This is an open-label expanded access protocol (EAP) of ELI-002 7P immunotherapy (a lipid-conjugated immune-stimulatory oligonucleotide \[Amph-CpG-7909\] plus a mixture of lipid-conjugated peptide-based antigens \[Amph-Peptides 7P\]) as adjuvant treatment in patients with KRAS/NRAS-mutated pancreatic ductal adenocarcinoma who are at high risk for relapse (ie, presence of isolated tumor cells in a patient whose primary tumor has been removed and is currently without clinical signs of disease). This protocol builds on the experience being obtained with ELI-002 7P (with Amph-Peptides G12D, G12R, G12V, G12A, G12C, G12S, G13D), which is being studied in protocol ELI-002-201.
Has at least 1 of the 7 KRAS/NRAS mutated alleles (G12D, G12R, G12V, G12A, G12C, G12S, G13D)
The following must be met: (1) the patient has no alternative therapy to diagnose, monitor, or treat the disease or condition; (2) enrollment in a clinical trial is not possible; and (3) the potential benefit to the patient justifies the potential risks of treatment.
Screening CT scan negative for recurrent disease
Eastern Cooperative Oncology Group performance status of 0 or 1
Use of immunosuppressive drugs
Known brain metastases
ELI-002 7P
DrugELI-002 Amph-CpG-7909 (10.0 mg) admixed with ELI-002 Amph-Peptides 7P (4.9 mg) administered via SC injection weekly for 4 consecutive weeks, followed by bi-weekly injections over 4 weeks, during the Immunization Period; additional SC injections weekly for 4 weeks during the Booster Period (the two periods are separated by 2 months of no dosing).
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