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Cancer Vaccine

ELI-002 Immunotherapy for Pancreatic Cancer (AMPLIFY-201 Trial)

Phase 1
Waitlist Available
Research Sponsored by Elicio Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
KRAS/NRAS mutated (G12D or G12R) solid tumor
Positive for circulating tumor DNA (ctDNA) and/or elevated serum tumor biomarker despite prior standard therapy including surgery and chemotherapy/radiation therapy where applicable
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

AMPLIFY-201 Trial Summary

This trial is testing a new immunotherapy to see if it is safe and effective in treating patients with solid tumors who have a KRAS or NRAS mutation.

Who is the study for?
This trial is for people with certain solid tumors like pancreatic, lung, or colorectal cancer that have a specific KRAS/NRAS mutation. They should have minimal remaining cancer after standard treatment and be in good physical condition. Those with approved treatments available, brain metastases, or on immunosuppressive drugs can't join.Check my eligibility
What is being tested?
The study tests ELI-002 immunotherapy as an additional treatment to target any leftover cancer cells in patients who've already had surgery and possibly chemo/radiation. It combines immune-stimulating components designed to help the body fight off remaining cancer cells.See study design
What are the potential side effects?
As this is an early-phase trial assessing safety and efficacy, potential side effects are being studied but may include typical immune-related reactions such as fatigue, flu-like symptoms, allergic responses, and possible inflammation at the injection site.

AMPLIFY-201 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My tumor has a KRAS or NRAS mutation.
Select...
My blood tests show cancer markers despite having had surgery and/or chemotherapy/radiation.
Select...
I am fully active or can carry out light work.

AMPLIFY-201 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine the MTD of ELI-002 and the RP2D
Evaluate the safety of ELI-002
Secondary outcome measures
Determine the biomarker reduction and clearance rate

AMPLIFY-201 Trial Design

5Treatment groups
Experimental Treatment
Group I: ELI-002 2P Cohort 5Experimental Treatment1 Intervention
ELI-002 2P Amph-CpG-7909 (10.0 mg) admixed with Amph modified KRAS peptides (Amph-G12D and Amph-G12R) 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 consecutive weeks during the Booster Period (the two periods are separated by 3 months of no dosing)
Group II: ELI-002 2P Cohort 4Experimental Treatment1 Intervention
ELI-002 2P Amph-CpG-7909 (5.0 mg) admixed with Amph modified KRAS peptides (Amph-G12D and Amph-G12R) 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 consecutive weeks during the Booster Period (the two periods are separated by 3 months of no dosing)
Group III: ELI-002 2P Cohort 3Experimental Treatment1 Intervention
ELI-002 2P Amph-CpG-7909 (2.5 mg) admixed with Amph modified KRAS peptides (Amph-G12D and Amph-G12R) 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 consecutive weeks during the Booster Period (the two periods are separated by 3 months of no dosing)
Group IV: ELI-002 2P Cohort 2Experimental Treatment1 Intervention
ELI-002 2P Amph-CpG-7909 (0.5 mg) admixed with Amph modified KRAS peptides (Amph-G12D and Amph-G12R) 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 consecutive weeks during the Booster Period (the two periods are separated by 3 months of no dosing)
Group V: ELI-002 2P Cohort 1Experimental Treatment1 Intervention
ELI-002 2P Amph-CpG-7909 (0.1 mg) admixed with Amph modified KRAS peptides (Amph-G12D and Amph-G12R) 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 consecutive weeks during the Booster Period (the two periods are separated by 3 months of no dosing)

Find a Location

Who is running the clinical trial?

Elicio TherapeuticsLead Sponsor
1 Previous Clinical Trials
156 Total Patients Enrolled

Media Library

ELI-002 (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04853017 — Phase 1
Bile Duct Cancer Research Study Groups: ELI-002 2P Cohort 2, ELI-002 2P Cohort 3, ELI-002 2P Cohort 4, ELI-002 2P Cohort 5, ELI-002 2P Cohort 1
Bile Duct Cancer Clinical Trial 2023: ELI-002 Highlights & Side Effects. Trial Name: NCT04853017 — Phase 1
ELI-002 (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04853017 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What objectives is this clinical experiment seeking to accomplish?

"This study's primary goal, which will be monitored over a month following the final dosage, is to ascertain the MTD of ELI-002 and its RP2D. Additionally, researchers shall assess ctDNA clearance rates between treatment groups, overall survival times from randomization till death for each group, and 1-year RFS probability among both cohorts."

Answered by AI

Is there still capacity for enrolment into this trial?

"Affirmative. According to the clinicaltrials.gov record, this research is still recruiting subjects and was initially posted on October 4th 2021 with a recent update from November 21st 2022. This endeavor needs 18 contributors across 8 distinct sites."

Answered by AI

Has the ELI-002 2P drug obtained sanction from the FDA?

"Our evaluation at Power put ELI-002 2P's safety level at 1, considering it is only in its initial testing phase with limited evidence of efficacy and security."

Answered by AI

To what extent is the general population participating in this research endeavor?

"A total of 18 eligible patients are required to successfully run the trial, which is administrated by Elicio Therapeutics from multiple locations. These include Massachusetts General Hospital in Boston and University of Colorado in Aurora."

Answered by AI

How many research centers are overseeing this investigation?

"This clinical trial has sites located in Boston, Aurora and Houston as well as 8 additional locations. Specifically, Massachusetts General Hospital, University of Colorado and The University of Texas MD Anderson Cancer Center are all recruiting participants for this study."

Answered by AI

Who else is applying?

What state do they live in?
Wisconsin
Texas
How old are they?
65+
What site did they apply to?
University of Iowa
The University of Texas MD Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors
2021. "A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04853017.
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