Trial Outcomes & Findings for A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors (NCT NCT04853017)

Last Updated: 2025-09-05

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

25 participants

Primary outcome timeframe

Adverse events were collected through 28 days after the last dose

Results posted on

2025-09-05

Participant Flow

Participant milestones

Participant milestones
Measure	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 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: 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)	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)	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)	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)	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)
Overall Study STARTED	3	6	5	5	6
Overall Study COMPLETED	1	2	2	3	3
Overall Study NOT COMPLETED	2	4	3	2	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ELI-002 2P Cohort 1 n=3 Participants 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)	ELI-002 2P Cohort 2 n=6 Participants 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)	ELI-002 2P Cohort 3 n=5 Participants 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)	ELI-002 2P Cohort 4 n=5 Participants 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)	ELI-002 2P Cohort 5 n=6 Participants 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)	Total n=25 Participants Total of all reporting groups
Age, Continuous	50.0 years n=5 Participants	54.5 years n=7 Participants	67.0 years n=5 Participants	67.0 years n=4 Participants	59.0 years n=21 Participants	61.0 years n=8 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	15 Participants n=8 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	5 Participants n=21 Participants	10 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	5 Participants n=21 Participants	21 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants
Region of Enrollment United States	3 participants n=5 Participants	6 participants n=7 Participants	5 participants n=5 Participants	5 participants n=4 Participants	6 participants n=21 Participants	25 participants n=8 Participants
Pancreatic ductal adenocarcinoma diagnosis	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	4 Participants n=4 Participants	6 Participants n=21 Participants	20 Participants n=8 Participants
Disease stage at screening Stage I, II	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	8 Participants n=8 Participants
Disease stage at screening Stage III, IV	2 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	5 Participants n=21 Participants	17 Participants n=8 Participants

PRIMARY outcome

Timeframe: Adverse events were collected through 28 days after the last dose

Population: All enrolled subjects were included in the analysis.

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

Outcome measures

Outcome measures
Measure	ELI-002 2P Cohort 1 n=3 Participants 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)	ELI-002 2P Cohort 2 n=6 Participants 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)	ELI-002 2P Cohort 3 n=5 Participants 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)	ELI-002 2P Cohort 4 n=5 Participants 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)	ELI-002 2P Cohort 5 n=6 Participants 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)
The Participant Incidence of Treatment-emergent Adverse Events Considered by the Investigator as Related to ELI-002	1 Participants	3 Participants	2 Participants	2 Participants	4 Participants

SECONDARY outcome

Timeframe: 6 months

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 \[CEA\]).

Outcome measures

Outcome measures
Measure	ELI-002 2P Cohort 1 n=3 Participants 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)	ELI-002 2P Cohort 2 n=6 Participants 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)	ELI-002 2P Cohort 3 n=5 Participants 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)	ELI-002 2P Cohort 4 n=5 Participants 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)	ELI-002 2P Cohort 5 n=6 Participants 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)
The Proportion of Participants With Biomarker Reduction	2 Participants	5 Participants	4 Participants	4 Participants	6 Participants

SECONDARY outcome

Timeframe: 6 months

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

Outcome measures

Outcome measures
Measure	ELI-002 2P Cohort 1 n=3 Participants 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)	ELI-002 2P Cohort 2 n=6 Participants 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)	ELI-002 2P Cohort 3 n=5 Participants 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)	ELI-002 2P Cohort 4 n=5 Participants 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)	ELI-002 2P Cohort 5 n=6 Participants 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)
The Proportion of Participants With Biomarker Clearance	1 Participants	2 Participants	1 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 6 months

Population: All enrolled subject by biomarker type at baseline

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

Outcome measures

Outcome measures
Measure	ELI-002 2P Cohort 1 n=13 Participants 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)	ELI-002 2P Cohort 2 n=12 Participants 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)	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)	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)	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)
The Proportion of Participants With Biomarker Reduction by Biomarker Type	12 Participants	9 Participants	—	—	—

SECONDARY outcome

Timeframe: 6 months

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

Outcome measures

Outcome measures
Measure	ELI-002 2P Cohort 1 n=13 Participants 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)	ELI-002 2P Cohort 2 n=12 Participants 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)	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)	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)	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)
The Proportion of Participants With Biomarker Clearance by Biomarker Type	6 Participants	0 Participants	—	—	—

Adverse Events

ELI-002 2P Cohort 1

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

ELI-002 2P Cohort 2

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

ELI-002 2P Cohort 3

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

ELI-002 2P Cohort 4

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

ELI-002 2P Cohort 5

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ELI-002 2P Cohort 1 n=3 participants at risk 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)	ELI-002 2P Cohort 2 n=6 participants at risk 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)	ELI-002 2P Cohort 3 n=5 participants at risk 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)	ELI-002 2P Cohort 4 n=5 participants at risk 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)	ELI-002 2P Cohort 5 n=6 participants at risk 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)
Gastrointestinal disorders Abdominal wall haematoma	33.3% 1/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Renal and urinary disorders Nephrolithiasis	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	16.7% 1/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.

Other adverse events

Other adverse events
Measure	ELI-002 2P Cohort 1 n=3 participants at risk 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)	ELI-002 2P Cohort 2 n=6 participants at risk 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)	ELI-002 2P Cohort 3 n=5 participants at risk 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)	ELI-002 2P Cohort 4 n=5 participants at risk 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)	ELI-002 2P Cohort 5 n=6 participants at risk 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)
General disorders Malaise	33.3% 1/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	16.7% 1/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	16.7% 1/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
General disorders Nodule	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	16.7% 1/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Blood and lymphatic system disorders Anaemia	66.7% 2/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	20.0% 1/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	16.7% 1/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Cardiac disorders Sinus bradycardia	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	20.0% 1/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Congenital, familial and genetic disorders Dermoid cyst	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	16.7% 1/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Congenital, familial and genetic disorders Hypermobility syndrome	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	16.7% 1/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Gastrointestinal disorders Abdominal pain	33.3% 1/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	16.7% 1/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	33.3% 2/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Gastrointestinal disorders Anal fissure	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	20.0% 1/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	16.7% 1/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	20.0% 1/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	16.7% 1/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	16.7% 1/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Gastrointestinal disorders Gastric ulcer	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	20.0% 1/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Gastrointestinal disorders Gingival pain	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	16.7% 1/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Gastrointestinal disorders Nausea	33.3% 1/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	20.0% 1/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Gastrointestinal disorders Proctalgia	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	20.0% 1/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
General disorders Catheter site pain	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	16.7% 1/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
General disorders Chills	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	16.7% 1/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
General disorders Fatigue	33.3% 1/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	33.3% 2/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	40.0% 2/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	20.0% 1/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	16.7% 1/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
General disorders Injection site erythema	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	16.7% 1/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
General disorders Injection site induration	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	16.7% 1/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
General disorders Injection site swelling	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	16.7% 1/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
General disorders Localised oedema	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	16.7% 1/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
General disorders Pneumonia cryptococcal	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	16.7% 1/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
General disorders Pyrexia	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	16.7% 1/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Infections and infestations COVID-19	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	20.0% 1/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Infections and infestations Herpes simplex reactivation	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	16.7% 1/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	16.7% 1/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Infections and infestations Urinary tract infection	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	20.0% 1/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	16.7% 1/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Injury, poisoning and procedural complications Contusion	33.3% 1/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Investigations Weight decreased	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	16.7% 1/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	20.0% 1/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	16.7% 1/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Metabolism and nutrition disorders Electrolyte imbalance	33.3% 1/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Metabolism and nutrition disorders Hyperglycaemai	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	40.0% 2/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	40.0% 2/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	33.3% 2/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Metabolism and nutrition disorders Hyperphospataemia	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	20.0% 1/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	16.7% 1/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	16.7% 1/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	20.0% 1/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	16.7% 1/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Musculoskeletal and connective tissue disorders Muscle spasm	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	20.0% 1/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	20.0% 1/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	20.0% 1/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	20.0% 1/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	33.3% 2/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	16.7% 1/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Nervous system disorders Dizziness	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	20.0% 1/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Nervous system disorders Headache	66.7% 2/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	16.7% 1/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	16.7% 1/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	20.0% 1/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	16.7% 1/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Psychiatric disorders Anxiety	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	16.7% 1/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	20.0% 1/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Psychiatric disorders Confusional state	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	20.0% 1/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Psychiatric disorders Insomnia	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	33.3% 2/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Reproductive system and breast disorders Pelvic pain	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	20.0% 1/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	16.7% 1/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	20.0% 1/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	16.7% 1/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	40.0% 2/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	20.0% 1/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	16.7% 1/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	16.7% 1/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	16.7% 1/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	16.7% 1/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	20.0% 1/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Skin and subcutaneous tissue disorders Rash	33.3% 1/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	20.0% 1/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Skin and subcutaneous tissue disorders Sensitive skin	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	16.7% 1/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Vascular disorders Hot flush	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	16.7% 1/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	16.7% 1/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/3 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	20.0% 1/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/5 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.	0.00% 0/6 • For each participant, adverse events were collected through 28 days after the last dose. The last planned dose was at approximately 9 months.

Additional Information

Study Director

Elicio Therapeutics, Inc.

Phone: (857) 209-0050

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place