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NCT05726864 · ClinicalTrials.gov registry record · Phase 1
A Study of ELI-002 7P in Subjects With KRAS/NRAS Mutated Solid Tumors
A Phase 1 study of Colorectal Cancer and Pancreatic Ductal Adenocarcinoma, sponsored by Elicio Therapeutics.
- Active
- Registry status
- Phase 1
- Development phase
- 158
- Enrollment target
- 20
- Study locations
NCT05726864: Active Phase 1 study of Colorectal Cancer and Pancreatic Ductal Adenocarcinoma, sponsored by Elicio Therapeutics.
NCT05726864 is a Phase 1 study of Colorectal Cancer and Pancreatic Ductal Adenocarcinoma that is active but no longer recruiting, run by Elicio Therapeutics. The registered enrollment target is 158 participants, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05726864, a Phase 1 study of Colorectal Cancer and Pancreatic Ductal Adenocarcinoma, is active but no longer recruiting, sponsored by Elicio Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 158 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 1/2 study to assess the safety and efficacy 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 subjects with solid tumors with mutated KRAS/NRAS. This study builds on the experience obtained with related product ELI-002 2P, which was studied in protocol ELI-002-001 under IND 26909.
Primary Outcome
Safety will be assessed by the incidence of adverse events (AEs) and clinically significant changes in laboratory tests and vital signs
Conditions Studied
Interventions
- DRUG ELI-002 7P
Study Locations (20)
California
- City of Hope - Duarte
- Cedars-Sinai Medical Center - Los Angeles
- University of California Los Angeles - Los Angeles
- University of California, Irvine - Orange
Florida
- University of Miami - Coral Gables
- University of Florida Health Cancer Center - Gainesville
- Mayo Clinic Comprehensive Cancer Center - Jacksonville
- Moffitt Cancer Center - Tampa
Arizona
- Banner MD Anderson Cancer Center - Gilbert
- Mayo Clinic Comprehensive Cancer Center - Phoenix
Massachusetts
- Massachusetts General Hospital - Boston
- Dana Farber Cancer Institute - Boston
New York
- Northwell Health - Lake Success
- Memorial Sloan Kettering Cancer Center - New York
Colorado
- University of Colorado Hospital-Anschutz Cancer Pavillion - Aurora
Georgia
- Emory Winship Cancer Institute - Atlanta
Iowa
- University of Iowa - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 158 participants |
| Start Date | 2023-04-14 |
| Est. Completion | 2026-11 |
| Phase | Phase 1 |
What the registry record for NCT05726864 still lists
NCT05726864 is an interventional study that assigns participants to a tested intervention. The registered 158 participants enrollment target is mid-sized for trials with a published cap, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (90% lower).
The record links to 10 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 1 intervention - of which ELI-002 7P is the first listed.
NCT05726864 names 20 study sites across 11 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT05726864 about?
NCT05726864 is a clinical study titled "A Study of ELI-002 7P in Subjects With KRAS/NRAS Mutated Solid Tumors". This is a Phase 1/2 study to assess the safety and efficacy 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 subjects with solid tumors with mu...
What is the current status of trial NCT05726864?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 158 participants. The study started on 2023-04-14. Estimated completion is 2026-11.
What conditions does trial NCT05726864 study?
This clinical trial studies the following conditions: Colorectal Cancer, Pancreatic Ductal Adenocarcinoma, Kras G12C, Kras G12D, Kras G12A.
What interventions are being tested in trial NCT05726864?
The interventions under investigation include: ELI-002 7P (DRUG).
Who is sponsoring clinical trial NCT05726864?
This trial is sponsored by Elicio Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05726864 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05726864's enrollment target sits among peer trials
158 168th of 381 higher than 214 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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