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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

AMPLIFY-7P Trial Summary

This trial tests a new cancer therapy to see if it's safe & effective in treating solid tumors with mutated KRAS/NRAS. It builds on experience from a related product.

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.Check my eligibility

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.See study design

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.

AMPLIFY-7P Trial 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.

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My solid tumor has a specific KRAS/NRAS mutation.

AMPLIFY-7P Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

Phase 2: Determine the 1-year DFS

Phase 2: Determine the objective response rate (ORR) in subjects who crossover from Observation to ELI-002 7P treatment after confirmed progressive disease according to iRECIST

+1 more

AMPLIFY-7P 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Elicio TherapeuticsLead Sponsor

1 Previous Clinical Trials

25 Total Patients Enrolled

Media Library

Phase 2 randomized: ELI-002 7P Clinical Trial Eligibility Overview. Trial Name: NCT05726864 — Phase 1 & 2

Neurofibromatosis Research Study Groups: Phase 2 randomized: ELI-002 7P, Phase 1A: ELI-002 7P (Low Peptide dose), Phase 1B: ELI-002 7P, Phase 1A: ELI-002 7P (High Peptide dose)

Neurofibromatosis Clinical Trial 2023: Phase 2 randomized: ELI-002 7P Highlights & Side Effects. Trial Name: NCT05726864 — Phase 1 & 2

Phase 2 randomized: ELI-002 7P 2023 Treatment Timeline for Medical Study. Trial Name: NCT05726864 — Phase 1 & 2

Frequently Asked Questions

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

How many volunteers have joined this investigation?

"To execute this research, Elicio Therapeutics requires 156 eligible patients to be recruited from multiple sites including Northwell Health in Lake Success and Memorial Sloan Kettering Cancer Center. Both of these locations are situated within New york State."

Answered by AI

Are there any open positions in this trial?

"Affirmative. According to clinicaltrials.gov, this scientific trial has resumed recruitment and is seeking 156 people from 4 distinct medical facilities. This research project was first posted on March 1st 2023 with a recent update being applied on the 7th of that same month."

Answered by AI

Are there a copious amount of medical centers conducting the trial in North America?

"Currently, there are 4 sites that have opened recruitment for this trial. These include Lake Success in New york and Houston along with two other medical centres. We advise those interested to select the closest centre available so as to reduce the burden of travelling long distances if they decide to take part."

Answered by AI

What kind of results is this investigation intended to yield?

"As stated by the study sponsor, Elicio Therapeutics, the primary outcome that will be tracked over a 28 day period post first dose of ELI-002 7P is relapse-free survival (RFS) in comparison to Observation. Additionally, safety metrics such as Adverse Events and clinically significant laboratory tests/vital signs will also be monitored. Furthermore, objective response rate (ORR) for those who cross from Observation to ELI-002 7P treatment after confirmed progression and biomarker clearance or reduction are other objectives this trial aims to measure."

Answered by AI

Who else is applying?

What site did they apply to?

University of Pennsylvania

What portion of applicants met pre-screening criteria?

Met criteria

Why did patients apply to this trial?

Stage 4 crc. Have Mets in abdominal muscle due to implants from laparoscopic surgery. Want to do trials before chemo fails. Have been on capox, folfiri, avastin and currently on capcetabine and avastin.

PatientReceived no prior treatments

Recent research and studies

clinicaltrials.govStudy

A Study of ELI-002 7P in Subjects With KRAS/NRAS Mutated Solid Tumors

2023. "A Study of ELI-002 7P in Subjects With KRAS/NRAS Mutated Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05726864.

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