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ELI-002 2P

Phase 1

Minimal Residual Disease | Small molecule | Oncology |Elicio Therapeutics, Inc.|Last Updated: Sep 5, 2025

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

ELI-002 2P · 1 trial · 12 indications

Phase 1 1
NCT04853017A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid TumorsMinimal Residual Disease
COMPLETED25 Analytics
PHASE1COMPLETED
A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors
Minimal Residual DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

The Participant Incidence of Treatment-emergent Adverse Events Considered by the Investigator as Related to ELI-002
Adverse events were collected through 28 days after the last dose

The safety of ELI-002 was monitored through adverse events, including those considered related to treatment by the investigator

Secondary Endpoints

The Proportion of Participants With Biomarker Reduction
6 months
The Proportion of Participants With Biomarker Clearance
6 months
The Proportion of Participants With Biomarker Reduction by Biomarker Type
6 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ELI-002 2P Cohort 1EXPERIMENTALELI-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)
ELI-002 2P Cohort 2EXPERIMENTALELI-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)
ELI-002 2P Cohort 3EXPERIMENTALELI-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)
ELI-002 2P Cohort 4EXPERIMENTALELI-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)
ELI-002 2P Cohort 5EXPERIMENTALELI-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)

Interventions

NameTypeDescription
ELI-002 2PDRUGAmph-CpG-7909 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)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites10

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...

Countries:United States
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Frequently asked questions about ELI-002 2P

What is ELI-002 2P used for?

ELI-002 2P is an investigational small molecule being studied for the treatment of minimal residual disease in patients with KRAS-mutated cancers, including pancreatic ductal adenocarcinoma, colorectal cancer, non-small cell lung cancer, ovarian cancer, cholangiocarcinoma, bile duct cancer, and gallbladder carcinoma.

What does ELI-002 2P target?

ELI-002 2P targets cancers with KRAS G12D, KRAS G12R, NRAS G12D, and NRAS G12R mutations. It is designed to address minimal residual disease, which refers to the small number of cancer cells that remain after treatment and can lead to relapse.

Who makes ELI-002 2P?

ELI-002 2P is being developed by Elicio Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol ELTX. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with KRAS-mutated solid tumors.

What phase is ELI-002 2P in?

ELI-002 2P is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to assess its safety, tolerability, and potential efficacy in treating minimal residual disease in KRAS-mutated cancers.

What clinical trials is ELI-002 2P in?

ELI-002 2P has been studied in one completed Phase 1 clinical trial, registered as NCT04853017. This trial enrolled 25 participants with KRAS-mutated pancreatic ductal adenocarcinoma and other solid tumors, and was conducted in the United States with participants aged 18 years and older.

Is ELI-002 2P the same as ELI-002?

ELI-002 2P is a version of the investigational drug ELI-002. The clinical trial NCT04853017, titled 'A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors,' evaluated ELI-002 in patients with minimal residual disease and various KRAS-mutated cancers.