Pancreatic Ductal AdenocarcinomaAMPLIFY-EAPNCT07083479
Expanded Access Protocol of ELI-002-102 in Subjects With KRAS/NRAS Mutated Pancreatic Ductal Adenocarcinoma
A study testing ELI-002 7P in people with Pancreatic Ductal Adenocarcinoma and KRAS G12D, run by Elicio Therapeutics.
Trial summary
This is an open-label expanded access protocol (EAP) of ELI-002 7P immunotherapy (a lipid-conjugated immune-stimulatory oligonucleotide [Amph-CpG-7909] plus a mixture of lipid-conjugated peptide-based antigens [Amph-Peptides 7P]) as adjuvant treatment in patients with KRAS/NRAS-mutated pancreatic ductal adenocarcinoma… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma, KRAS G12D, KRAS G12V
- What is being tested?
- ELI-002 7P
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Has at least 1 of the 7 KRAS/NRAS mutated alleles (G12D, G12R, G12V, G12A, G12C, G12S, G13D)
- The following must be met: (1) the patient has no alternative therapy to diagnose, monitor, or treat the disease or condition; (2) enrollment in a clinical trial is not possible; and (3) the potential benefit to the patient justifies the potential risks of treatment.
- Screening CT scan negative for recurrent disease
- Eastern Cooperative Oncology Group performance status of 0 or 1
Who cannot join
- Use of immunosuppressive drugs
- Known brain metastases
About this study
Official title: Expanded Access Protocol for ELI-002 7P Immunotherapy as Treatment for Subjects With Kirsten Rat Sarcoma (KRAS)/Neuroblastoma RAS Viral Oncogene Homolog (NRAS) Mutated Pancreatic Ductal Adenocarcinoma (PDAC)
This is an open-label expanded access protocol (EAP) of ELI-002 7P immunotherapy (a lipid-conjugated immune-stimulatory oligonucleotide [Amph-CpG-7909] plus a mixture of lipid-conjugated peptide-based antigens [Amph-Peptides 7P]) as adjuvant treatment in patients with KRAS/NRAS-mutated pancreatic ductal adenocarcinoma who are at high risk for relapse (ie, presence of isolated tumor cells in a patient whose primary tumor has been removed and is currently without clinical signs of disease). This protocol builds on the experience being obtained with ELI-002 7P (with Amph-Peptides G12D, G12R, G12V, G12A, G12C, G12S, G13D), which is being studied in protocol ELI-002-201.
Read the detailed description
This EAP was designed to provide ELI-002 7P access to patients when all of the following apply: patient has a serious or immediately life-threatening disease or condition; there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition; patient enrollment in a clinical trial is not possible; potential patient benefit justifies the potential risks of treatment; and providing the investigational medical product will not interfere with investigational trials that could support a medical product's development or marketing approval for the treatment indication. In addition, the protocol will include patients participating in Study ELI-002-201 who might benefit from receiving doses beyond the protocol-specified schedule for that study. As such, this EAP will include 2 cohorts: Cohort 1A will include patients unable to participate in other clinical trial protocols and will receive ELI-002 7P for the first time; and Cohort 1B will include patients who have completed the dosing specified in Study ELI-002-201 and are receiving additional booster doses.
The protocol consists of a Screening Period, an Immunization Period, a 2-Month No Dosing Period, a Booster Period, and a Follow-up Period. Patients who have not previously received ELI-002 7P (Cohort 1A) will participate in all periods of the protocol. Patients who have completed previous treatment with ELI-002 7P and are only receiving additional booster doses (Cohort 1B) will skip the Immunization Period and 2-Month No Dosing Period. All patients will receive booster doses unless they have unresolved toxicity (specific to Cohort 1A).
All patients will be observed for safety and tolerability. Laboratory assessments (hematology, blood chemistry), vital signs, physical examinations, and radiographic imaging and other assessments will be performed per institution standard of care practice and per treating physician judgement. Patients with confirmed radiographic relapse (using iRECIST criteria; not judged as pseudoprogression) during treatment with ELI-002 7P may either discontinue trial treatment or continue trial treatment if the treating physician determines that continued use of ELI-002 7P is appropriate treatment for the current clinical situation, the patient is tolerating ELI-002 7P, and the patient has stable performance status.
- Being tested
- ELI-002 7P
- Keywords
- Pancreatic ductal adenocarcinoma (PDAC), Kirsten rat sarcoma (KRAS), Neuroblastoma ras viral oncogene homolog (NRAS), Adjuvant therapy, Immunotherapy, Vaccine therapy, Expanded access, Expandd access protocol (EAP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELI-002 7PDrug
ELI-002 Amph-CpG-7909 (10.0 mg) admixed with ELI-002 Amph-Peptides 7P (4.9 mg) 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 weeks during the Booster Period (the two periods are separated by 2 months of no dosing).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Elicio Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07083479
- Sponsor's protocol ID
- ELI-002-102
- Acronym
- AMPLIFY-EAP
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2025
- Last updated
- 10 Jul 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Protocol for ELI-002 7P Immunotherapy as Treatment for Subjects With Kirsten Rat Sarcoma (KRAS)/Neuroblastoma RAS Viral Oncogene Homolog (NRAS) Mutated Pancreatic Ductal Adenocarcinoma (PDAC)
- ClinicalTrials.gov ID
- NCT07083479
- Acronym / sponsor ID
- AMPLIFY-EAP / ELI-002-102
- Keywords
- Pancreatic ductal adenocarcinoma (PDAC), Kirsten rat sarcoma (KRAS), Neuroblastoma ras viral oncogene homolog (NRAS), Adjuvant therapy, Immunotherapy, Vaccine therapy, Expanded access, Expandd access protocol (EAP)
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Elicio TherapeuticsIndustry (pharma, biotech, devices)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label expanded access protocol (EAP) of ELI-002 7P immunotherapy (a lipid-conjugated immune-stimulatory oligonucleotide [Amph-CpG-7909] plus a mixture of lipid-conjugated peptide-based antigens [Amph-Peptides 7P]) as adjuvant treatment in patients with KRAS/NRAS-mutated pancreatic ductal adenocarcinoma who are at high risk for relapse (ie, presence of isolated tumor cells in a patient whose primary tumor has been removed and is currently without clinical signs of disease). This protocol builds on the experience being obtained with ELI-002 7P (with Amph-Peptides G12D, G12R, G12V, G12A, G12C, G12S, G13D), which is being studied in protocol ELI-002-201.
Detailed description
This EAP was designed to provide ELI-002 7P access to patients when all of the following apply: patient has a serious or immediately life-threatening disease or condition; there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition; patient enrollment in a clinical trial is not possible; potential patient benefit justifies the potential risks of treatment; and providing the investigational medical product will not interfere with investigational trials that could support a medical product's development or marketing approval for the treatment indication. In addition, the protocol will include patients participating in Study ELI-002-201 who might benefit from receiving doses beyond the protocol-specified schedule for that study. As such, this EAP will include 2 cohorts: Cohort 1A will include patients unable to participate in other clinical trial protocols and will receive ELI-002 7P for the first time; and Cohort 1B will include patients who have completed the dosing specified in Study ELI-002-201 and are receiving additional booster doses.
The protocol consists of a Screening Period, an Immunization Period, a 2-Month No Dosing Period, a Booster Period, and a Follow-up Period. Patients who have not previously received ELI-002 7P (Cohort 1A) will participate in all periods of the protocol. Patients who have completed previous treatment with ELI-002 7P and are only receiving additional booster doses (Cohort 1B) will skip the Immunization Period and 2-Month No Dosing Period. All patients will receive booster doses unless they have unresolved toxicity (specific to Cohort 1A).
All patients will be observed for safety and tolerability. Laboratory assessments (hematology, blood chemistry), vital signs, physical examinations, and radiographic imaging and other assessments will be performed per institution standard of care practice and per treating physician judgement. Patients with confirmed radiographic relapse (using iRECIST criteria; not judged as pseudoprogression) during treatment with ELI-002 7P may either discontinue trial treatment or continue trial treatment if the treating physician determines that continued use of ELI-002 7P is appropriate treatment for the current clinical situation, the patient is tolerating ELI-002 7P, and the patient has stable performance status.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Has at least 1 of the 7 KRAS/NRAS mutated alleles (G12D, G12R, G12V, G12A, G12C, G12S, G13D)
- The following must be met: (1) the patient has no alternative therapy to diagnose, monitor, or treat the disease or condition; (2) enrollment in a clinical trial is not possible; and (3) the potential benefit to the patient justifies the potential risks of treatment.
- Screening CT scan negative for recurrent disease
- Eastern Cooperative Oncology Group performance status of 0 or 1
Key exclusion criteria (2 listed)
- Use of immunosuppressive drugs
- Known brain metastases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELI-002 7PELI-002 Amph-CpG-7909 (10.0 mg) admixed with ELI-002 Amph-Peptides 7P (4.9 mg) 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 weeks during the Booster Period (the two periods are separated by 2 months of no dosing). | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ELI-002 7P in people with Pancreatic Ductal Adenocarcinoma and KRAS G12D, run by Elicio Therapeutics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.