Phase 1
N=25
A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors
Minimal Residual Disease · KRAS G12D · KRAS G12R · NRAS G12D · NRAS G12R
Bottom Line
View on ClinicalTrials.gov: NCT04853017 ↗Enrolled (actual)
25
Serious AEs
8.0%
Results posted
Jan 2025
Primary outcome: Primary: The Participant Incidence of Treatment-emergent Adverse Events Considered by the Investigator as Related to ELI-002 — 1; 3; 2; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- ELI-002 2P (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Elicio Therapeutics
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Participant Incidence of Treatment-emergent Adverse Events Considered by the Investigator as Related to ELI-002 |
1; 3; 2; 2; 4 | — |
| SECONDARY The Proportion of Participants With Biomarker Reduction |
2; 5; 4; 4; 6 | — |
| SECONDARY The Proportion of Participants With Biomarker Clearance |
1; 2; 1; 1; 1 | — |
| SECONDARY The Proportion of Participants With Biomarker Reduction by Biomarker Type |
12; 9 | — |
| SECONDARY The Proportion of Participants With Biomarker Clearance by Biomarker Type |
6; 0 | — |
Summary
This is a Phase 1 study to assess the safety and efficacy of ELI-002 immunotherapy (a lipid-conjugated immune-stimulatory oligonucleotide [Amph-CpG-7909] plus a mixture of lipid-conjugated peptide-based antigens [Amph-Peptides]) as adjuvant treatment of minimal residual disease (MRD) in subjects with KRAS/neuroblastoma ras viral oncogene homolog (NRAS) mutated PDAC or other solid tumors.
Eligibility Criteria
Inclusion Criteria
- KRAS/NRAS mutated (G12D or G12R) solid tumor
- Positive for circulating tumor DNA (ctDNA) and/or elevated serum tumor biomarker despite prior standard therapy including surgery and chemotherapy/radiation therapy where applicable
- Screening CT is negative for recurrent disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria
- Presence of tumor mutations where specific therapy is approved, and the patient is able to receive the approved therapy
- Known brain metastases
- Use of immunosuppressive drugs
Data sourced from ClinicalTrials.gov (NCT04853017). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.