ELI-002 Immunotherapy for Pancreatic Cancer

(AMPLIFY-201 Trial)

Recruiting at 9 trial locations

Overseen By Clinical Trial Inquiries

Age: 18+

Sex: Any

Trial Phase: Phase 1

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: Unknown

25 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new immunotherapy called ELI-002. It targets patients with specific genetic mutations in their cancer. The treatment works by helping the immune system recognize and attack these cancer cells.

Do I need to stop my current medications for the trial?

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

What data supports the effectiveness of the treatment ELI-002 for pancreatic cancer?

Research on similar immunotherapies for pancreatic cancer, like the GVAX vaccine combined with other immune-boosting agents, has shown promising results in increasing survival and activating immune cells that fight cancer. Additionally, studies on immune checkpoint inhibitors, which are a type of immunotherapy, have shown potential in slowing disease progression and improving survival in pancreatic cancer, suggesting that ELI-002 might also be effective. ^{1 2 3 4 5}

What safety data exists for ELI-002 Immunotherapy for Pancreatic Cancer?

The safety of immune therapies like ELI-002, which may work similarly to other immune checkpoint inhibitors, can include risks of immune-related side effects such as issues with the pancreas, skin, and digestive system. These side effects have been observed in treatments for various cancers, not just pancreatic cancer. ^{6 7 8 9 10}

How is the ELI-002 treatment different from other treatments for pancreatic cancer?

ELI-002 is an immunotherapy that aims to enhance the body's immune response against pancreatic cancer, which is known for its ability to evade the immune system. Unlike traditional treatments, ELI-002 may involve novel strategies such as combining immune stimulatory complexes with other agents to break the tumor's immune evasion, potentially offering a new approach to treating this challenging cancer. ^{2 11 12 13 14}

Eligibility Criteria

This trial is for people with certain solid tumors like pancreatic, lung, or colorectal cancer that have a specific KRAS/NRAS mutation. They should have minimal remaining cancer after standard treatment and be in good physical condition. Those with approved treatments available, brain metastases, or on immunosuppressive drugs can't join.

Inclusion Criteria

A CT scan does not show signs of the disease coming back.

My blood tests show cancer markers despite having had surgery and/or chemotherapy/radiation.

My tumor has a KRAS or NRAS mutation.

Exclusion Criteria

I am currently taking drugs that suppress my immune system.

I have cancer that has spread to my brain.

My tumor has a mutation for which there is an approved treatment, and I can receive this treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Immunization

Participants receive ELI-002 2P via SC injection weekly for 4 weeks, followed by bi-weekly injections over 4 weeks

8 weeks

Weekly and bi-weekly visits for injections

Booster

Participants receive additional SC injections weekly for 4 consecutive weeks after a 3-month break

4 weeks

Weekly visits for injections

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• ELI-002

Trial Overview The study tests ELI-002 immunotherapy as an additional treatment to target any leftover cancer cells in patients who've already had surgery and possibly chemo/radiation. It combines immune-stimulating components designed to help the body fight off remaining cancer cells.

Participant Groups

Group I: ELI-002 2P Cohort 5 Experimental Treatment 1 Intervention

ELI-002 2P Amph-CpG-7909 (10.0 mg) admixed with Amph modified KRAS peptides (Amph-G12D and Amph-G12R) administered via SC injection weekly for 4 consecutive weeks, followed by bi-weekly injections over 4 weeks, during the Immunization period; additional SC injections weekly for 4 consecutive weeks during the Booster Period (the two periods are separated by 3 months of no dosing)

Group II: ELI-002 2P Cohort 4 Experimental Treatment 1 Intervention

ELI-002 2P Amph-CpG-7909 (5.0 mg) admixed with Amph modified KRAS peptides (Amph-G12D and Amph-G12R) administered via SC injection weekly for 4 consecutive weeks, followed by bi-weekly injections over 4 weeks, during the Immunization period; additional SC injections weekly for 4 consecutive weeks during the Booster Period (the two periods are separated by 3 months of no dosing)

Group III: ELI-002 2P Cohort 3 Experimental Treatment 1 Intervention

ELI-002 2P Amph-CpG-7909 (2.5 mg) admixed with Amph modified KRAS peptides (Amph-G12D and Amph-G12R) administered via SC injection weekly for 4 consecutive weeks, followed by bi-weekly injections over 4 weeks, during the Immunization period; additional SC injections weekly for 4 consecutive weeks during the Booster Period (the two periods are separated by 3 months of no dosing)

Group IV: ELI-002 2P Cohort 2 Experimental Treatment 1 Intervention

ELI-002 2P Amph-CpG-7909 (0.5 mg) admixed with Amph modified KRAS peptides (Amph-G12D and Amph-G12R) administered via SC injection weekly for 4 consecutive weeks, followed by bi-weekly injections over 4 weeks, during the Immunization period; additional SC injections weekly for 4 consecutive weeks during the Booster Period (the two periods are separated by 3 months of no dosing)

Group V: ELI-002 2P Cohort 1 Experimental Treatment 1 Intervention

ELI-002 2P Amph-CpG-7909 (0.1 mg) admixed with Amph modified KRAS peptides (Amph-G12D and Amph-G12R) administered via subcutaneous (SC) injection weekly for 4 consecutive weeks, followed by bi-weekly injections over 4 weeks, during the Immunization period; additional SC injections weekly for 4 consecutive weeks during the Booster Period (the two periods are separated by 3 months of no dosing)

Who Is Running the Clinical Trial?

Elicio Therapeutics

Lead Sponsor

Trials

2

Recruited

180+

Findings from Research

The combination of GVAX vaccine with nivolumab and urelumab significantly increased the number of activated CD8+ CD137+ T cells in tumors, indicating a robust immune response, and was well-tolerated by patients.

While the median disease-free and overall survival rates were numerically improved with the combination therapy compared to other treatment arms, the results were not statistically significant, suggesting that further studies are needed to confirm these promising findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A platform trial of neoadjuvant and adjuvant antitumor vaccination alone or in combination with PD-1 antagonist and CD137 agonist antibodies in patients with resectable pancreatic adenocarcinoma. Heumann, T., Judkins, C., Li, K., et al.[2023]

In a case series of seven patients treated with immune checkpoint inhibitors (ICIs), two developed diabetic ketoacidosis (DKA) and five experienced pancreatitis, highlighting the potential for serious pancreatic adverse events associated with ICI therapy.

Pancreatitis was often asymptomatic and could be managed effectively by holding the ICI treatment and administering steroids, with some patients able to safely resume ICI therapy after recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pancreatic adverse events in patients treated with immune checkpoint inhibitors. Hana, C., Rehman, T., Park, K., et al.[2023]

A study analyzing 2,364 cases of pancreatic adverse events (AEs) linked to immune checkpoint inhibitors (ICIs) found significant associations, particularly with ICI-associated pancreatitis and diabetes mellitus, indicating a notable risk for patients undergoing ICI treatment.

Combination therapy with ICIs showed a higher frequency of pancreatic AEs compared to monotherapy, suggesting that while the risk of these adverse events increases, the fatality rate remains lower, highlighting the importance of patient awareness regarding these potential side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pancreatic Adverse Events Associated With Immune Checkpoint Inhibitors: A Large-Scale Pharmacovigilance Analysis. Zhang, Y., Fang, Y., Wu, J., et al.[2022]

A 43-year-old woman with advanced pancreatic cancer experienced immune-related encephalopathy as a side effect of toripalimab combined with chemotherapy, highlighting the potential for serious neurological adverse events during treatment.

The patient's symptoms, including stuttering and MRI findings of cerebral white matter changes, resolved after stopping toripalimab and administering corticosteroids, emphasizing the importance of monitoring for rare neurological side effects in patients receiving immune checkpoint inhibitors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stuttering as a signal of encephalopathy associated with toripalimab in a pancreatic ductal adenocarcinoma patient: a case report. He, J., Chen, X., Cheng, K., et al.[2023]

In a study of 1535 patients receiving high-dose interleukin-2 (IL-2) therapy, those who experienced immune-related adverse events (irAEs) had significantly better tumor control (71% vs. 56%) and overall survival, particularly in metastatic melanoma (median 48 months vs. 18 months) and metastatic renal cell cancer (median 60 months vs. 40 months).

The majority of irAEs were related to IL-2 therapy, primarily manifesting as vitiligo and thyroid dysfunction, indicating that while these adverse events are concerning, they may also signal a beneficial immune response that enhances treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved survival and tumor control with Interleukin-2 is associated with the development of immune-related adverse events: data from the PROCLAIMSM registry. Curti, B., Daniels, GA., McDermott, DF., et al.[2018]

Pancreatic cancer is highly lethal due to its immune privilege, characterized by an immunosuppressive environment and poor T cell infiltration, making traditional immunotherapies less effective.

Emerging evidence suggests that combining different immunotherapy strategies, such as checkpoint blockade and engineered T cells, may enhance treatment efficacy for pancreatic cancer, highlighting the need for innovative approaches in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunotherapy and Prevention of Pancreatic Cancer. Morrison, AH., Byrne, KT., Vonderheide, RH.[2023]

Pancreatic cancer is a highly lethal disease, ranking as the seventh leading cause of cancer-related deaths globally, highlighting the urgent need for more effective treatments.

Recent studies suggest that immunotherapy could be a promising approach for treating pancreatic cancer, with various preclinical and clinical trials showing encouraging results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Status of Immunotherapy Treatments for Pancreatic Cancer. Jimenez-Luna, C., Prados, J., Ortiz, R., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

A platform trial of neoadjuvant and adjuvant antitumor vaccination alone or in combination with PD-1 antagonist and CD137 agonist antibodies in patients with resectable pancreatic adenocarcinoma. [2023]

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

Chemo-immunotherapy mediates durable cure of orthotopic KrasG12D/p53-/- pancreatic ductal adenocarcinoma. [2021]

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

Immune checkpoint therapy for pancreatic cancer. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Intratumoral injection of TLR9 agonist promotes an immunopermissive microenvironment transition and causes cooperative antitumor activity in combination with anti-PD1 in pancreatic cancer. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Immunotherapy in pancreatic cancer treatment: a new frontier. [2022]

6. Australia pubmed.ncbi.nlm.nih.gov

Pancreatic adverse events in patients treated with immune checkpoint inhibitors. [2023]

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

Pancreatic Adverse Events Associated With Immune Checkpoint Inhibitors: A Large-Scale Pharmacovigilance Analysis. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Stuttering as a signal of encephalopathy associated with toripalimab in a pancreatic ductal adenocarcinoma patient: a case report. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Improved survival and tumor control with Interleukin-2 is associated with the development of immune-related adverse events: data from the PROCLAIMSM registry. [2018]

10. China pubmed.ncbi.nlm.nih.gov

[Immune-Related Pancreatitis Caused by Immune Checkpoint Inhibitor Nivolumab:Report of One Case]. [2023]

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

Immunotherapy and Prevention of Pancreatic Cancer. [2023]

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

An ISCOM vaccine combined with a TLR9 agonist breaks immune evasion mediated by regulatory T cells in an orthotopic model of pancreatic carcinoma. [2020]

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

Current Status of Immunotherapy Treatments for Pancreatic Cancer. [2018]

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

Autologous dendritic cells pulsed with allogeneic tumour cell lysate induce tumour-reactive T-cell responses in patients with pancreatic cancer: A phase I study. [2023]