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

ConditionMalignant Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSichuan University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • KRAS-mutated mRNA vaccine

    Biological/Vaccine

    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

  • TORIPALIMAB

    Biological/Vaccine

    intravenous injection

  • Pemetrexed+carboplatin

    Drug

    intravenous injection

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Cohort 1Experimental treatment 1 intervention
Group B: Cohort 2Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Adverse events

Adverse events defined as the number of participants with adverse events according to CTCAE v5.0.

Time frame
up to 12 months
2

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

Secondary outcomes

1

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
2

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
3

Overall Survival

OS is defined as the time from the administration of the first dose to death.

Time frame
up to 12 months
4

Pathological response rates

Major pathological response (MPR, defined as ≤10% residual viable tumor); Pathological complete response (pCR)

Time frame
up to 7 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sichuan University

Lead sponsor

West China Hospital

Collaborator

Source ClinicalTrials.gov
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