Back to resultsA Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors (AMPLIFY-201)
Primary Purpose
Minimal Residual Disease, KRAS G12D, KRAS G12R
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ELI-002 2P
Sponsored by
About this trial
This is an interventional treatment trial for Minimal Residual Disease focused on measuring Minimal residual disease (MRD), Kirsten rat sarcoma (KRAS), Neuroblastoma ras viral oncogene homolog (NRAS), Pancreatic ductal adenocarcinoma (PDAC), Colorectal cancer (CRC), Colon cancer, Rectal cancer, Non-small-cell lung cancer (NSCLC), Mucinous Ovarian cancer, Cholangiocarcinoma (CCA), Bile duct cancer, Gallbladder carcinoma, Immunotherapy, Vaccine therapy, Adjuvant therapy, circulating tumor DNA (ctDNA)
Eligibility Criteria
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
Sites / Locations
- City of Hope
- University of California Los Angeles
- University of Colorado
- University of Iowa
- Massachusetts General Hospital
- Washington University School of Medicine
- Northwell Health
- Memorial Sloan Kettering Cancer Center
- Tennessee Oncology - Centennial Clinic
- The University of Texas MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
ELI-002 2P Cohort 1
ELI-002 2P Cohort 2
ELI-002 2P Cohort 3
ELI-002 2P Cohort 4
ELI-002 2P Cohort 5
Arm Description
ELI-002 2P Amph-CpG-7909 (0.1 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 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 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 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 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)
Outcomes
Primary Outcome Measures
Determine the MTD of ELI-002 and the RP2D
The MTD is defined as the highest dose level for which <33% of subjects had a dose-limiting toxicity.
Evaluate the safety of ELI-002
Safety will be assessed by the incidence of adverse events (AEs) and clinically significant laboratory tests and vital signs.
Secondary Outcome Measures
Determine the biomarker reduction and clearance rate
The ctDNA reduction and clearance rate is defined as the reduction or clearance of ctDNA , or if ctDNA was not detectable at baseline, serum tumor biomarker reduction or clearance compared to baseline.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04853017
Brief Title
A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors
Acronym
AMPLIFY-201
Official Title
First in Human Phase 1 Trial of ELI-002 Immunotherapy as Treatment for Subjects With Kirsten Rat Sarcoma (KRAS) Mutated Pancreatic Ductal Adenocarcinoma and Other Solid Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 4, 2021 (Actual)
Primary Completion Date
January 26, 2023 (Actual)
Study Completion Date
March 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Elicio Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
Detailed Description
This is a Phase 1 dose escalation study in which ELI-002 2P (Amph modified KRAS peptides, Amph-G12D and Amph-G12R admixed with admixed Amph-CpG-7909) will be evaluated, with plans to transition to the ELI-002 7P drug product containing all 7 Amph-Peptides (G12D, G12R, G12V, G12A, G12C, G12S, G13D) in future clinical trials.
The study is an open-label, dose-escalation, 3+3 design in which approximately 18 subjects will be treated in 3 planned dose level cohorts. Increasing doses of Amph-CpG-7909 will be evaluated sequentially. Additional cohorts may be added to explore intermediate or higher dose levels based on cumulative safety review and preliminary review of pharmcodynamic responses. Safety and pharmacodynamic data will be evaluated and a recommended Phase 2 dose (RP2D) will be determined in consideration of a maximum tolerated dose (MTD) if observed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Minimal Residual Disease, KRAS G12D, KRAS G12R, NRAS G12D, NRAS G12R, Pancreatic Ductal Adenocarcinoma, Colorectal Cancer, Non-small Cell Lung Cancer, Ovarian Cancer, Cholangiocarcinoma, Bile Duct Cancer, Gallbladder Carcinoma
Keywords
Minimal residual disease (MRD), Kirsten rat sarcoma (KRAS), Neuroblastoma ras viral oncogene homolog (NRAS), Pancreatic ductal adenocarcinoma (PDAC), Colorectal cancer (CRC), Colon cancer, Rectal cancer, Non-small-cell lung cancer (NSCLC), Mucinous Ovarian cancer, Cholangiocarcinoma (CCA), Bile duct cancer, Gallbladder carcinoma, Immunotherapy, Vaccine therapy, Adjuvant therapy, circulating tumor DNA (ctDNA)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ELI-002 2P Cohort 1
Arm Type
Experimental
Arm Description
ELI-002 2P Amph-CpG-7909 (0.1 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)
Arm Title
ELI-002 2P Cohort 2
Arm Type
Experimental
Arm Description
ELI-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)
Arm Title
ELI-002 2P Cohort 3
Arm Type
Experimental
Arm Description
ELI-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)
Arm Title
ELI-002 2P Cohort 4
Arm Type
Experimental
Arm Description
ELI-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)
Arm Title
ELI-002 2P Cohort 5
Arm Type
Experimental
Arm Description
ELI-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)
Intervention Type
Drug
Intervention Name(s)
ELI-002 2P
Intervention Description
Amph-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)
Primary Outcome Measure Information:
Title
Determine the MTD of ELI-002 and the RP2D
Description
The MTD is defined as the highest dose level for which <33% of subjects had a dose-limiting toxicity.
Time Frame
28 days after first dose
Title
Evaluate the safety of ELI-002
Description
Safety will be assessed by the incidence of adverse events (AEs) and clinically significant laboratory tests and vital signs.
Time Frame
30 days after last dose
Secondary Outcome Measure Information:
Title
Determine the biomarker reduction and clearance rate
Description
The ctDNA reduction and clearance rate is defined as the reduction or clearance of ctDNA , or if ctDNA was not detectable at baseline, serum tumor biomarker reduction or clearance compared to baseline.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Northwell Health
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Tennessee Oncology - Centennial Clinic
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors
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