A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors

Draft scope assessment: unclear. Attached because the study's own record names KRAS. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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

All enrolled subjects were included in the analysis.

→

secondary · POSTED

A biomarker reduction was any decrease from baseline in circulating tumor DNA (ctDNA) and/or serum tumor antigen levels (carbohydrate antigen 19-9 \[CA19-9\] or carcinoembryonic antigen \[CEA\]).

Source null

→

secondary · POSTED

Biomarker clearance was defined as no detectable ctDNA, CA19-9, or CEA at post-treatment time points.

Source null

→

secondary · POSTED

A biomarker reduction was any decrease from baseline in ctDNA and/or serum tumor antigen levels (CA19-9 or CEA).

All enrolled subject by biomarker type at baseline

→

secondary · POSTED

Biomarker clearance was defined as no detectable ctDNA, CA19-9, or CEA at post-treatment time points

Source null

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id: NCT04853017
trial label: A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors
applicability: unclear
applicability note: Attached because the study's own record names KRAS. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 5
harms Count: 5
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT04853017
outcome key
om-0000
source section id
NCT04853017-om-0000
source outcome index
0
endpoint
The Participant Incidence of Treatment-emergent Adverse Events Considered by the Investigator as Related to ELI-002
endpoint definition
The safety of ELI-002 was monitored through adverse events, including those considered related to treatment by the investigator
time origin
Adverse events were collected through 28 days after the last dose
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All enrolled subjects were included in the analysis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT04853017
outcome key
om-0001
source section id
NCT04853017-om-0001
source outcome index
1
endpoint
The Proportion of Participants With Biomarker Reduction
endpoint definition
A biomarker reduction was any decrease from baseline in circulating tumor DNA (ctDNA) and/or serum tumor antigen levels (carbohydrate antigen 19-9 \[CA19-9\] or carcinoembryonic antigen \[CEA\]).
time origin
6 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT04853017
outcome key
om-0002
source section id
NCT04853017-om-0002
source outcome index
2
endpoint
The Proportion of Participants With Biomarker Clearance
endpoint definition
Biomarker clearance was defined as no detectable ctDNA, CA19-9, or CEA at post-treatment time points.
time origin
6 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT04853017
outcome key
om-0003
source section id
NCT04853017-om-0003
source outcome index
3
endpoint
The Proportion of Participants With Biomarker Reduction by Biomarker Type
endpoint definition
A biomarker reduction was any decrease from baseline in ctDNA and/or serum tumor antigen levels (CA19-9 or CEA).
time origin
6 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All enrolled subject by biomarker type at baseline
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT04853017
outcome key
om-0004
source section id
NCT04853017-om-0004
source outcome index
4
endpoint
The Proportion of Participants With Biomarker Clearance by Biomarker Type
endpoint definition
Biomarker clearance was defined as no detectable ctDNA, CA19-9, or CEA at post-treatment time points
time origin
6 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT04853017
outcome key
om-0000
arm key
OG000
arm label
ELI-002 2P Cohort 1
regimen
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 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)
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04853017-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT04853017
outcome key
om-0000
arm key
OG001
arm label
ELI-002 2P Cohort 2
regimen
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 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)
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04853017-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT04853017
outcome key
om-0000
arm key
OG002
arm label
ELI-002 2P Cohort 3
regimen
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 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)
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04853017-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT04853017
outcome key
om-0000
arm key
OG003
arm label
ELI-002 2P Cohort 4
regimen
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 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)
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04853017-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT04853017
outcome key
om-0000
arm key
OG004
arm label
ELI-002 2P Cohort 5
regimen
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) ELI-002 2P: 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)
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04853017-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT04853017
outcome key
om-0001
arm key
OG000
arm label
ELI-002 2P Cohort 1
regimen
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 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)
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04853017-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT04853017
outcome key
om-0001
arm key
OG001
arm label
ELI-002 2P Cohort 2
regimen
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 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)
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04853017-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT04853017
outcome key
om-0001
arm key
OG002
arm label
ELI-002 2P Cohort 3
regimen
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 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)
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04853017-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT04853017
outcome key
om-0001
arm key
OG003
arm label
ELI-002 2P Cohort 4
regimen
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 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)
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04853017-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT04853017
outcome key
om-0001
arm key
OG004
arm label
ELI-002 2P Cohort 5
regimen
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) ELI-002 2P: 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)
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04853017-om-0001#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT04853017
outcome key
om-0002
arm key
OG000
arm label
ELI-002 2P Cohort 1
regimen
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 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)
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04853017-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT04853017
outcome key
om-0002
arm key
OG001
arm label
ELI-002 2P Cohort 2
regimen
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 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)
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04853017-om-0002#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT04853017
harm key
EG000
source section id
NCT04853017-ae
event group key
EG000
event group label
ELI-002 2P Cohort 1
serious affected
1
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT04853017
harm key
EG001
source section id
NCT04853017-ae
event group key
EG001
event group label
ELI-002 2P Cohort 2
serious affected
0
serious at risk
6
other affected
5
other at risk
6
frequency threshold
0
collection period
For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT04853017
harm key
EG002
source section id
NCT04853017-ae
event group key
EG002
event group label
ELI-002 2P Cohort 3
serious affected
0
serious at risk
5
other affected
4
other at risk
5
frequency threshold
0
collection period
For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT04853017
harm key
EG003
source section id
NCT04853017-ae
event group key
EG003
event group label
ELI-002 2P Cohort 4
serious affected
0
serious at risk
5
other affected
4
other at risk
5
frequency threshold
0
collection period
For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-lumakras-1056c141
nct id
NCT04853017
harm key
EG004
source section id
NCT04853017-ae
event group key
EG004
event group label
ELI-002 2P Cohort 5
serious affected
1
serious at risk
6
other affected
5
other at risk
6
frequency threshold
0
collection period
For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice