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← Bile Duct Cancer (Cholangiocarcinoma)

NCT04853017 · STUDY IN CONTEXT

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

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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-bile-duct-cancer-cholangiocarcinoma
nct id
NCT04853017
trial label
A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    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
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    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
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    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
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    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
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    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
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    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
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    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
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    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
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    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
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    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
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    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
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    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
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    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
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-bile-duct-cancer-cholangiocarcinoma
    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