Status:
COMPLETED
A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors
Lead Sponsor:
Elicio Therapeutics
Conditions:
Minimal Residual Disease
KRAS G12D
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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-b...
Detailed Description
This is a Phase 1 dose escalation study in which ELI-002 2P (Amph modified KRAS peptides, Amph-G12D and Amph-G12R admixed with admixed Amph-CpG-7909) will be evaluated, with plans to transition to the...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 24 2024
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04853017
Start Date
October 4 2021
End Date
September 24 2024
Last Update
September 5 2025
Active Locations (10)
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1
City of Hope
Duarte, California, United States, 91010
2
University of California Los Angeles
Los Angeles, California, United States, 90095
3
University of Colorado
Aurora, Colorado, United States, 80045
4
University of Iowa
Iowa City, Iowa, United States, 52242