A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Othe… (NCT04853017) | Clinical Trial Compass
CompletedPhase 1
A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors
United States25 participantsStarted 2021-10-04
Plain-language summary
This is a Phase 1 study to assess the safety and efficacy of ELI-002 immunotherapy (a lipid-conjugated immune-stimulatory oligonucleotide \[Amph-CpG-7909\] plus a mixture of lipid-conjugated peptide-based antigens \[Amph-Peptides\]) as adjuvant treatment of minimal residual disease (MRD) in subjects with KRAS/neuroblastoma ras viral oncogene homolog (NRAS) mutated PDAC or other solid tumors.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* KRAS/NRAS mutated (G12D or G12R) solid tumor
* Positive for circulating tumor DNA (ctDNA) and/or elevated serum tumor biomarker despite prior standard therapy including surgery and chemotherapy/radiation therapy where applicable
* Screening CT is negative for recurrent disease
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria:
* Presence of tumor mutations where specific therapy is approved, and the patient is able to receive the approved therapy
* Known brain metastases
* Use of immunosuppressive drugs
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial that has already completed, what safety signals or side effects were reported with ELI-002 that I should know about before considering any next steps with this treatment approach?
2This trial focused on people with KRAS mutations like G12D or G12R in minimal residual disease settings — does my tumor have one of these specific mutations, and am I at a stage where a minimal residual disease approach would even be relevant for me?
3Because this was a Phase 1 study primarily designed to test safety rather than prove the treatment works, what would you say is currently known — and not yet known — about whether ELI-002 actually reduces the chance of my cancer coming back?
4Now that this trial is completed, are there any follow-on Phase 2 trials or expanded studies of ELI-002 that might be open and worth looking into, or would standard-of-care treatment be a more proven path for my situation right now?
5How does the idea of targeting minimal residual disease with a vaccine-based approach like ELI-002 compare to other options available to me, especially given that the evidence from this early-phase trial is still limited?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Participant Incidence of Treatment-emergent Adverse Events Considered by the Investigator as Related to ELI-002
Timeframe: Adverse events were collected through 28 days after the last dose