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

Program Status

Active, not recruiting

Phase

Phase 1 Phase 2

Prior Immunotherapy Allowed

Yes

CRC-directed Trial

Yes

Drugs

ELI-002 7P

Tags

MSI-H/ MMRd, MSS/ MMRp

Comments

Therapeutic vaccine for patients with solid tumors with certain types of KRAS or NRAS mutant variants: G12D, G12R, G12V, G12A, G12C, G12S, G13D.
Key inclusion criteria: for patients with a CT scan that shows no evidence of recurrent disease but who have 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.

ELI-002 2P is a tumor vaccine comprised of a lymph-node targeted amphiphile (AMP)-modified G12D and G12R mutant KRAS peptides together with an AMP-modified CpG oligonucleotide adjuvant. Preliminary antitumor activity in KRAS mutated pancreatic ductal adenocarcinoma.
UPDATE February 2024:
Results regarding CRC and other solid tumors from the phase 1 dose escalation study (AMPLIFY-201, NCT04853017):

“The phase 1 trial involved 25 patients whose pancreatic or colorectal cancer had G12D and G12R KRAS mutations and were at high risk of the cancer returning after surgery. The results demonstrated this vaccine is safe and appears to stimulate the patient’s immune system to create cancer-fighting cells:

84% of patients had the desired immune response, meaning that immune T cells targeting KRAS-mutated cancer cells were activated and grew in number.
Also in 84% of patients, a marker for lingering cancer cells — the amount of tumor DNA circulating in the blood — was reduced. In 24% of patients, the tumor DNA was completely absent.
Perhaps most significant, patients who had a higher T cell response also experienced a longer time without the disease returning, known as relapse-free survival.”
(See article in Helpful Links)The vaccine in this trial, NCT05726864, targets more variants than that one: G12D, G12R, G12V, G12A, G12C, G12S, G13D.

Helpful Links

Lymph-node-targeted, mKRAS-specific amphiphile vaccine in pancreatic and colorectal cancer: the phase 1 AMPLIFY-201 trial Amphiphile Lymph Node–Targeted Vaccine Is Safe and Bolsters T-Cell Responses in MRD+ PDAC and CRC AMPLIFY-7P, a first-in-human safety and efficacy trial of adjuvant mKRAS-specific lymph node targeted amphiphile ELI-002 7P vaccine in patients with minimal residual disease–positive pancreatic and colorectal cancer.

Location	Location Status
United States
Banner MD Anderson Cancer Center Gilbert, Arizona 85234	Active, not recruiting
Mayo Clinic Comprehensive Cancer Center Phoenix, Arizona 85054	Active, not recruiting
City of Hope Duarte, California 91010	Active, not recruiting
Cedars-Sinai Medical Center Los Angeles, California 90048	Active, not recruiting
University of California Los Angeles Los Angeles, California 90095	Active, not recruiting
University of California, Irvine Orange, California 92868	Active, not recruiting
University of Colorado Hospital-Anschutz Cancer Pavillion Aurora, Colorado 80045	Active, not recruiting
University of Miami Coral Gables, Florida 33124	Active, not recruiting
University of Florida Health Cancer Center Gainesville, Florida 32610	Active, not recruiting
Mayo Clinic Comprehensive Cancer Center Jacksonville, Florida 32224	Active, not recruiting
Moffitt Cancer Center Tampa, Florida 33612	Active, not recruiting
Emory Winship Cancer Institute Atlanta, Georgia 30322	Active, not recruiting
University of Iowa Iowa City, Iowa 52242	Active, not recruiting
Ochsner Health New Orleans, Louisiana 70121	Active, not recruiting
Massachusetts General Hospital Boston, Massachusetts 02210	Active, not recruiting
Dana Farber Cancer Institute Boston, Massachusetts 02215	Active, not recruiting
University of Michigan Ann Arbor, Michigan 48109	Active, not recruiting
Mayo Clinic Comprehensive Cancer Center Rochester, Minnesota 55905	Active, not recruiting
Northwell Health Lake Success, New York 11042	Active, not recruiting
Memorial Sloan Kettering Cancer Center New York, New York 10022	Active, not recruiting
New York Presbyterian Weill Cornell Medical Center New York, New York 10065	Active, not recruiting
Lehigh Valley Health Network Allentown, Pennsylvania 18003	Active, not recruiting
University of Pennsylvania Philadelphia, Pennsylvania 19104	Active, not recruiting
Sarah Cannon Research Institute Nashville, Tennessee 37203	Active, not recruiting
Vanderbilt University Medical Center Nashville, Tennessee 37212	Active, not recruiting
University of Texas Southwestern Dallas, Texas 75390	Active, not recruiting
The University of Texas MD Anderson Cancer Center Houston, Texas 77030	Active, not recruiting
Medical College of Wisconsin Milwaukee, Wisconsin 53226	Active, not recruiting

Inclusion 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

Exclusion Criteria:

* Presence of tumor mutations where specific therapy is approved
* Known brain metastases
* Use of immunosuppressive drugs

NCT ID

NCT05726864

Date Trial Added

2023-02-14

Updated Date

2024-12-27

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