Trial Outcomes & Findings for CyPep-1 Injections in Cancer Inducing Lymphocyte Infiltrate Accumulations (NCT NCT04260529)

NCT ID: NCT04260529

Last Updated: 2026-01-29

Results Overview

According to National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) criteria v5.0, and additional safety parameters.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 60 participants
• Primary outcome timeframe: From Informed Consent Form (ICF) signing until Follow Up (FU) or until End of Treatment (EoT) visit. After FU visit, only ongoing AEs or Serious Adverse Events (SAEs) related to CyPep-1 were collected. Duration: up to a maximum of 28 months.
• Results posted on: 2026-01-29

Participant Flow

Participant milestones

Measure	Phase I Cohort 1 0,5 mg/mL CyPep-1 (max 4mL) every 2 weeks (Q2W)	Phase I Cohort 2 2 mg/mL CyPep-1 (max 4mL) Q2W	Phase I Cohort 3 5 mg/mL CyPep-1 (max 4mL) Q2W	Phase IIa Arm A 5 mg/mL CyPep-1 (max 4mL) Q2W, monotherapy	Phase IIa Arm B 5 mg/mL CyPep-1 (max 4mL) Q2W in combination with pembrolizumab 600mg every 6 weeks (Q6W)	Phase IIa Arm C Cohort 4 2 mg/mL CyPep-1 (max 4mL) Q2W for liver metastases	Phase IIa Arm C Cohort 5 5 mg/mL CyPep-1 (max 4mL) Q2W for liver metastases	Phase IIa Arm D 5 mg/mL CyPep-1 (max 4mL) every week for 16 weeks for melanoma
Overall Study STARTED	3	5	6	18	15	6	6	1
Overall Study COMPLETED	3	5	6	18	15	6	6	1
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Phase I Cohort 1 n=3 Participants 0,5 mg/mL CyPep-1 (max 4mL) every 2 weeks (Q2W)	Phase I Cohort 2 n=5 Participants 2 mg/mL CyPep-1 (max 4mL) Q2W	Phase I Cohort 3 n=6 Participants 5 mg/mL CyPep-1 (max 4mL) Q2W	Phase IIa Arm A n=18 Participants 5 mg/mL CyPep-1 (max 4mL) Q2W, monotherapy	Phase IIa Arm B n=15 Participants 5 mg/mL CyPep-1 (max 4mL) Q2W in combination with pembrolizumab 600mg every 6 weeks (Q6W)	Phase IIa Arm C Cohort 4 n=6 Participants 2 mg/mL CyPep-1 (max 4mL) Q2W for liver metastases	Phase IIa Arm C Cohort 5 n=6 Participants 5 mg/mL CyPep-1 (max 4mL) Q2W for liver metastases	Phase IIa Arm D n=1 Participants 5 mg/mL CyPep-1 weekly for 16 weeks for melanoma	Total n=60 Participants Total of all reporting groups
Sex: Female, Male Male	2 Participants n=3 Participants	3 Participants n=5 Participants	4 Participants n=6 Participants	7 Participants n=18 Participants	8 Participants n=15 Participants	2 Participants n=6 Participants	3 Participants n=6 Participants	1 Participants n=1 Participants	30 Participants n=60 Participants
Race and Ethnicity Not Collected	—	—	—	—	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
ECOG Grade 0	0 Participants n=3 Participants	1 Participants n=5 Participants	2 Participants n=6 Participants	6 Participants n=18 Participants	4 Participants n=15 Participants	3 Participants n=6 Participants	2 Participants n=6 Participants	0 Participants n=1 Participants	18 Participants n=60 Participants
Age, Continuous	57.3 years STANDARD_DEVIATION 11.2 • n=3 Participants	64.6 years STANDARD_DEVIATION 10.8 • n=5 Participants	57.7 years STANDARD_DEVIATION 5.9 • n=6 Participants	57.9 years STANDARD_DEVIATION 11.9 • n=18 Participants	63.3 years STANDARD_DEVIATION 8.4 • n=15 Participants	64.0 years STANDARD_DEVIATION 8.8 • n=6 Participants	59.5 years STANDARD_DEVIATION 13.7 • n=6 Participants	55 years STANDARD_DEVIATION 0 • n=1 Participants	60.5 years STANDARD_DEVIATION 10.2 • n=60 Participants
Sex: Female, Male Female	1 Participants n=3 Participants	2 Participants n=5 Participants	2 Participants n=6 Participants	11 Participants n=18 Participants	7 Participants n=15 Participants	4 Participants n=6 Participants	3 Participants n=6 Participants	0 Participants n=1 Participants	30 Participants n=60 Participants
ECOG Grade 1	3 Participants n=3 Participants	4 Participants n=5 Participants	4 Participants n=6 Participants	12 Participants n=18 Participants	11 Participants n=15 Participants	3 Participants n=6 Participants	4 Participants n=6 Participants	1 Participants n=1 Participants	42 Participants n=60 Participants

PRIMARY outcome

Timeframe: From Informed Consent Form (ICF) signing until Follow Up (FU) or until End of Treatment (EoT) visit. After FU visit, only ongoing AEs or Serious Adverse Events (SAEs) related to CyPep-1 were collected. Duration: up to a maximum of 28 months.

According to National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) criteria v5.0, and additional safety parameters.

Outcome measures

Measure	Phase I Cohort 1 n=3 Participants 0.5 mg/mL CyPep-1 (max 4 mL) every 2 weeks (Q2W)	Phase I Cohort 2 n=5 Participants 2 mg/mL CyPep-1 (max 4 mL) Q2W	Phase I Cohort 3 n=6 Participants 5 mg/mL CyPep-1 (max 4 mL) Q2W	Phase IIa Arm A n=18 Participants 5 mg/mL CyPep-1 (max 4 mL) Q2W, monotherapy	Phase IIa Arm B n=15 Participants 5 mg/mL CyPep-1 (max 4 mL) Q2W in combination with pembrolizumab 600mg every 6 weeks (Q6W)	Phase IIa Arm C Cohort 4 n=6 Participants 2 mg/mL CyPep-1 (max 4 mL) Q2W for liver metastases	Phase IIa Arm C Cohort 5 n=6 Participants 5 mg/mL CyPep-1 (max 4 mL) Q2W for liver metastases	Phase IIa Arm D n=1 Participants 5 mg/mL CyPep-1 (max 4 mL) weekly for 16 weeks for melanoma
Type and Number of Adverse Events (AEs) Treatment limiting toxicity	0 number of events	0 number of events	0 number of events	0 number of events	0 number of events	0 number of events	0 number of events	0 number of events
Type and Number of Adverse Events (AEs) Fatal TEAE	0 number of events	0 number of events	0 number of events	0 number of events	0 number of events	0 number of events	1 number of events	0 number of events
Type and Number of Adverse Events (AEs) Treatment Emergent Adverse Event (TEAE)	24 number of events	37 number of events	62 number of events	143 number of events	262 number of events	91 number of events	91 number of events	4 number of events
Type and Number of Adverse Events (AEs) TESAE	1 number of events	0 number of events	0 number of events	3 number of events	7 number of events	1 number of events	3 number of events	0 number of events
Type and Number of Adverse Events (AEs) CTCAE Grade >= 3	9 number of events	4 number of events	5 number of events	8 number of events	12 number of events	4 number of events	12 number of events	0 number of events
Type and Number of Adverse Events (AEs) TEAE leading to Study Treatment discontinuation	0 number of events	0 number of events	1 number of events	1 number of events	0 number of events	0 number of events	0 number of events	0 number of events
Type and Number of Adverse Events (AEs) TEAE leading to CyPep-1 interruption	1 number of events	1 number of events	1 number of events	10 number of events	8 number of events	1 number of events	2 number of events	0 number of events
Type and Number of Adverse Events (AEs) TEAE leading to pembrolizumab interruption	0 number of events	0 number of events	0 number of events	0 number of events	5 number of events	0 number of events	0 number of events	0 number of events
Type and Number of Adverse Events (AEs) Dose limiting toxicity	0 number of events	0 number of events	0 number of events	0 number of events	0 number of events	0 number of events	2 number of events	0 number of events

SECONDARY outcome

Timeframe: up to approximately 28 months

28 days after the date of the initial response, defined by complete response (disappearance of all target lesions) and partial responses (>=30% decrease in the sum of the longest diameter of target lesions), according to Immune Response Evaluation Criteria in Solid Tumors (iRECIST).

Outcome measures

Measure	Phase I Cohort 1 n=3 Participants 0.5 mg/mL CyPep-1 (max 4 mL) every 2 weeks (Q2W)	Phase I Cohort 2 n=5 Participants 2 mg/mL CyPep-1 (max 4 mL) Q2W	Phase I Cohort 3 n=6 Participants 5 mg/mL CyPep-1 (max 4 mL) Q2W	Phase IIa Arm A n=18 Participants 5 mg/mL CyPep-1 (max 4 mL) Q2W, monotherapy	Phase IIa Arm B n=15 Participants 5 mg/mL CyPep-1 (max 4 mL) Q2W in combination with pembrolizumab 600mg every 6 weeks (Q6W)	Phase IIa Arm C Cohort 4 n=6 Participants 2 mg/mL CyPep-1 (max 4 mL) Q2W for liver metastases	Phase IIa Arm C Cohort 5 n=6 Participants 5 mg/mL CyPep-1 (max 4 mL) Q2W for liver metastases	Phase IIa Arm D n=1 Participants 5 mg/mL CyPep-1 (max 4 mL) weekly for 16 weeks for melanoma
Objective Response Rate (ORR)	0.0 percentage of subjects with BOR iCR/iPR Interval 0.0 to 70.8	0.0 percentage of subjects with BOR iCR/iPR Interval 0.0 to 52.2	0.0 percentage of subjects with BOR iCR/iPR Interval 0.0 to 45.9	0.0 percentage of subjects with BOR iCR/iPR Interval 0.0 to 18.5	0.0 percentage of subjects with BOR iCR/iPR Interval 0.0 to 21.8	16.7 percentage of subjects with BOR iCR/iPR Interval 0.4 to 64.1	0.0 percentage of subjects with BOR iCR/iPR Interval 0.0 to 45.9	0.0 percentage of subjects with BOR iCR/iPR Interval 0.0 to 97.5

OTHER_PRE_SPECIFIED outcome

Timeframe: time from treatment start until disease relapse or disease progression (based on all lesions, using iRECIST) or death due to any cause, whichever occurred earliest (up to a maximum of 28 months)

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as increase in the sum of diameters of target lesion(s) identified at baseline to >20% and >5 mm from nadir; unequivocal progression of non-target lesion(s) identified at baseline; and development of new lesion(s).

Outcome measures

Measure	Phase I Cohort 1 n=3 Participants 0.5 mg/mL CyPep-1 (max 4 mL) every 2 weeks (Q2W)	Phase I Cohort 2 n=5 Participants 2 mg/mL CyPep-1 (max 4 mL) Q2W	Phase I Cohort 3 n=6 Participants 5 mg/mL CyPep-1 (max 4 mL) Q2W	Phase IIa Arm A n=18 Participants 5 mg/mL CyPep-1 (max 4 mL) Q2W, monotherapy	Phase IIa Arm B n=15 Participants 5 mg/mL CyPep-1 (max 4 mL) Q2W in combination with pembrolizumab 600mg every 6 weeks (Q6W)	Phase IIa Arm C Cohort 4 n=6 Participants 2 mg/mL CyPep-1 (max 4 mL) Q2W for liver metastases	Phase IIa Arm C Cohort 5 n=6 Participants 5 mg/mL CyPep-1 (max 4 mL) Q2W for liver metastases	Phase IIa Arm D n=1 Participants 5 mg/mL CyPep-1 (max 4 mL) weekly for 16 weeks for melanoma
Progression-free Survival (PFS)	1.6 Months Interval 1.2 to 1.9	1.4 Months Interval 0.0 to 9.3	2.8 Months Interval 1.6 to 12.3	1.8 Months Interval 0.0 to 5.4	1.9 Months Interval 0.6 to 12.9	2.1 Months Interval 1.4 to 5.7	1.9 Months Interval 1.8 to 16.6	0.0 Months Interval 0.0 to 0.0

OTHER_PRE_SPECIFIED outcome

Timeframe: from start of study treatment to the date of death with a maximum of 28 months

Outcome measures

Measure	Phase I Cohort 1 n=3 Participants 0.5 mg/mL CyPep-1 (max 4 mL) every 2 weeks (Q2W)	Phase I Cohort 2 n=5 Participants 2 mg/mL CyPep-1 (max 4 mL) Q2W	Phase I Cohort 3 n=6 Participants 5 mg/mL CyPep-1 (max 4 mL) Q2W	Phase IIa Arm A n=18 Participants 5 mg/mL CyPep-1 (max 4 mL) Q2W, monotherapy	Phase IIa Arm B n=12 Participants 5 mg/mL CyPep-1 (max 4 mL) Q2W in combination with pembrolizumab 600mg every 6 weeks (Q6W)	Phase IIa Arm C Cohort 4 n=6 Participants 2 mg/mL CyPep-1 (max 4 mL) Q2W for liver metastases	Phase IIa Arm C Cohort 5 n=6 Participants 5 mg/mL CyPep-1 (max 4 mL) Q2W for liver metastases	Phase IIa Arm D n=1 Participants 5 mg/mL CyPep-1 (max 4 mL) weekly for 16 weeks for melanoma
Overall Survival (OS)	5.2 Months Interval 2.1 to 21.9	5.5 Months Interval 0.6 to 16.6	13.2 Months Interval 5.3 to 19.8	7.7 Months Interval 1.0 to 26.2	5.8 Months Interval 1.5 to 26.7	8.3 Months Interval 3.3 to 26.3	4.2 Months Interval 2.5 to 17.6	0.7 Months Interval 0.0 to 0.7

Adverse Events

Phase I Cohort 1

Serious events: 1 serious events

Other events: 3 other events

Deaths: 3 deaths

Phase I Cohort 2

Serious events: 0 serious events

Other events: 5 other events

Deaths: 4 deaths

Phase I Cohort 3

Serious events: 0 serious events

Other events: 6 other events

Deaths: 6 deaths

Phase IIa Arm A

Serious events: 3 serious events

Other events: 18 other events

Deaths: 13 deaths

Phase IIa Arm B

Serious events: 2 serious events

Other events: 15 other events

Deaths: 14 deaths

Phase IIa Arm C Cohort 4

Serious events: 1 serious events

Other events: 6 other events

Deaths: 5 deaths

Phase IIa Arm C Cohort 5

Serious events: 2 serious events

Other events: 6 other events

Deaths: 5 deaths

Phase IIa Arm D

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Phase I Cohort 1 n=3 participants at risk 0.5 mg/mL CyPep-1 (max 4 mL) Q2W	Phase I Cohort 2 n=5 participants at risk 2 mg/mL CyPep-1 (max 4 mL) Q2W	Phase I Cohort 3 n=6 participants at risk 5 mg/mL CyPep-1 (max 4 mL) Q2W	Phase IIa Arm A n=18 participants at risk 5 mg/mL CyPep-1 (max 4 mL) Q2W, monotherapy	Phase IIa Arm B n=15 participants at risk 5 mg/mL CyPep-1 (max 4 mL) Q2W in combination with pembrolizumab 600 mg Q6W	Phase IIa Arm C Cohort 4 n=6 participants at risk 2 mg/mL CyPep-1 (max 4 mL) Q2W for liver metastases	Phase IIa Arm C Cohort 5 n=6 participants at risk 5 mg/mL CyPep-1 (max 4 mL) Q2W for liver metastases	Phase IIa Arm D n=1 participants at risk 5 mg/mL CyPep-1 (max 4 mL) weekly for 16 weeks for melanoma
General disorders Injection site reaction	0.00% 0/3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/5 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	11.1% 2/18 • Number of events 2 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	6.7% 1/15 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
General disorders Face oedema	0.00% 0/3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/5 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/18 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	6.7% 1/15 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
Infections and infestations Pneumonia	0.00% 0/3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/5 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/18 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/15 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	16.7% 1/6 • Number of events 2 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
Endocrine disorders Adrenal insufficiency	0.00% 0/3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/5 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/18 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/15 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	16.7% 1/6 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/5 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/18 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	6.7% 1/15 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/5 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	5.6% 1/18 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/15 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
Metabolism and nutrition disorders Malnutrition	0.00% 0/3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/5 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/18 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	6.7% 1/15 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
Vascular disorders Brachiocephalic vein thrombosis	0.00% 0/3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/5 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/18 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	6.7% 1/15 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
Respiratory, thoracic and mediastinal disorders Dyspnoea	33.3% 1/3 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/5 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/18 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/15 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/5 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/18 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/15 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	16.7% 1/6 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
General disorders Fatigue	0.00% 0/3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/5 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/18 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	6.7% 1/15 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
Product Issues Device dislocation	0.00% 0/3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/5 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/18 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	6.7% 1/15 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.

Other adverse events

Measure	Phase I Cohort 1 n=3 participants at risk 0.5 mg/mL CyPep-1 (max 4 mL) Q2W	Phase I Cohort 2 n=5 participants at risk 2 mg/mL CyPep-1 (max 4 mL) Q2W	Phase I Cohort 3 n=6 participants at risk 5 mg/mL CyPep-1 (max 4 mL) Q2W	Phase IIa Arm A n=18 participants at risk 5 mg/mL CyPep-1 (max 4 mL) Q2W, monotherapy	Phase IIa Arm B n=15 participants at risk 5 mg/mL CyPep-1 (max 4 mL) Q2W in combination with pembrolizumab 600 mg Q6W	Phase IIa Arm C Cohort 4 n=6 participants at risk 2 mg/mL CyPep-1 (max 4 mL) Q2W for liver metastases	Phase IIa Arm C Cohort 5 n=6 participants at risk 5 mg/mL CyPep-1 (max 4 mL) Q2W for liver metastases	Phase IIa Arm D n=1 participants at risk 5 mg/mL CyPep-1 (max 4 mL) weekly for 16 weeks for melanoma
Gastrointestinal disorders Vomiting	0.00% 0/3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	40.0% 2/5 • Number of events 2 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	5.6% 1/18 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	26.7% 4/15 • Number of events 5 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	50.0% 3/6 • Number of events 8 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
General disorders Injection site reaction	33.3% 1/3 • Number of events 2 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	80.0% 4/5 • Number of events 6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	100.0% 6/6 • Number of events 23 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	83.3% 15/18 • Number of events 58 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	80.0% 12/15 • Number of events 71 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	83.3% 5/6 • Number of events 15 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	83.3% 5/6 • Number of events 26 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	100.0% 1/1 • Number of events 2 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
General disorders Fatigue	0.00% 0/3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	60.0% 3/5 • Number of events 3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	50.0% 3/6 • Number of events 5 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	50.0% 9/18 • Number of events 13 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	53.3% 8/15 • Number of events 15 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	33.3% 2/6 • Number of events 5 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	83.3% 5/6 • Number of events 6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	100.0% 1/1 • Number of events 2 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
General disorders Pyrexia	33.3% 1/3 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/5 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	11.1% 2/18 • Number of events 2 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	6.7% 1/15 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	50.0% 3/6 • Number of events 4 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	50.0% 3/6 • Number of events 4 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
Infections and infestations COVID-19	0.00% 0/3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/5 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	16.7% 3/18 • Number of events 3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	13.3% 2/15 • Number of events 2 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	16.7% 1/6 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
Infections and infestations Nasopharyngitis	0.00% 0/3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/5 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/18 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	20.0% 3/15 • Number of events 3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	16.7% 1/6 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
Infections and infestations Urinary tract infection	0.00% 0/3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	20.0% 1/5 • Number of events 2 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	5.6% 1/18 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	6.7% 1/15 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	40.0% 2/5 • Number of events 4 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	33.3% 2/6 • Number of events 14 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	27.8% 5/18 • Number of events 8 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	46.7% 7/15 • Number of events 11 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	40.0% 2/5 • Number of events 2 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	33.3% 2/6 • Number of events 3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	27.8% 5/18 • Number of events 5 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	33.3% 5/15 • Number of events 6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	33.3% 2/6 • Number of events 2 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	50.0% 3/6 • Number of events 3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
Metabolism and nutrition disorders Decrease appetite	33.3% 1/3 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/5 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	22.2% 4/18 • Number of events 5 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	26.7% 4/15 • Number of events 7 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	33.3% 2/6 • Number of events 4 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	33.3% 2/6 • Number of events 2 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/5 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/18 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	6.7% 1/15 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	33.3% 2/6 • Number of events 3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	33.3% 2/6 • Number of events 3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/5 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	5.6% 1/18 • Number of events 3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	13.3% 2/15 • Number of events 2 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
Nervous system disorders Dizziness	0.00% 0/3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/5 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	5.6% 1/18 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	13.3% 2/15 • Number of events 2 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	16.7% 1/6 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
Vascular disorders Hypotension	0.00% 0/3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/5 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/18 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	6.7% 1/15 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	16.7% 1/6 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	16.7% 1/6 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
Respiratory, thoracic and mediastinal disorders Dyspnoea	33.3% 1/3 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	20.0% 1/5 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	16.7% 1/6 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	5.6% 1/18 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	6.7% 1/15 • Number of events 5 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	33.3% 2/6 • Number of events 2 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	33.3% 2/6 • Number of events 5 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	20.0% 1/5 • Number of events 2 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	5.6% 1/18 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	6.7% 1/15 • Number of events 2 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	16.7% 1/6 • Number of events 4 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
Gastrointestinal disorders Nausea	0.00% 0/3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	20.0% 1/5 • Number of events 2 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	11.1% 2/18 • Number of events 2 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	33.3% 5/15 • Number of events 9 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	33.3% 2/6 • Number of events 8 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/5 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	11.1% 2/18 • Number of events 3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	13.3% 2/15 • Number of events 4 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	16.7% 1/6 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	16.7% 1/6 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	20.0% 1/5 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	5.6% 1/18 • Number of events 3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	6.7% 1/15 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	16.7% 1/6 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	20.0% 1/5 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/18 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	6.7% 1/15 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/5 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/18 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	40.0% 6/15 • Number of events 6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	16.7% 1/6 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	33.3% 2/6 • Number of events 3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/5 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	16.7% 1/6 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/18 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	6.7% 1/15 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	16.7% 1/6 • Number of events 3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/5 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	5.6% 1/18 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	6.7% 1/15 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	16.7% 1/6 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
General disorders Oedema peripheral	33.3% 1/3 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/5 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/18 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	13.3% 2/15 • Number of events 2 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	16.7% 1/6 • Number of events 2 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
General disorders Influenza like illness	0.00% 0/3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/5 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	16.7% 1/6 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/18 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	6.7% 1/15 • Number of events 4 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	16.7% 1/6 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
General disorders Malaiase	0.00% 0/3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/5 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	5.6% 1/18 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	13.3% 2/15 • Number of events 3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
General disorders Chills	0.00% 0/3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/5 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	5.6% 1/18 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/15 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	16.7% 1/6 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	16.7% 1/6 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
General disorders Injection site haematoma	0.00% 0/3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/5 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	5.6% 1/18 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	13.3% 2/15 • Number of events 2 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
General disorders Pain	0.00% 0/3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	20.0% 1/5 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/18 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	6.7% 1/15 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	16.7% 1/6 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
Investigations Blood alkaline phosphatase increased	33.3% 1/3 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/5 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/18 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	6.7% 1/15 • Number of events 5 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	16.7% 1/6 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
Investigations Lipase increased	0.00% 0/3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/5 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	5.6% 1/18 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	6.7% 1/15 • Number of events 5 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	16.7% 1/6 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
Investigations Gamma-glutamyltransferase increased	33.3% 1/3 • Number of events 2 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/5 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/18 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	6.7% 1/15 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	16.7% 1/6 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
Investigations Alanine aminotransferase increased	33.3% 1/3 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/5 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/18 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	13.3% 2/15 • Number of events 2 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
Investigations Blood creatinine increased	0.00% 0/3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/5 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	5.6% 1/18 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	13.3% 2/15 • Number of events 2 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
Investigations Weight decreased	0.00% 0/3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	20.0% 1/5 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	5.6% 1/18 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	6.7% 1/15 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/5 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/18 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	6.7% 1/15 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	33.3% 2/6 • Number of events 3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	16.7% 1/6 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.
Gastrointestinal disorders Constipation	66.7% 2/3 • Number of events 3 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	20.0% 1/5 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	16.7% 1/6 • Number of events 4 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	5.6% 1/18 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	33.3% 5/15 • Number of events 7 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	50.0% 3/6 • Number of events 6 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	16.7% 1/6 • Number of events 1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.	0.00% 0/1 • Subjects will be monitored for AEs and Events of Clinical Interest (ECIs) from the time of ICF signature until the FU visit (or until EoT, if it occurs more than 30 days after the last CyPep-1 administration). After the FU or EoT visit, only ongoing AEs or SAEs related to CyPep-1 administration will be collected for up to a maximum of 28 months.

Additional Information

CEO

Cytovation ASA

Phone: +4747718809

Email: contact@cytovation.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place