of the KRAS protein extremely challenging, leading to its designation as an "undruggable" target over the past decades. Consequently, patients with KRAS-mutated malignancies face limited treatment efficacy and a lack of precision therapeutic options. In recent years, advances in scientific technologies have enabled the successful development and marketing of several drugs targeting specific KRAS mutations. Nevertheless, most existing therapies exhibit suboptimal efficacy, necessitating further exploration of treatments for broader mutation types and larger cancer populations.
mRNA vaccines represent a highly promising novel approach in oncology. Preliminary reviews of global clinical trials investigating tumor-related mRNA therapeutics reveal that current research primarily focuses on malignancies such as melanoma, prostate cancer, colorectal cancer, acute myeloid leukemia, and breast cancer, with most studies in Phase I/II. Published data demonstrate that mRNA-based cancer therapies exhibit significant potential in anticancer immunotherapy and favorable safety profiles. Given the promising antitumor efficacy of mRNA therapeutic vaccines targeting KRAS mutations in KRAS-mutated tumors, coupled with the limited treatment options and poor outcomes for most KRAS-mutated cancer patients, monotherapy with mRNA therapeutic vaccines or their combination with immune checkpoint inhibitors may offer substantial clinical benefits. Accordingly, the research team plans to conduct an "Exploratory Study on the Application of mRNA Vaccines Targeting KRAS Mutations in KRAS-Mutated Malignancies."
9,365 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.
This study's planned enrollment of 20 is below the median of 50 across 7,250 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Sichuan University is the lead sponsor of 106 studies on the registry; 65 are open to participants now.
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Key Inclusion Criteria:
Cohort-specific Inclusion Criteria:
Cohort 1:
Cohort 2:
Exclusion Criteria:
From the initial dose, the dose was increased using a dose escalation scheme. Each subject only received one corresponding dose.
Biological: KRAS-mutated mRNA vaccine
KRAS-mutated mRNA vaccine+ Toripalimab + pemetrexed + carboplatin as neo-adjuvant treatment followed by surgery
Biological: KRAS-mutated mRNA vaccine · Biological: TORIPALIMAB · Drug: Pemetrexed+carboplatin
Cohort 1:From the initial dose, the dose was increased using a dose escalation scheme. Each subject only received one corresponding dose. Cohort 2:KRAS-mutated mRNA vaccine+ Toripalimab + pemetrexed + carboplatin as neo-adjuvant treatment followed by surgery
intravenous injection
intravenous injection
Adverse events
Adverse events defined as the number of participants with adverse events according to CTCAE v5.0.
Time frame: up to 12 months
Immunogenicity of the mRNA vaccine
Measure vaccine-induced immune response (e.g., antigen-specific T-cell/B-cell responses or seroconversion rates).
Time frame: up to 7 months
Objective response rate
ORR is defined as the percentage of patients who achieve a response, which can either be complete response (complete disappearance of lesions) or partial response (reduction in the sum of maximal tumor diameters by at least 30% or more)
Time frame: up to 12 months
Progress-Free Survival
PFS is defined as the time from the administration of the first dose to first disease
Time frame: up to 12 months
Overall Survival
OS is defined as the time from the administration of the first dose to death.
Time frame: up to 12 months
Pathological response rates
Major pathological response (MPR, defined as ≤10% residual viable tumor); Pathological complete response (pCR)
Time frame: up to 7 months
Surgical feasibility
R0 resection rate; Incidence of surgery delay or cancellation
Time frame: up to 7 months
Plan to share: No
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Sichuan University