Colon Cancer Clinical Trial

A Study of ELI-002 7P in Subjects With KRAS/NRAS Mutated Solid Tumors

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.

View Full Description

Full Description

The study consists of 3 phases: Phase 1A, Phase 1B, and Phase 2. In Phase 1A, seven Amph modified KRAS and NRAS peptides, G12D, G12R, G12V, G12A, G12C, G12S, G13D (Amph-Peptides 7P) will be evaluated in combination with recommended Phase 2 dose of Amph-CpG-7909 (10.0mg). This Amph-CpG-7909 dose will be evaluated with two Amph-Peptides 7P dose levels (1.4mg and 4.9mg) in 6 subjects per dose level. Following enrollment of these 12 subjects, the independent data monitoring committee (IDMC) will decide if another 6 subjects should be enrolled or if the dose can be determined for Phase 1B and Phase 2 portions of the study to be opened. If another 6 subjects are enrolled to Phase 1A, the IDMC will meet again to decide upon the dose for Phase 1B and Phase 2 prior to opening these portions of the study.

In Phase 1B, one dose expansion cohort of up to 17 colorectal cancer [CRC] subjects may be added to evaluate for preliminary evidence of biomarker response, including circulating tumor deoxyribonucleic acid (ctDNA) and/or serum tumor biomarker (such as CA19-9 and CEA) reduction and clearance in KRAS and NRAS.

In Phase 2, an additional 135 PDAC subjects will be randomized 2:1 (ELI-002 7P versus observation) to further evaluate antitumor activity. Subjects randomized to ELI-002 7P will receive subcutaneous (SC) injections of ELI-002 7P during Immunization and Booster Periods. Subjects randomized to observation will have the same safety and efficacy evaluations and will follow the same assessment schedule as subjects randomized to ELI-002 7P but will not receive study treatment. Subjects randomized to observation will be able to elect to cross-over to ELI-002 7P treatment in the event of confirmed disease progression.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

KRAS/NRAS mutated (G12D, G12R, G12V, G12A, G12C, G12S, G13D) solid tumor
Phase 1 only: positive for circulating tumor DNA and/or elevated serum tumor biomarkers (such as CA19-9 and CEA) 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
Known brain metastases
Use of immunosuppressive drugs

Study is for people with:

Colon Cancer

Phase:

Phase 1

Estimated Enrollment:

156

Study ID:

NCT05726864

Recruitment Status:

Recruiting

Sponsor:

Elicio Therapeutics

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 16 Locations for this study

See Locations Near You

Mayo Clinic Comprehensive Cancer Center
Phoenix Arizona, 85054, United States More Info
Jacob Broach
Contact
[email protected]
Rochelle Quinonez
Contact
[email protected]
Tanios Bekaii-Saab, MD
Principal Investigator
City of Hope
Duarte California, 91010, United States More Info
Vincent Chung, MD
Contact
626-218-9200
[email protected]
Xiomara Anaya
Contact
626-218-9780
Vincent Chung, MD
Principal Investigator
University of California Los Angeles
Los Angeles California, 90095, United States More Info
Lisa Yonemoto
Contact
310-633-8400
[email protected]
Zev Wainberg, MD
Principal Investigator
University of California, Irvine
Orange California, 92868, United States More Info
Jennifer Valerin, MD, PhD
Contact
Jennifer Valerin, MD, PhD
Principal Investigator
University of Colorado Hospital-Anschutz Cancer Pavillion
Aurora Colorado, 80045, United States More Info
McKenna Russen
Contact
303-724-9836
[email protected]
Alexis Leal, MD
Principal Investigator
University of Florida Health Cancer Center
Gainesville Florida, 32610, United States More Info
Ashley Gregorek
Contact
352-265-5124
Thomas George, MD, FACP
Principal Investigator
Mayo Clinic Comprehensive Cancer Center
Jacksonville Florida, 32224, United States More Info
Qandeel Anwar
Contact
[email protected]
Jesse Vines
Contact
904-953-4209
[email protected]
Umair Majeed, MBBS, MD
Principal Investigator
Moffitt Cancer Center
Tampa Florida, 33612, United States More Info
Lauren Ponto
Contact
813-745-7658
[email protected]
DaeWon Kim, MD
Principal Investigator
University of Iowa
Iowa City Iowa, 52242, United States More Info
Chandrikha Chandrasekaharan, MBBS
Contact
[email protected]
Chandrikha Chandrasekaharan, MBBS
Principal Investigator
Massachusetts General Hospital
Boston Massachusetts, 02210, United States More Info
Colin D Weekes, MD
Contact
617-724-4000
[email protected]
Colin D Weekes, MD
Principal Investigator
Mayo Clinic Comprehensive Cancer Center
Rochester Minnesota, 55905, United States More Info
Ryan Car, MD
Contact
[email protected]
Preston Buechler
Contact
507-422-5917
[email protected]
Ryan Carr, MD
Principal Investigator
Northwell Health
Lake Success New York, 11042, United States More Info
Craig Devoe, MD
Contact
516-734-8896
[email protected]
Craig Devoe, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
New York New York, 10022, United States More Info
Eileen M O'Reilly, MD
Contact
646-888-4182
Eileen O'Reilly, MD
Principal Investigator
New York Presbyterian Weill Cornell Medical Center
New York New York, 10065, United States More Info
Casey Owens
Contact
646-962-6046
[email protected]
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States More Info
Mark O'Hara, MD
Contact
215-360-0919
[email protected]
Luda Mazaleuskaya
Contact
1-267-455-9141
[email protected]
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Shubham Pant, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 1

Estimated Enrollment:

156

Study ID:

NCT05726864

Recruitment Status:

Recruiting

Sponsor:


Elicio Therapeutics

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.