ELI-002 for Colorectal Cancer

(AMPLIFY-7P Trial)

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

158 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{11 12 13 14 15}

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.

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 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.

Participant Groups

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+

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.

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

References

1. China pubmed.ncbi.nlm.nih.gov

[ARV-7: A biomarker for the treatment of metastatic castration-resistant prostate cancer]. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Optimal timing of chemotherapy in androgen independent prostate cancer. [2018]

3. United States 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. [2022]

4. Japan 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. [2022]

5. Japan 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. [2022]

6. Japan pubmed.ncbi.nlm.nih.gov

Chemoprevention of colorectal cancer in Japan: a brief introduction to current clinical trials. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Current chemoprevention approaches in Lynch syndrome and Familial adenomatous polyposis: a global clinical practice survey. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Chemoprevention of colorectal cancer. [2022]

9. Japan 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. [2021]

10. England pubmed.ncbi.nlm.nih.gov

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]

12. China pubmed.ncbi.nlm.nih.gov

Effects of tyrosine kinase inhibitor E7080 and eNOS inhibitor L-NIO on colorectal cancer alone and in combination. [2021]

13. England 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. [2021]

14. England pubmed.ncbi.nlm.nih.gov

The number of high-risk factors is related to outcome in stage II colonic cancer patients. [2011]

15. Netherlands pubmed.ncbi.nlm.nih.gov

Risk factors for the recurrence of stage II perforated colorectal cancer: A retrospective observational study. [2022]