ELI-002 for Colorectal Cancer

(AMPLIFY-7P Trial)

Not currently recruiting at 27 trial locations

Overseen By Clinical Trial Inquiries

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

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: 12

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ELI-002 7P to determine its safety and effectiveness for individuals with colorectal cancer and certain other solid tumors. The focus is on tumors with specific gene mutations known as KRAS or NRAS. Participants will receive the treatment through injections over several weeks, with breaks in between. This trial may suit individuals whose cancer has a KRAS/NRAS mutation and who have undergone some standard treatments but still show signs of cancer in blood tests. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that ELI-002 7P is likely to be safe for humans?

Research has shown that ELI-002 7P has promising safety results from earlier studies. In one study, most participants tolerated the treatment well, and it triggered strong immune responses against the KRAS mutation, often found in colorectal cancer.

The study found that ELI-002 7P was safe, with most people experiencing only mild to moderate side effects. These results suggest that the treatment could be a safe option for people with certain types of cancer, although it is still under investigation. Ongoing research aims to confirm these findings and further explore its effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for colorectal cancer?

Researchers are excited about ELI-002 7P for colorectal cancer because it targets the disease in a novel way. Unlike standard chemotherapy or targeted therapies, which typically attack cancer cells directly or interfere with specific molecules, ELI-002 7P is an innovative immunotherapy that stimulates the body's immune system to recognize and fight cancer cells. This is achieved through a unique combination of peptides and an adjuvant, boosting the immune response. This approach has the potential to offer more personalized and effective treatment, especially for patients who may not respond well to traditional therapies.

What evidence suggests that ELI-002 7P might be an effective treatment for colorectal cancer?

Research has shown that ELI-002 7P, studied in this trial, may effectively treat cancers with mutated KRAS/NRAS genes. Studies found that ELI-002 7P activated the immune system in 99% of patients, enabling it to target cancer cells. Earlier versions, like ELI-002 2P, demonstrated strong immune responses in 68% of patients and positive reactions in 84% of participants. These responses are crucial because they suggest the treatment can help prevent cancer recurrence. Overall, early results indicate that ELI-002 7P could effectively fight cancer by harnessing the body's immune system. ^{2 4 5 6 7}

Are You a Good Fit for This Trial?

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.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• ELI-002 7P

Trial Overview 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.

How Is the Trial Designed?

Group I: Phase 2 randomized: ELI-002 7P Experimental Treatment 1 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 7P Experimental Treatment 1 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 Treatment 1 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 Treatment 1 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)

Who Is Running the Clinical Trial?

Elicio Therapeutics

Lead Sponsor

Trials

2

Recruited

180+

Published Research Related to This Trial

Long-term treatment with docetaxel and prednisolone is feasible and can be safely administered to selected patients with castration-resistant prostate cancer (CRPC), as shown in a study involving 15 patients who received an average of 8 additional cycles after an initial 10 cycles.

While some patients experienced significant toxicities, including myelosuppression and infections, there were no treatment-related deaths, and some patients maintained their clinical responses, indicating potential benefits of extended treatment in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Nishimura, K., Nonomura, N., Hashine, K., et al.[2022]

In a study using the Apc(Min/+) mouse model, the combination of the ERbeta-selective agonist silymarin (SIL) and lignin (LIG) significantly reduced intestinal tumor development when added to a high-fat/low-fiber diet, suggesting a protective role of ERbeta in colorectal cancer (CRC).

The treatment with SIL and LIG not only decreased the number and volume of polyps but also restored normal levels of epithelial cell proliferation, apoptosis, and migration, indicating a potential therapeutic strategy for preventing CRC progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary-induced ERbeta upregulation counteracts intestinal neoplasia development in intact male ApcMin/+ mice. Barone, M., Tanzi, S., Lofano, K., et al.[2010]

E7080 demonstrated a strong ability to inhibit the growth of colorectal cancer cells (HT29) with an IC50 value of 5.60×10(-8) mol/L, showing significant antiangiogenic and apoptotic effects.

Combining E7080 with L-NIO enhanced its effectiveness in reducing cancer cell proliferation and promoting apoptosis, suggesting that this combination could allow for lower doses of E7080, potentially reducing side effects in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of tyrosine kinase inhibitor E7080 and eNOS inhibitor L-NIO on colorectal cancer alone and in combination. Altun, A., Temiz, TK., Balcı, E., et al.[2021]

In a study involving 61 patients with familial adenomatous polyposis (FAP), the selective COX-2 inhibitor tiracoxib (JTE-522) did not lead to any significant changes in the number or size of colorectal polyps after 26 weeks of treatment.

Despite being well tolerated, the results suggest that moderate doses of COX-2 inhibitors like JTE-522 do not effectively induce regression of adenomas in FAP patients within a 6-month period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Iwama, T., Akasu, T., Utsunomiya, J., et al.[2021]

Docetaxel (DOC) therapy significantly improves overall survival (OS) in Japanese patients with castration-resistant prostate cancer (CRPC), with a median OS of 94 months compared to 70 months for those receiving conventional androgen-deprivation therapy (ADT).

Higher doses of DOC (≥70 mg/m²) also lead to longer OS compared to lower doses and control, with no reported deaths due to DOC therapy, indicating it is a safe and effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Shimabukuro, T., Sakano, S., Matsuda, K., et al.[2022]

Patients with inflammatory bowel diseases and inherited cancer syndromes like familial adenomatous polyposis (FAP) and Lynch syndrome are at a high risk for colorectal cancer and require tailored prevention strategies.

Chemopreventive drugs such as sulindac, aspirin, celecoxib, and mesalazine have been tested for their effectiveness in these high-risk groups, but their mechanisms of action must align with the specific pathways of cancer development in each condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemoprevention of colorectal cancer. Lang, M., Gasche, C.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Japan is facing a rising incidence of colorectal cancer, prompting the Ministry of Health to prioritize preventive strategies, including funding large-scale chemoprevention studies.

Two ongoing double-blind randomized controlled trials (J-CAPP and J-FAPP II) are investigating the safety and efficacy of low-dose aspirin (100 mg/day) in preventing colorectal cancer in high-risk patients, which is considered safe for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemoprevention of colorectal cancer in Japan: a brief introduction to current clinical trials. Ishikawa, H., Nakamura, T., Kawano, A., et al.[2021]

In a study of 319 patients with colorectal cancer and metastatic liver lesions, combined treatments including surgery, radiofrequency ablation (RFA), and microwave ablation (MWA) significantly improved survival rates, with 5-year survival after liver resection at 24.6%.

Minimally invasive techniques like RFA and MWA not only increased the resectability of tumors to 35-40% but also reduced surgical risks for critically ill patients, demonstrating their efficacy in managing liver metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Combined treatment of colorectal cancer followed by metastatic liver injury]. Prazdnikov, EN., Sizova, AN., Svetashov, VS., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimal timing of chemotherapy in androgen independent prostate cancer. Schnadig, ID., Beer, TM.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[ARV-7: A biomarker for the treatment of metastatic castration-resistant prostate cancer]. Chen, ZY., Dong, Q., Liu, LR., et al.[2020]

A survey of 96 hereditary cancer experts revealed that 69% offer chemoprevention strategies for patients with Lynch syndrome (LS) and familial adenomatous polyposis (FAP), indicating a strong interest in preventive measures for these high-risk groups.

While most professionals discuss and recommend chemoprevention, particularly aspirin, there is significant variability in practices, including the lack of consensus on dosage and factors influencing recommendations, highlighting the need for standardized guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current chemoprevention approaches in Lynch syndrome and Familial adenomatous polyposis: a global clinical practice survey. Mraz, KA., Hodan, R., Rodgers-Fouche, L., et al.[2023]

Adjuvant chemotherapy significantly improves overall survival, disease-specific survival, and disease-free survival in high-risk Stage II colorectal cancer patients, with a hazard ratio of 0.61 for overall survival, based on a meta-analysis of 29 studies involving 183,749 participants.

The benefits of chemotherapy were consistent across various subgroups, including patients with multiple high-risk features and those with colon cancer, indicating that it can be an important treatment option for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative chemotherapy improves survival in patients with resected high-risk Stage II colorectal cancer: results of a systematic review and meta-analysis. Simillis, C., Singh, HKSI., Afxentiou, T., et al.[2021]

In a study of 212 stage II colonic cancer patients, four independent high-risk factors (age, obstruction, perforation, and lymphangio-invasion) were identified that significantly influence the likelihood of recurrent or metastatic disease.

Patients with two or more high-risk factors had a notably lower three-year disease-free survival rate (75.9%) compared to those with one (87.6%) or no high-risk factors (90.4%), highlighting the need for careful assessment and potential adjuvant chemotherapy for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The number of high-risk factors is related to outcome in stage II colonic cancer patients. Koebrugge, B., Vogelaar, FJ., Lips, DJ., et al.[2011]

Patients with perforated colorectal cancer (PCRC) had a significantly higher recurrence rate (41%) compared to those with non-perforated tumors (18%) after R0 surgery, indicating that perforation is a critical factor in cancer recurrence.

The study found that local recurrences were more common in the PCRC group (86% of recurrences), suggesting that tumor cell dispersal due to perforation may contribute to this increased risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for the recurrence of stage II perforated colorectal cancer: A retrospective observational study. Asano, H., Fukano, H., Takagi, M., et al.[2022]

Citations

1. elicio.com elicio.com/press_releases/elicio-therapeutics-reports-eli-002-7p-achieved-robust-mkras-specific-t-cell-responses-in-99-of-evaluable-patients-in-ongoing-phase-2-amplify-7p-trial/

Elicio Therapeutics Reports ELI-002 7P Achieved Robust ... ELI-002 induced mKRAS-specific T cell responses in 99% of evaluable patients (89 of 90) who were treated with the investigational vaccine ...

2. 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 ...

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

Off-the-shelf cancer vaccine elicits strong immune ... The findings Link is external, published in Nature Medicine, show that the vaccine, called ELI-002 2P, can trigger powerful and lasting immune ...

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

Lymph node-targeted, mKRAS-specific amphiphile vaccine ... At a median follow-up of 19.7 months, efficacy correlated with mKRAS-specific T cell responses above or below a threshold 9.17-fold increase ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.2636

AMPLIFY-7P, a first-in-human safety and efficacy trial of ... Earlier ELI-002 2P showed high rates of T cell and tumor biomarker response (both 21/25, 84%), with median relapse-free survival not reached ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05726864

A Study of ELI-002 7P in Subjects With KRAS/NRAS ... This is a Phase 1/2 study to assess the safety and efficacy of ELI-002 7P immunotherapy (a lipid-conjugated immune-stimulatory oligonucleotide ...

7. elicio.com elicio.com/pipeline/eli-002/

Targeting mKRAS With ELI-002 Cancer Vaccine ELI-002 is a novel cancer vaccine that could harness the power of lymph nodes to elicit potent immune responses and target mKRAS with greater potency and ...