NCT04853017 · ADVERSE EVENTS

Adverse events

A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors · Source last updated 2025-09-05

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
ELI-002 2P Cohort 1 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)	1 / 3	3 / 3	0 / 3
ELI-002 2P Cohort 2 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)	0 / 6	5 / 6	0 / 6
ELI-002 2P Cohort 3 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)	0 / 5	4 / 5	0 / 5
ELI-002 2P Cohort 4 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)	0 / 5	4 / 5	0 / 5
ELI-002 2P Cohort 5 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)	1 / 6	5 / 6	0 / 6

Group identifiers: EG000: ELI-002 2P Cohort 1 · EG001: ELI-002 2P Cohort 2 · EG002: ELI-002 2P Cohort 3 · EG003: ELI-002 2P Cohort 4 · EG004: ELI-002 2P Cohort 5

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
6
term
Abdominal wall haematoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
1
num At Risk
6
term
Nephrolithiasis

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
6
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
1
num At Risk
6
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
6
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Congenital, familial and genetic disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
1
num At Risk
6
term
Dermoid cyst
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Congenital, familial and genetic disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
6
term
Hypermobility syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
2
num At Risk
6
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
6
term
Anal fissure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
1
num At Risk
6
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
1
num At Risk
6
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
6
term
Gastric ulcer
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
6
term
Gingival pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
6
term
Nausea

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
3
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 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)
id
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
ELI-002 2P Cohort 1
deaths Num Affected
0
deaths Num At Risk
6
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) 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)
id
EG001
other Num Affected
5
other Num At Risk
6
serious Num Affected
0
serious Num At Risk
6
title
ELI-002 2P Cohort 2
deaths Num Affected
0
deaths Num At Risk
5
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) 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)
id
EG002
other Num Affected
4
other Num At Risk
5
serious Num Affected
0
serious Num At Risk
5
title
ELI-002 2P Cohort 3
deaths Num Affected
0
deaths Num At Risk
5
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) 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)
id
EG003
other Num Affected
4
other Num At Risk
5
serious Num Affected
0
serious Num At Risk
5
title
ELI-002 2P Cohort 4
deaths Num Affected
0
deaths Num At Risk
6
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) 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)
id
EG004
other Num Affected
5
other Num At Risk
6
serious Num Affected
1
serious Num At Risk
6
title
ELI-002 2P Cohort 5

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
6
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
1
num At Risk
6
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
6
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Congenital, familial and genetic disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
1
num At Risk
6
term
Dermoid cyst
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Congenital, familial and genetic disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
6
term
Hypermobility syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
2
num At Risk
6
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
6
term
Anal fissure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
1
num At Risk
6
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
1
num At Risk
6
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
6
term
Gastric ulcer
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
6
term
Gingival pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
1
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
6
term
Nausea

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
0
num At Risk
6
term
Abdominal wall haematoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA (26.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
5
group Id
EG003
num Affected
0
num At Risk
5
group Id
EG004
num Affected
1
num At Risk
6
term
Nephrolithiasis

time Frame

For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.

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