ELI-002 Immunotherapy for Pancreatic Cancer

(AMPLIFY-201 Trial)

No longer recruiting at 10 trial locations

Overseen By Clinical Trial Inquiries

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Elicio Therapeutics

Must not be taking: Immunosuppressive drugs

Disqualifiers: Brain metastases, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new immunotherapy treatment called ELI-002 for individuals with certain cancers, such as pancreatic cancer, that have specific genetic mutations. The goal is to determine if this treatment is safe and effective in reducing leftover cancer cells after standard treatments like surgery or chemotherapy. Participants will receive injections of the drug in varying doses to identify the optimal one. Suitable candidates have specific cancer mutations and detectable tumor markers in their blood, but no signs of cancer recurrence on a CT scan. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but you cannot participate if you are using immunosuppressive drugs.

Is there any evidence suggesting that ELI-002 immunotherapy is likely to be safe for humans?

Research shows that ELI-002, a new cancer vaccine, safely enhances the body's immune response against mutated KRAS, a protein often linked to cancer. Studies indicate that ELI-002 can effectively train the immune system to recognize and attack cancer mutations. In earlier studies, the vaccine strongly activated the immune system in nearly all patients tested. However, it is important to note that this is an early-stage study. While this suggests the treatment is generally safe, detailed safety information is still being gathered. Participants undergo monitoring for up to two years to ensure the treatment's safety and effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for pancreatic cancer, which often include chemotherapy and targeted therapies, ELI-002 is an innovative immunotherapy. Researchers are excited about ELI-002 because it targets specific KRAS mutations common in pancreatic cancer, using a combination of Amph-CpG-7909 and modified KRAS peptides. This approach aims to harness the body's own immune system to selectively attack cancer cells, potentially offering a more personalized and less toxic treatment option. Additionally, the subcutaneous injection delivery method is designed to be more convenient and less invasive than traditional intravenous chemotherapy.

What evidence suggests that ELI-002 immunotherapy could be an effective treatment for pancreatic cancer?

Research shows that ELI-002 targets specific changes in pancreatic cancer cells, triggering a strong immune response against them. Studies have found that this treatment successfully activated T-cells, crucial for fighting cancer, in up to 99% of patients with pancreatic ductal adenocarcinoma (PDAC). In another study, 68% of patients had a strong T-cell response, indicating that the immune system was effectively prepared to attack cancer cells. Additionally, patients treated with ELI-002 experienced better outcomes, with longer periods without cancer recurrence compared to those who did not receive this treatment. These results highlight ELI-002’s potential to help manage pancreatic cancer by using the body's own defenses. Participants in this trial will receive different dosages of ELI-002 to evaluate its effectiveness and safety. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

A CT scan does not show signs of the disease coming back.

My blood tests show cancer markers despite having had surgery and/or chemotherapy/radiation.

My tumor has a KRAS or NRAS mutation.

Exclusion Criteria

I am currently taking drugs that suppress my immune system.

I have cancer that has spread to my brain.

My tumor has a mutation for which there is an approved treatment, and I can receive this treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Immunization

Participants receive ELI-002 2P via SC injection weekly for 4 weeks, followed by bi-weekly injections over 4 weeks

8 weeks

Weekly and bi-weekly visits for injections

Booster

Participants receive additional SC injections weekly for 4 consecutive weeks after a 3-month break

4 weeks

Weekly visits for injections

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• ELI-002

Trial Overview

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.

How Is the Trial Designed?

Group I: ELI-002 2P Cohort 5 Experimental Treatment 1 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 4 Experimental Treatment 1 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 3 Experimental Treatment 1 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 2 Experimental Treatment 1 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 1 Experimental Treatment 1 Intervention

ELI-002 2P Amph-CpG-7909 (0.1 mg) admixed with Amph modified KRAS peptides (Amph-G12D and Amph-G12R) administered via subcutaneous (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)

Who Is Running the Clinical Trial?

Elicio Therapeutics

Lead Sponsor

Trials

2

Recruited

180+

Published Research Related to This Trial

The combination of GVAX vaccine with nivolumab and urelumab significantly increased the number of activated CD8+ CD137+ T cells in tumors, indicating a robust immune response, and was well-tolerated by patients.

While the median disease-free and overall survival rates were numerically improved with the combination therapy compared to other treatment arms, the results were not statistically significant, suggesting that further studies are needed to confirm these promising findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A platform trial of neoadjuvant and adjuvant antitumor vaccination alone or in combination with PD-1 antagonist and CD137 agonist antibodies in patients with resectable pancreatic adenocarcinoma. Heumann, T., Judkins, C., Li, K., et al.[2023]

A study analyzing 2,364 cases of pancreatic adverse events (AEs) linked to immune checkpoint inhibitors (ICIs) found significant associations, particularly with ICI-associated pancreatitis and diabetes mellitus, indicating a notable risk for patients undergoing ICI treatment.

Combination therapy with ICIs showed a higher frequency of pancreatic AEs compared to monotherapy, suggesting that while the risk of these adverse events increases, the fatality rate remains lower, highlighting the importance of patient awareness regarding these potential side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pancreatic Adverse Events Associated With Immune Checkpoint Inhibitors: A Large-Scale Pharmacovigilance Analysis. Zhang, Y., Fang, Y., Wu, J., et al.[2022]

Pancreatic cancer is highly lethal due to its immune privilege, characterized by an immunosuppressive environment and poor T cell infiltration, making traditional immunotherapies less effective.

Emerging evidence suggests that combining different immunotherapy strategies, such as checkpoint blockade and engineered T cells, may enhance treatment efficacy for pancreatic cancer, highlighting the need for innovative approaches in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunotherapy and Prevention of Pancreatic Cancer. Morrison, AH., Byrne, KT., Vonderheide, RH.[2023]

In a study of 1535 patients receiving high-dose interleukin-2 (IL-2) therapy, those who experienced immune-related adverse events (irAEs) had significantly better tumor control (71% vs. 56%) and overall survival, particularly in metastatic melanoma (median 48 months vs. 18 months) and metastatic renal cell cancer (median 60 months vs. 40 months).

The majority of irAEs were related to IL-2 therapy, primarily manifesting as vitiligo and thyroid dysfunction, indicating that while these adverse events are concerning, they may also signal a beneficial immune response that enhances treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved survival and tumor control with Interleukin-2 is associated with the development of immune-related adverse events: data from the PROCLAIMSM registry. Curti, B., Daniels, GA., McDermott, DF., et al.[2018]

In a case series of seven patients treated with immune checkpoint inhibitors (ICIs), two developed diabetic ketoacidosis (DKA) and five experienced pancreatitis, highlighting the potential for serious pancreatic adverse events associated with ICI therapy.

Pancreatitis was often asymptomatic and could be managed effectively by holding the ICI treatment and administering steroids, with some patients able to safely resume ICI therapy after recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pancreatic adverse events in patients treated with immune checkpoint inhibitors. Hana, C., Rehman, T., Park, K., et al.[2023]

Pancreatic cancer is a highly lethal disease, ranking as the seventh leading cause of cancer-related deaths globally, highlighting the urgent need for more effective treatments.

Recent studies suggest that immunotherapy could be a promising approach for treating pancreatic cancer, with various preclinical and clinical trials showing encouraging results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Status of Immunotherapy Treatments for Pancreatic Cancer. Jimenez-Luna, C., Prados, J., Ortiz, R., et al.[2018]

A 43-year-old woman with advanced pancreatic cancer experienced immune-related encephalopathy as a side effect of toripalimab combined with chemotherapy, highlighting the potential for serious neurological adverse events during treatment.

The patient's symptoms, including stuttering and MRI findings of cerebral white matter changes, resolved after stopping toripalimab and administering corticosteroids, emphasizing the importance of monitoring for rare neurological side effects in patients receiving immune checkpoint inhibitors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stuttering as a signal of encephalopathy associated with toripalimab in a pancreatic ductal adenocarcinoma patient: a case report. He, J., Chen, X., Cheng, K., et al.[2023]

Citations

1.

nature.com

nature.com/articles/s41591-025-03876-4

Lymph node-targeted, mKRAS-specific amphiphile vaccine ...

We present the final results of the phase 1 AMPLIFY-201 trial, in which patients who completed standard locoregional treatment, with minimal ...

2.

elicio.com

elicio.com/pipeline/eli-002/

Targeting mKRAS With ELI-002 Cancer Vaccine

Preliminary data have shown that ELI-002 produces a potent mKRAS-specific T-cell response, including both CD4+ and CD8+ populations, that correlates with tumor ...

3.

onclive.com

onclive.com/view/eli-002-7p-shows-potential-to-address-unmet-need-in-pancreatic-ductal-adenocarcinoma

ELI-002 7P Shows Potential to Address Unmet Need in ...

ELI-002 7P demonstrated robust mKRAS-specific T-cell responses in 99% of evaluable PDAC patients, indicating significant immune activation. The ...

4.

mdanderson.org

mdanderson.org/newsroom/research-newsroom/final-trial-data-from-eli-002-cancer-immunotherapy-vaccine-reinforce-promising-results.h00-159778812.html

Final trial data from ELI-002 cancer immunotherapy ...

Long-term final follow-up data of this vaccine, ELI-002 2P, now shows that 17 of 25 patients (68%) had robust T cell responses, which were ...

5.

uclahealth.org

uclahealth.org/news/release/shelf-cancer-vaccine-elicits-strong-immune-response-patients

Off-the-shelf cancer vaccine elicits strong immune ...

For example, median relapse-free survival was not reached versus 3.02 months, and median overall survival was not reached versus 15.98 months ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04853017

NCT04853017 | A Study of ELI-002 in Subjects With KRAS ...

This is a Phase 1 study to assess the safety and efficacy of ELI-002 immunotherapy (a lipid-conjugated immune-stimulatory oligonucleotide [Amph-CpG-7909]