158 Participants Needed

ELI-002 for Colorectal Cancer

(AMPLIFY-7P Trial)

Recruiting at 27 trial locations
CT
Overseen ByClinical Trial Inquiries
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Elicio Therapeutics
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications, but you cannot use immunosuppressive drugs.

Will I have to stop taking my current medications?

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

What data supports the idea that ELI-002 for Colorectal Cancer is an effective treatment?

The available research does not provide any data on the effectiveness of ELI-002 for Colorectal Cancer. Instead, the studies focus on treatments for prostate cancer, specifically castration-resistant prostate cancer, and do not mention ELI-002 or its effectiveness for colorectal cancer or any other condition.12345

What safety data is available for ELI-002 in colorectal cancer treatment?

The provided research does not contain specific safety data for ELI-002, ELI-002 7P, or ELI-002 2P in the context of colorectal cancer treatment. The studies mentioned focus on other chemopreventive drugs and strategies, such as low-dose aspirin, COX-2 inhibitors, and dietary interventions, but do not address ELI-002 or its variants.678910

Is the drug ELI-002 a promising treatment for colorectal cancer?

The information provided does not directly mention ELI-002, so we can't determine if it's a promising treatment for colorectal cancer based on these articles.1112131415

Eligibility Criteria

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.

Inclusion Criteria

The CT scan does not show any signs of the disease coming back.
I am fully active or can carry out light work.
My solid tumor has a specific KRAS/NRAS mutation.
See 1 more

Exclusion Criteria

I have cancer that has spread to my brain.
I am currently taking drugs that suppress my immune system.
My tumor has mutations that can be treated with approved drugs.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1A

Evaluation of Amph-Peptides 7P with Amph-CpG-7909 in subjects to determine dose for subsequent phases

8 weeks
Weekly SC injections for 4 weeks, then bi-weekly for 4 weeks

Phase 1B

Dose expansion cohort to evaluate preliminary biomarker response in colorectal cancer subjects

8 weeks
Weekly SC injections for 4 weeks, then bi-weekly for 4 weeks

Phase 2

Randomized evaluation of ELI-002 7P versus observation in PDAC subjects for antitumor activity

20 weeks
Weekly SC injections for 4 weeks, then bi-weekly for 4 weeks, followed by a Booster Period

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

  • ELI-002 7P
Trial OverviewThe 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.
Participant Groups
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
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 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)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Elicio Therapeutics

Lead Sponsor

Trials
2
Recruited
180+

Findings from Research

AR-V7 is a significant biomarker in metastatic prostate cancer, particularly in castration-resistant prostate cancer (CRPC), as its expression is higher in CRPC compared to hormone-naïve prostate cancer and is linked to resistance against common therapies like abiraterone and enzalutamide.
Clinical trials suggest that AR-V7 levels in circulating tumor cells can help predict treatment outcomes, with AR-V7 negative patients responding better to new hormonal therapies and taxane chemotherapy, while AR-V7 positive patients may have poorer responses to these treatments.
[ARV-7: A biomarker for the treatment of metastatic castration-resistant prostate cancer].Chen, ZY., Dong, Q., Liu, LR., et al.[2020]
Docetaxel chemotherapy is currently recommended only for patients with metastatic androgen-independent prostate cancer (AIPC) who have not responded to one or more hormonal therapies, as there is no evidence supporting its use in non-metastatic AIPC.
The timing of initiating docetaxel therapy can be personalized based on individual patient risk, clinical status, and preferences, with ongoing studies exploring the potential benefits of earlier chemotherapy in the disease's progression.
Optimal timing of chemotherapy in androgen independent prostate cancer.Schnadig, ID., Beer, TM.[2018]
In a study of 202 patients with castration-resistant prostate cancer (CRPC) undergoing treatment with abiraterone or enzalutamide, the presence of androgen receptor splice variant-7 (AR-V7) in circulating tumor cells (CTCs) was linked to poorer treatment outcomes, highlighting its prognostic significance.
The study established three distinct prognostic categories based on CTC and AR-V7 status: CTC- patients had the best outcomes, CTC+/AR-V7- patients had intermediate outcomes, and CTC+/AR-V7+ patients had the worst outcomes, suggesting that AR-V7 detection can guide treatment decisions.
Clinical Significance of Androgen Receptor Splice Variant-7 mRNA Detection in Circulating Tumor Cells of Men With Metastatic Castration-Resistant Prostate Cancer Treated With First- and Second-Line Abiraterone and Enzalutamide.Antonarakis, ES., Lu, C., Luber, B., et al.[2022]

References

[ARV-7: A biomarker for the treatment of metastatic castration-resistant prostate cancer]. [2020]
Optimal timing of chemotherapy in androgen independent prostate cancer. [2018]
Clinical Significance of Androgen Receptor Splice Variant-7 mRNA Detection in Circulating Tumor Cells of Men With Metastatic Castration-Resistant Prostate Cancer Treated With First- and Second-Line Abiraterone and Enzalutamide. [2022]
Can docetaxel therapy improve overall survival from primary therapy compared with androgen-deprivation therapy alone in Japanese patients with castration-resistant prostate cancer? A multi-institutional cooperative study. [2022]
Prolonged treatment with three-weekly docetaxel plus daily prednisolone for metastatic castration-resistant prostate cancer: a multicenter, phase II, open-label, non-comparative, extension study in Japan. [2022]
Chemoprevention of colorectal cancer in Japan: a brief introduction to current clinical trials. [2021]
Current chemoprevention approaches in Lynch syndrome and Familial adenomatous polyposis: a global clinical practice survey. [2023]
Chemoprevention of colorectal cancer. [2022]
Does a selective cyclooxygenase-2 inhibitor (tiracoxib) induce clinically sufficient suppression of adenomas in patients with familial adenomatous polyposis? A randomized double-blind placebo-controlled clinical trial. [2021]
Dietary-induced ERbeta upregulation counteracts intestinal neoplasia development in intact male ApcMin/+ mice. [2010]
11.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Combined treatment of colorectal cancer followed by metastatic liver injury]. [2019]
Effects of tyrosine kinase inhibitor E7080 and eNOS inhibitor L-NIO on colorectal cancer alone and in combination. [2021]
Postoperative chemotherapy improves survival in patients with resected high-risk Stage II colorectal cancer: results of a systematic review and meta-analysis. [2021]
The number of high-risk factors is related to outcome in stage II colonic cancer patients. [2011]
Risk factors for the recurrence of stage II perforated colorectal cancer: A retrospective observational study. [2022]