What side effects are associated with this type of intervention?

Common treatments for Neurofibromatosis, particularly those involving immune system stimulation similar to ELI-002 7P immunotherapy, can include side effects such as injection site reactions, flu-like symptoms, fatigue, and gastrointestinal issues. More severe side effects may involve immune-mediated adverse events like inflammation of organs (e.g., colitis, hepatitis), endocrine disorders (e.g., thyroid dysfunction), and skin reactions. It is essential to monitor patients closely for these side effects and manage them promptly.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments for Neurofibromatosis that specifically use immune system stimulation via lipid-conjugated oligonucleotides and peptide-based antigens, similar to ELI-002 7P. However, the FDA has approved other types of treatments for Neurofibromatosis, such as selumetinib (Koselugo), which is a MEK inhibitor used to treat pediatric patients with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas. This treatment works by targeting the MEK pathway rather than directly stimulating the immune system.

What other types of research exist?

Promising novel alternatives to ELI-002 7P immunotherapy for Neurofibromatosis patients in 2024 could include immune modulators like fingolimod and teriflunomide, which have shown potential in attenuating neurodegeneration and reducing neuroinflammation. Additionally, therapies targeting specific pathways, such as hedgehog pathway inhibitors (e.g., sonidegib and vismodegib), may also be considered due to their efficacy in treating other tumor-related conditions.

← Back to Search

ELI-002 for Colorectal Cancer (AMPLIFY-7P Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Elicio Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

KRAS/NRAS mutated (G12D, G12R, G12V, G12A, G12C, G12S, G13D) solid tumor

Must not have

Known brain metastases

Use of immunosuppressive drugs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment called ELI-002 7P for patients with specific types of cancer. The treatment helps the immune system recognize and attack these cancer cells. ELI-002 7P targets mutations that are common in various cancers and have been studied for their role in tumor growth and resistance to treatments.

Who is the study for?

This trial is for people with certain solid tumors that have specific KRAS/NRAS mutations. They should show no signs of recurring disease on a CT scan, and some may need to have tumor DNA or high levels of cancer markers after standard treatments. It's not for those with treatable mutations, brain metastases, or who are taking immunosuppressive drugs.

What is being tested?

The study tests ELI-002 7P immunotherapy in patients with mutated KRAS/NRAS solid tumors. This treatment combines an immune-stimulating molecule (Amph-CpG-7909) with lipid-conjugated peptides (Amph-Peptides 7P), aiming to boost the body's defense against cancer cells.

What are the potential side effects?

While specific side effects aren't listed here, similar immunotherapies can cause flu-like symptoms, injection site reactions, fatigue, allergic responses and possibly affect organ function due to an overactive immune system.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am fully active or can carry out light work.

Select...

My solid tumor has a specific KRAS/NRAS mutation.

Exclusion Criteria

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

Select...

I have cancer that has spread to my brain.

Select...

I am currently taking drugs that suppress my immune system.

Select...

My tumor has mutations that can be treated with approved drugs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Phase 1: Evaluate the safety of ELI-002 7P

Phase 2: Compare ELI-002 7P versus standard of care (SOC; observation) in DFS (disease free survival)

Secondary study objectives

Phase 1 and Phase 2: Determine the biomarker reduction or clearance rate

Phase 2: Determine the 1-year DFS

Phase 2: Evaluate the safety of ELI-002 7P

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Phase 2 randomized: ELI-002 7PExperimental Treatment1 Intervention

The ELI-002 7P dose selected during the Phase 1A portion of the study will be administered via SC injection weekly for 4 consecutive weeks, followed by bi-weekly injections over 4 weeks, during the Immunization Period; additional SC injections for 4 consecutive weeks during the Booster Period (the two periods are separated by 2 months of no dosing)

Group II: Phase 1B: ELI-002 7PExperimental Treatment1 Intervention

Group III: Phase 1A: ELI-002 7P (Low Peptide dose)Experimental Treatment1 Intervention

ELI-002 Amph-CpG-7909 (10.0mg) admixed with ELI-002 Amph-Peptides 7P (1.4mg) administered via SC injection weekly for 4 consecutive weeks, followed by bi-weekly injections over 4 weeks, during the Immunization Period; additional SC injections for 4 consecutive weeks during the Booster Period (the two periods are separated by 2 months of no dosing)

Group IV: Phase 1A: ELI-002 7P (High Peptide dose)Experimental Treatment1 Intervention

ELI-002 Amph-CpG-7909 (10.0mg) admixed with ELI-002 Amph-Peptides 7P (4.9mg) administered via SC injection weekly for 4 consecutive weeks, followed by bi-weekly injections over 4 weeks, during the Immunization Period; additional SC injections for 4 consecutive weeks during the Booster Period (the two periods are separated by 2 months of no dosing)

0 / 5Eligibility 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 most common treatments for Neurofibromatosis, particularly NF2-related schwannomatosis, include bevacizumab and everolimus. Bevacizumab is an antiangiogenic therapy that inhibits vascular endothelial growth factor (VEGF), reducing blood supply to tumors and slowing their growth. Everolimus is an mTORC1 inhibitor that disrupts cell growth and proliferation pathways. These treatments are crucial for Neurofibromatosis patients as they target the underlying mechanisms of tumor growth and proliferation, potentially reducing tumor size and associated symptoms. Immunotherapy approaches, like the ELI-002 7P, which stimulate the immune system using lipid-conjugated oligonucleotides and peptide-based antigens, represent a promising area of research. These therapies aim to enhance the body's immune response to target and destroy tumor cells, offering a novel and potentially effective treatment option for Neurofibromatosis patients.

Exploring and Targeting the Tumor Immune Microenvironment of Neuroblastoma.Immunotherapeutic treatments for spinal and peripheral nerve tumors: a primer.Expanding the Indication for Novel Theranostic 177Lu-Dotatate Peptide Receptor Radionuclide Therapy: Proof-of-Concept of PRRT in Merkel Cell Cancer.