What is the mechanism of action of this treatment?

The ELI-002 immunotherapy targets Minimal Residual Disease (MRD) by using a combination of lipid-conjugated immune-stimulatory oligonucleotides (Amph-CpG-7909) and lipid-conjugated peptide-based antigens (Amph-Peptides). The immune-stimulatory oligonucleotides activate the immune system by mimicking bacterial DNA, thereby stimulating an immune response. The peptide-based antigens are designed to specifically target and mark cancer cells for destruction by the immune system. This dual approach enhances the body's ability to recognize and eliminate residual cancer cells, which is crucial for preventing relapse and achieving long-term remission in MRD patients.

What side effects are associated with this type of intervention?

Treatments for Minimal Residual Disease (MRD) that involve immune stimulation, such as ELI-002 immunotherapy, commonly cause side effects like injection site reactions, flu-like symptoms (fever, chills, fatigue), and gastrointestinal issues (nausea, vomiting). More severe side effects can include immune-related adverse events such as rash, pruritus, and rare autoimmune reactions. Monitoring for excessive immune activation is essential.

What prior FDA approvals exist?

The FDA has approved various immunotherapies for the treatment of Minimal Residual Disease (MRD) in different cancers. These include agents like blinatumomab, a bispecific T-cell engager (BiTE) antibody construct, which has been approved for MRD in B-cell precursor acute lymphoblastic leukemia (ALL). While specific lipid-conjugated oligonucleotide and peptide-based antigen therapies like ELI-002 are still under investigation, other immunotherapies such as checkpoint inhibitors (e.g., pembrolizumab, nivolumab) and CAR-T cell therapies have shown efficacy in targeting residual disease by enhancing the immune system's ability to recognize and destroy cancer cells.

What other types of research exist?

Promising novel alternatives to ELI-002 immunotherapy for MRD patients include: 1) Nivolumab combined with Ipilimumab, which has shown efficacy in adjuvant therapy for melanoma, 2) Durvalumab plus Tremelimumab, particularly for patients with high tumor mutational burden, and 3) Pembrolizumab, which has demonstrated effectiveness in various solid tumors. These therapies leverage immune checkpoint inhibition to enhance anti-tumor immune responses.

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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

Must not have

Use of immunosuppressive drugs

Known brain metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new immunotherapy called ELI-002. It targets patients with specific genetic mutations in their cancer. The treatment works by helping the immune system recognize and attack these cancer cells.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My tumor has a KRAS or NRAS mutation.

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

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking drugs that suppress my immune system.

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I have cancer that has spread to my brain.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine the MTD of ELI-002 and the RP2D

Evaluate the safety of ELI-002

Secondary study objectives

Determine the biomarker reduction and clearance rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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)

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The ELI-002 immunotherapy targets Minimal Residual Disease (MRD) by using a combination of lipid-conjugated immune-stimulatory oligonucleotides (Amph-CpG-7909) and lipid-conjugated peptide-based antigens (Amph-Peptides). The immune-stimulatory oligonucleotides activate the immune system by mimicking bacterial DNA, thereby stimulating an immune response. The peptide-based antigens are designed to specifically target and mark cancer cells for destruction by the immune system. This dual approach enhances the body's ability to recognize and eliminate residual cancer cells, which is crucial for preventing relapse and achieving long-term remission in MRD patients.

Low-Dose Total Skin Electron Beam Therapy as Part of a Multimodality Regimen for Treatment of Sézary Syndrome: Clinical, Immunologic, and Molecular Analysis.Immunological challenges and approaches to immunomodulation in Pompe disease: a literature review.Novel monoclonal antibody-based treatment strategies in adults with acute lymphoblastic leukemia.