Trial Title:
A Study of ELI-002 7P in Subjects With KRAS/NRAS Mutated Solid Tumors
NCT ID:
NCT05726864
Condition:
Pancreatic Ductal Adenocarcinoma
Colorectal Cancer
KRAS G12D
KRAS G12R
KRAS G12V
KRAS G12A
KRAS G12C
KRAS G12S
KRAS G13D
NRAS G12D
NRAS G12R
NRAS G12V
NRAS G12C
NRAS G12S
Conditions: Official terms:
Colorectal Neoplasms
Adenocarcinoma
Conditions: Keywords:
Kirsten rat sarcoma (KRAS)
Neuroblastoma ras viral oncogene homolog (NRAS)
Pancreatic ductal adenocarcinoma (PDAC)
Colorectal cancer (CRC)
Colon cancer
Rectal cancer
Immunotherapy
Vaccine therapy
Adjuvant therapy
serum tumor biomarker
Carbohydrate antigen 19-9 (CA19-9)
Carcinoembryonic antigen (CEA)
circulating tumor DNA (ctDNA)
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ELI-002 7P
Description:
ELI-002 Amph-CpG-7909 admixed with ELI-002 Amph-Peptides 7P administered via SC injection
weekly for 4 consecutive weeks, followed by bi-weekly injections over 4 weeks, during the
Immunization Period; additional SC injections weekly for 4 weeks during the Booster
Period (the two periods are separated by 2 months of no dosing)
Arm group label:
Phase 1A: ELI-002 7P (High Peptide dose)
Arm group label:
Phase 1A: ELI-002 7P (Low Peptide dose)
Arm group label:
Phase 1B: ELI-002 7P
Arm group label:
Phase 2 randomized: ELI-002 7P
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.
Detailed 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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Banner MD Anderson Cancer Center
Address:
City:
Gilbert
Zip:
85234
Country:
United States
Status:
Recruiting
Contact:
Last name:
Angel Tameron
Email:
angel.tameron@bannerhealth.com
Contact backup:
Last name:
Palee Swisher
Email:
palee.swisher@bannerhealth.com
Investigator:
Last name:
Madappa Kundranda, MD
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic Comprehensive Cancer Center
Address:
City:
Phoenix
Zip:
85054
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jose Silva
Email:
Silva.Jose2@mayo.edu
Contact backup:
Last name:
Rochelle Quinonez
Email:
quinonez.rochelle@mayo.edu
Investigator:
Last name:
Tanios Bekaii-Saab, MD
Email:
Principal Investigator
Facility:
Name:
City of Hope
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Vincent Chung, MD
Phone:
626-218-9200
Email:
vchung@coh.org
Contact backup:
Last name:
Xiomara Anaya
Phone:
626-218-9780
Phone ext:
89782
Investigator:
Last name:
Vincent Chung, MD
Email:
Principal Investigator
Facility:
Name:
Cedars-Sinai Medical Center
Address:
City:
Los Angeles
Zip:
90048
Country:
United States
Status:
Recruiting
Contact:
Last name:
Abrahm Levi
Phone:
310-248-8084
Email:
abrahm.levi@cshs.org
Contact backup:
Last name:
Zachariah Brown
Phone:
310-423-5618
Email:
zachariah.brown@cshs.org
Investigator:
Last name:
Andrew Hendifar, MD
Email:
Principal Investigator
Facility:
Name:
University of California Los Angeles
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lisa Yonemoto
Phone:
310-633-8400
Phone ext:
16045
Email:
lyonemoto@mednet.ucla.edu
Investigator:
Last name:
Zev Wainberg, MD
Email:
Principal Investigator
Facility:
Name:
University of California, Irvine
Address:
City:
Orange
Zip:
92868
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jennifer Valerin, MD, PhD
Contact backup:
Phone:
877-827-8839
Email:
ucstudy@uci.edu
Investigator:
Last name:
Jennifer Valerin, MD, PhD
Email:
Principal Investigator
Facility:
Name:
University of Colorado Hospital-Anschutz Cancer Pavillion
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Recruiting
Contact:
Last name:
McKenna Russen
Phone:
303-724-9836
Email:
mckenna.russen@cuanschutz.edu
Investigator:
Last name:
Alexis Leal, MD
Email:
Principal Investigator
Facility:
Name:
University of Miami
Address:
City:
Coral Gables
Zip:
33124
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yolanda Justal
Email:
yxj512@med.miami.edu
Contact backup:
Last name:
Peter J Hosein, MD
Email:
phosein@med.miami.edu
Investigator:
Last name:
Peter J Hosein, MD
Email:
Principal Investigator
Facility:
Name:
University of Florida Health Cancer Center
Address:
City:
Gainesville
Zip:
32610
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ashley Gregorek
Phone:
352-265-5124
Contact backup:
Email:
Phase1@cancer.ufl.edu
Investigator:
Last name:
Thomas George, MD, FACP
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic Comprehensive Cancer Center
Address:
City:
Jacksonville
Zip:
32224
Country:
United States
Status:
Recruiting
Contact:
Last name:
Qandeel Anwar
Email:
anwar.qandeel@mayo.com
Contact backup:
Last name:
Jesse Vines
Phone:
904-953-4209
Email:
vines.jesse@mayo.edu
Investigator:
Last name:
Umair Majeed, MBBS, MD
Email:
Principal Investigator
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lauren Ponto
Phone:
813-745-7658
Email:
lauren.ponto@moffitt.org
Investigator:
Last name:
DaeWon Kim, MD
Email:
Principal Investigator
Facility:
Name:
Emory Winship Cancer Institute
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Recruiting
Contact:
Last name:
Katie Coleman
Phone:
404-251-1278
Email:
kathleen.marie.coleman@emory.edu
Contact backup:
Last name:
Ariana Satcher
Phone:
404-778-8201
Email:
ariana.satcher@emoryhealthcare.org
Investigator:
Last name:
Olumide B Gbolahan, MBBS, MSc
Email:
Principal Investigator
Facility:
Name:
University of Iowa
Address:
City:
Iowa City
Zip:
52242
Country:
United States
Status:
Recruiting
Contact:
Last name:
Naomi H Fei, MD
Email:
naomi-fei@uiowa.edu
Investigator:
Last name:
Naomi H Fei, MD
Email:
Principal Investigator
Facility:
Name:
Ochsner Health
Address:
City:
New Orleans
Zip:
70121
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jonathan Mizrahi, MD
Phone:
504-842-3910
Email:
jonathan.mizrahi@ochsner.org
Contact backup:
Last name:
Kristin Tassin
Phone:
504-842-3929
Email:
kristin.tassin@ochsner.org
Investigator:
Last name:
Jonathan Mizrahi, MD
Email:
Principal Investigator
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Colin D Weekes, MD
Phone:
617-724-4000
Email:
cdweekes@mgh.harvard.edu
Investigator:
Last name:
Colin D Weekes, MD
Email:
Principal Investigator
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Harshabad Singh, MBBS
Phone:
857-215-1345
Email:
harshabad.singh@dfci.harvard.edu
Investigator:
Last name:
Harshabad Singh, MBBS
Email:
Principal Investigator
Facility:
Name:
University of Michigan
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Status:
Recruiting
Contact:
Last name:
CancerAnswerLine@med.umich.edu
Phone:
800-865-1125
Investigator:
Last name:
Vaibhav Sahai, MBBS, MS
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic Comprehensive Cancer Center
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ryan Carr, MD
Email:
carr.ryan@mayo.edu
Contact backup:
Last name:
Preston Buechler
Phone:
507-422-5917
Email:
buechler.preston@mayo.edu
Investigator:
Last name:
Ryan Carr, MD
Email:
Principal Investigator
Facility:
Name:
Northwell Health
Address:
City:
Lake Success
Zip:
11042
Country:
United States
Status:
Recruiting
Contact:
Last name:
Craig Devoe, MD
Phone:
516-734-8896
Email:
cdevoe@northwell.edu
Contact backup:
Email:
ci-phasei_clinicaltrialsunit@northwell.edu
Investigator:
Last name:
Craig Devoe, MD
Email:
Principal Investigator
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10022
Country:
United States
Status:
Recruiting
Contact:
Last name:
Eileen M O'Reilly, MD
Phone:
646-888-4182
Investigator:
Last name:
Eileen O'Reilly, MD
Email:
Principal Investigator
Facility:
Name:
New York Presbyterian Weill Cornell Medical Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Casey Owens
Phone:
646-962-6046
Email:
cdo4001@med.cornell.edu
Facility:
Name:
Lehigh Valley Health Network
Address:
City:
Allentown
Zip:
18003
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alexandra Bauman
Phone:
610-402-0581
Email:
alexandra_l.bauman@lvhn.org
Investigator:
Last name:
Suresh G Nair, MD
Email:
Principal Investigator
Facility:
Name:
University of Pennsylvania
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mark O'Hara, MD
Phone:
215-360-0919
Email:
mark.ohara@pennmedicine.upenn.edu
Contact backup:
Last name:
Luda Mazaleuskaya
Phone:
1-267-455-9141
Email:
mazali@pennmedicine.upenn.edu
Facility:
Name:
Sarah Cannon Research Institute
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trial Inquiries
Phone:
844-482-4812
Investigator:
Last name:
Meredith Pelster, MD, MSCI
Email:
Principal Investigator
Facility:
Name:
Vanderbilt University Medical Center
Address:
City:
Nashville
Zip:
37212
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trial Inquiries
Phone:
800-811-8480
Email:
CTIP@VUMC.org
Investigator:
Last name:
Dana B Cardin, MD
Email:
Principal Investigator
Facility:
Name:
University of Texas Southwestern
Address:
City:
Dallas
Zip:
75390
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ellen Siglinsky
Phone:
214-645-9684
Email:
ellen.siglinsky@utsouthwestern.edu
Contact backup:
Last name:
Pauline Phan
Phone:
214-852-0731
Email:
pauline.phan@utsouthwestern.edu
Investigator:
Last name:
Syed Kazmi, MD
Email:
Principal Investigator
Facility:
Name:
The University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Email:
GIClinicalTrials@mdanderson.org
Investigator:
Last name:
Shubham Pant, MD
Email:
Principal Investigator
Facility:
Name:
Medical College of Wisconsin
Address:
City:
Milwaukee
Zip:
53226
Country:
United States
Status:
Recruiting
Contact:
Last name:
Colleen Cotter
Phone:
414-805-8839
Email:
cmcotter@mcw.edu
Contact backup:
Last name:
Olivia Gorman
Phone:
414-805-6345
Email:
ogorman@mcw.edu
Investigator:
Last name:
Ben George, MD
Email:
Principal Investigator
Start date:
April 14, 2023
Completion date:
November 2026
Lead sponsor:
Agency:
Elicio Therapeutics
Agency class:
Industry
Source:
Elicio Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05726864
