Expanded Access Protocol of ELI-002-102 in Subjects With KRAS/NRAS Mutated Pancreatic Ductal Adenocarcinoma

NCT07083479 | Unknown

• 1 other identifier: ELI-002-102
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

KRAS G12C; KRAS G12R; KRAS G13D; NRAS G12D; NRAS G12V; NRAS G12S; NRAS G12A; NRAS G12C; NRAS G12R; NRAS G13D; Pancreatic Ductal Adenocarcinoma; KRAS G12D; KRAS G12V; KRAS G12S; KRAS G12A

Keywords

Pancreatic ductal adenocarcinoma (PDAC); Kirsten rat sarcoma (KRAS); Neuroblastoma ras viral oncogene homolog (NRAS); Adjuvant therapy; Immunotherapy; Vaccine therapy; Expanded access; Expandd access protocol (EAP)

Interventions

ELI-002 7P DRUG

ELI-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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Use of immunosuppressive drugs
• Known brain metastases

Sponsors & Collaborators

• Elicio Therapeutics: lead

Central Study Contacts

Clinical Trial Inquiries

CONTACT

617-714-9884; clinicaltrialinquiries@elicio.com

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 24, 2025
• Last Updated: March 17, 2026

Record last verified: 2026-03