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Vacuna terapéutica para pacientes con tumores sólidos con determinados tipos de variantes mutantes de KRAS o NRAS: G12D, G12R, G12V, G12A, G12C, G12S, G13D.
Criterios clave de inclusión: para pacientes con una tomografía computarizada que muestre no evidencia de enfermedad recurrente pero que tienen positivo en ADN tumoral circulante y/o biomarcadores tumorales elevados en suero (como CA19-9 y CEA) a pesar de un tratamiento estándar previo que incluya cirugía y quimioterapia/radioterapia, si procede.

ELI-002 2P is a tumor vaccine comprised of a lymph-node targeted amphiphile (AMP)-modified G12D and G12R mutant KRAS peptides together with an AMP-modified CpG oligonucleotide adjuvant. Preliminary antitumor activity in KRAS mutated pancreatic ductal adenocarcinoma.
UPDATE February 2024:
Results regarding CRC and other solid tumors from the phase 1 dose escalation study (AMPLIFY-201, NCT04853017):

“The phase 1 trial involved 25 patients whose pancreatic or colorectal cancer had G12D and G12R KRAS mutations and were at high risk of the cancer returning after surgery. The results demonstrated this vaccine is safe and appears to stimulate the patient’s immune system to create cancer-fighting cells:

• 84% of patients had the desired immune response, meaning that immune T cells targeting KRAS-mutated cancer cells were activated and grew in number.
• Also in 84% of patients, a marker for lingering cancer cells — the amount of tumor DNA circulating in the blood — was reduced. In 24% of patients, the tumor DNA was completely absent.
• Perhaps most significant, patients who had a higher T cell response also experienced a longer time without the disease returning, known as relapse-free survival.”
  (See article in Helpful Links)The vaccine in this trial, NCT05726864, targets more variants than that one: G12D, G12R, G12V, G12A, G12C, G12S, G13D.

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Criterios de inclusión

Criterios de inclusión:

Tumor sólido con mutación KRAS/NRAS (G12D, G12R, G12V, G12A, G12C, G12S, G13D)
Sólo fase 1: positivo para ADN tumoral circulante y/o biomarcadores tumorales elevados en suero (como CA19-9 y CEA) a pesar del tratamiento estándar previo, incluida cirugía y quimioterapia/radioterapia, si procede.
El TAC de cribado es negativo para enfermedad recurrente
Estado funcional 0 ó 1 del Eastern Cooperative Oncology Group (ECOG)

Criterios de exclusión

Criterios de exclusión:

Presencia de mutaciones tumorales para las que se ha aprobado una terapia específica
Metástasis cerebrales conocidas
Uso de fármacos inmunosupresores