20 Participants NeededMy employer runs this trial

ELI-002 7P + Tislelizumab for Pancreatic Cancer

Recruiting at 6 trial locations
KS
EO
Overseen ByEileen O'Reilly, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new treatment combination is safe and effective for individuals with pancreatic cancer. It tests ELI-002 7P (an experimental treatment) with a chemotherapy regimen called mFOLFIRINOX, sometimes adding tislelizumab (an immunotherapy). The focus is on pancreatic ductal adenocarcinoma, a type of pancreatic cancer with a specific genetic mutation known as KRAS. Suitable candidates for this trial have pancreatic cancer with one of the specific KRAS mutations, and the disease must be resectable (removable by surgery). As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that ELI-002 7P is promising in terms of safety. Studies have found that ELI-002 7P is generally well-tolerated and can activate strong immune responses, which is encouraging. In patients with certain types of cancer, including those with KRAS mutations, no major safety issues have been reported. This suggests that the treatment does not cause serious side effects for most people.

Tislelizumab, another treatment in the study, has already received approval for some cancer treatments, indicating it has passed safety checks for those uses. Although specific safety data for Tislelizumab in this particular trial is not yet available, its existing approval provides some confidence in its safety.

Overall, both treatments appear to have a good safety record based on available data and approvals. Participants considering joining the trial can feel reassured by these findings.12345

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for pancreatic cancer, which often include chemotherapy regimens like mFOLFIRINOX, the combination of ELI-002 7P and Tislelizumab offers a novel approach. ELI-002 7P is a peptide-based vaccine designed to stimulate the immune system to target cancer-specific mutations, potentially enhancing the body's natural defenses against tumor cells. Tislelizumab, on the other hand, is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells more effectively. Researchers are excited because this dual approach not only targets the cancer directly but also boosts the immune response, offering a fresh angle on fighting pancreatic cancer that could improve outcomes for patients.

What evidence suggests that this trial's treatments could be effective for pancreatic cancer?

Research has shown that ELI-002 7P triggers a strong immune response against pancreatic cancer with KRAS mutations, increasing specific T cell activity by an average of 145 times. This means the immune system becomes significantly more active against the cancer. In other studies, 99% of pancreatic cancer patients showed an immune reaction, and 88% responded to their tumor's mutation. In this trial, some participants will receive ELI-002 7P alongside mFOLFIRINOX.

Tislelizumab, a medicine that helps the immune system recognize and attack cancer cells more effectively, has been used successfully in other cancers. It is now being tested in this trial to determine if it can improve outcomes in pancreatic cancer when combined with ELI-002 7P and mFOLFIRINOX. Together, these treatments aim to enhance the body's ability to fight the cancer.16789

Who Is on the Research Team?

KS

Kevin Soares, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for people with pancreatic ductal adenocarcinoma (PDAC) that has a KRAS mutation. Participants should be adults who are healthy enough to receive treatment and meet other basic health requirements set by the study.

Inclusion Criteria

Estimated life expectancy of at least 12 weeks
Patients of reproductive potential must use highly effective contraception from screening through 90 days after last immunotherapy dose
Not pregnant or breastfeeding with evidence of post-menopausal status or negative pregnancy test within 28 days prior to treatment
See 15 more

Exclusion Criteria

I do not have active or recent serious autoimmune or inflammatory diseases.
I have not used strong immune-suppressing drugs in the past 14 days, except for allowed steroids.
I have HIV that does not meet the study's requirements.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive neoadjuvant mFOLFIRINOX and ELI-002 7P, with or without Tislelizumab

16-24 weeks
Visits every 4 weeks for Tislelizumab administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

  • ELI-002 7P
  • mFOLFIRINOX
  • Tislelizumab

Trial Overview

The study is testing ELI-002 7P combined with standard chemotherapy (mFOLFIRINOX), either alone or together with another drug called tislelizumab, to see if these combinations are safe and effective for treating this type of pancreatic cancer.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Tislelizumab in addition to ELI-002 7P and mFOLFIRINOX.Experimental Treatment3 Interventions
Group II: ELI-002 7P concurrent with mFOLFIRINOXActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

BeOne Medicines

Industry Sponsor

Breakthrough Cancer

Collaborator

Elicio Therapeutics

Industry Sponsor

Trials
2
Recruited
180+

Lustgarten Foundation

Collaborator

Trials
27
Recruited
5,500+

Citations

ELI-002 7P Elicits T Cell Responses in Mutant KRAS ...

T cell responses with an average increase of 145.3 times over baseline responses. ELI-002 7P achieved robust mKRAS-specific T cell responses in ...

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 ...

Elicio Therapeutics Announces Positive Recommendation ...

The AMPLIFY-7P study of ELI-002 7P successfully passes event-driven interim analysis for efficacy, futility, and safety by the IDMC

AMPLIFY-7P: Phase 1 and randomized phase 2 study of ...

Methods: This open-label, phase 1 and randomized phase 2 study is evaluating ELI-002 7P in patients with KRAS mutated pancreatic adenocarcinoma ...

NCT04853017 | A Study of ELI-002 in Subjects With KRAS ...

This is a Phase 1 study to assess the safety and efficacy of ELI-002 immunotherapy. Safety and pharmacodynamic data will be evaluated. Mutated Pancreatic ...

AMPLIFY-7P: Phase 1 and randomized phase 2 study of ...

The AMPLIFY-7P study hypothesizes that adjuvant administration of ELI-002 7P will be safe and will delay relapse compared to observation in ...

NCT04853017 | A Study of ELI-002 in Subjects With KRAS ...

This is a Phase 1 study to assess the safety and efficacy of ELI-002 immunotherapy. ELI-002 7P drug product. Safety and pharmacodynamic data will be evaluated ...

Dr Devoe on Safety and Efficacy Data for ELI-002 7P in ...

ELI-002 7P in patients with pancreatic ductal adenocarcinoma (PDAC) cut the risk of death by 50% in first-line PD-L1–positive recurrent or ...

camupepimut (ELI-002 7P) / Elicio Therap

ELI-002 2P was safe and induced considerable T cell responses in patients with immunotherapy-recalcitrant KRAS-mutated tumors.