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

Program Status

Recruiting

Phase

PHASE2

Immunotherapy-centered Trial

Yes

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.
Location Location Status
United States
Banner MD Anderson Cancer Center
Gilbert, Arizona 85234
RECRUITING
Mayo Clinic Comprehensive Cancer Center
Phoenix, Arizona 85054
RECRUITING
City of Hope
Duarte, California 91010
RECRUITING
Cedars-Sinai Medical Center
Los Angeles, California 90048
RECRUITING
University of California Los Angeles
Los Angeles, California 90095
RECRUITING
University of California, Irvine
Orange, California 92868
RECRUITING
University of Colorado Hospital-Anschutz Cancer Pavillion
Aurora, Colorado 80045
RECRUITING
University of Miami
Coral Gables, Florida 33124
RECRUITING
University of Florida Health Cancer Center
Gainesville, Florida 32610
RECRUITING
Mayo Clinic Comprehensive Cancer Center
Jacksonville, Florida 32224
RECRUITING
Moffitt Cancer Center
Tampa, Florida 33612
RECRUITING
University of Iowa
Iowa City, Iowa 52242
RECRUITING
Ochsner Health
New Orleans, Louisiana 70121
RECRUITING
Massachusetts General Hospital
Boston, Massachusetts 02210
RECRUITING
Dana Farber Cancer Institute
Boston, Massachusetts 02215
RECRUITING
Mayo Clinic Comprehensive Cancer Center
Rochester, Minnesota 55905
RECRUITING
Northwell Health
Lake Success, New York 11042
RECRUITING
Memorial Sloan Kettering Cancer Center
New York, New York 10022
RECRUITING
New York Presbyterian Weill Cornell Medical Center
New York, New York 10065
RECRUITING
Lehigh Valley Health Network
Allentown, Pennsylvania 18003
RECRUITING
University of Pennsylvania
Philadelphia, Pennsylvania 19104
RECRUITING
Sarah Cannon Research Institute
Nashville, Tennessee 37203
RECRUITING
Vanderbilt University Medical Center
Nashville, Tennessee 37212
RECRUITING
University of Texas Southwestern
Dallas, Texas 75390
RECRUITING
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
RECRUITING
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
RECRUITING

Contacts

Clinical Trial Inquiries
CONTACT
617-714-9884 clinicaltrialinquiries@elicio.com

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

2024-07-10