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ELI-002 2P

Phase 1

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

ELI-002 2P development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Apr 2021

ELI-002 2P target and mechanism

Molecular targetKRAS
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

ELI-002 2P clinical trials

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?

ELI-002 2P is an investigational cancer therapy being developed by Elicio Therapeutics, Inc. (ELTX) for minimal residual disease in KRAS-mutated solid tumors. It is a small molecule designed to target KRAS and is in Phase 1 clinical development.

What is ELI-002 2P used for?

ELI-002 2P is being studied for the treatment of minimal residual disease in patients with KRAS-mutated solid tumors, 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 KRAS, specifically KRAS G12D and G12R mutations, as well as NRAS G12D and G12R mutations. It is a small molecule designed to address these specific genetic alterations in solid tumors.

Who is developing ELI-002 2P?

ELI-002 2P is being developed by Elicio Therapeutics, Inc., which trades on the Nasdaq under the ticker symbol ELTX. The company is focused on advancing this therapy for KRAS-mutated cancers.

What phase is ELI-002 2P in?

ELI-002 2P is in Phase 1 clinical development. It is an investigational therapy and has not been approved by the FDA. The Phase 1 trial has been completed.

What clinical trials is ELI-002 2P in?

ELI-002 2P has been evaluated in a Phase 1 clinical trial, NCT04853017, titled "A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors." The trial enrolled 25 participants and has been completed.