Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of CyPep-1 in Combination With Pembrolizumab for the Treatment of Advanced or Metastatic Cancers (NCT NCT05383170)

NCT ID: NCT05383170

Last Updated: 2025-11-28

Results Overview

Number of CyPep-1 related TEAEs per grading.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

6 participants

Primary outcome timeframe

For each subject, from the time of signing the ICF until 30 days (90 days for SAEs) after the last dose of study treatment up to a maximum of 18 months.

Results posted on

2025-11-28

Participant Flow

The Phase 2a part of the study was not initiated and the trial was stopped with 6 patients enrolled in Phase 1b and when the Phase 1b portion of the trial had been successfully completed. The decision not to proceed with the Phase 2a part of the trial was taken following a reassessment of target indications for CyPep-1.

Participant milestones

Participant milestones
Measure	Arm A: Advanced or Metastatic HNSCC The safety and tolerability of CyPep-1 in combination with pembrolizumab will be evaluated in a cohort of 30 subjects in total with advanced or metastatic HNSCC. CyPep-1 will be administered every 2 weeks (Q2W) and pembrolizumab will be administered following a Q6W schedule as per standard of care (SoC). CyPep-1: Intratumoral injection Pembrolizumab 25 MG/ML \[KEYTRUDA®\]: IV infusion	Arm B: Advanced or Metastatic Melanoma The safety and tolerability of CyPep-1 in combination with pembrolizumab will be evaluated in a cohort of 30 subjects in total with advanced or metastatic melanoma. CyPep-1 will be administered every 2 weeks (Q2W) and pembrolizumab will be administered following a Q6W schedule as per standard of care (SoC). CyPep-1: Intratumoral injection Pembrolizumab 25 MG/ML \[KEYTRUDA®\]: IV infusion
Overall Study STARTED	1	5
Overall Study COMPLETED	1	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1b n=6 Participants Phase 1b population of the study which consist of the first 6 patients enrolled. According to the SAP, in general, all summaries will be displayed in Total for Phase 1b. By-arm summaries will not be displayed given the small sample size in Phase 1b.
Age, Customized	55.7 years STANDARD_DEVIATION 10.19 • n=6 Participants
Sex: Female, Male Female	4 Participants n=6 Participants
Sex: Female, Male Male	2 Participants n=6 Participants
ECOG 0	5 participants n=6 Participants
ECOG 1	1 participants n=6 Participants

PRIMARY outcome

Timeframe: For each subject, from the time of signing the ICF until 30 days (90 days for SAEs) after the last dose of study treatment up to a maximum of 18 months.

Population: Phase 1b population of the study which consist of the first 6 patients enrolled. According to the SAP, in general, all summaries will be displayed in Total for Phase 1b. By-arm summaries will not be displayed given the small sample size in Phase 1b.

Number of CyPep-1 related TEAEs per grading.

Outcome measures

Outcome measures
Measure	Phase 1b n=6 Participants Phase 1 b population
Frequency, and Seriousness of TEAEs Grade 2 TEAE	19 number of events
Frequency, and Seriousness of TEAEs Grade 3 TEAE	2 number of events
Frequency, and Seriousness of TEAEs Grade 4 TEAE	0 number of events
Frequency, and Seriousness of TEAEs Grade 5 TEAE	0 number of events
Frequency, and Seriousness of TEAEs Grade 1 TEAE	11 number of events

PRIMARY outcome

Timeframe: Initial 6 weeks of treatment.

Number of DLTs

Outcome measures

Outcome measures
Measure	Phase 1b n=6 Participants Phase 1 b population
Incidence of DLTs	1 number of DLTs

SECONDARY outcome

Timeframe: Up to approximately 18 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

Outcome measures
Measure	Phase 1b n=6 Participants Phase 1 b population
PFS Per RECIST v1.1	3.3 Months Interval 1.9 to 12.0

SECONDARY outcome

Timeframe: Up to approximately 18 months

Outcome measures

Outcome measures
Measure	Phase 1b n=6 Participants Phase 1 b population
OS Per RECIST v1.1	13.4 Months Interval 4.8 to 14.9

Adverse Events

Phase 1b

Serious events: 1 serious events

Other events: 6 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Phase 1b n=6 participants at risk Phase 1b population of the study which consist of the first 6 patients enrolled. According to the SAP, in general, all summaries will be displayed in Total for Phase 1b. By-arm summaries will not be displayed given the small sample size in Phase 1b.
Infections and infestations Erysipelas	16.7% 1/6 • Number of events 1 • For each subject, AEs were collected from the time of signing the ICF until 30 days after the last dose of study treatment and for SAEs from the time of signing the ICF until 90 days after the last dose of study treatment up to a maximum of 18 months.

Other adverse events

Other adverse events
Measure	Phase 1b n=6 participants at risk Phase 1b population of the study which consist of the first 6 patients enrolled. According to the SAP, in general, all summaries will be displayed in Total for Phase 1b. By-arm summaries will not be displayed given the small sample size in Phase 1b.
General disorders Injection site pain	16.7% 1/6 • Number of events 16 • For each subject, AEs were collected from the time of signing the ICF until 30 days after the last dose of study treatment and for SAEs from the time of signing the ICF until 90 days after the last dose of study treatment up to a maximum of 18 months.
General disorders Asthenia	33.3% 2/6 • Number of events 2 • For each subject, AEs were collected from the time of signing the ICF until 30 days after the last dose of study treatment and for SAEs from the time of signing the ICF until 90 days after the last dose of study treatment up to a maximum of 18 months.
General disorders Axillary pain	16.7% 1/6 • Number of events 3 • For each subject, AEs were collected from the time of signing the ICF until 30 days after the last dose of study treatment and for SAEs from the time of signing the ICF until 90 days after the last dose of study treatment up to a maximum of 18 months.
General disorders Chills	16.7% 1/6 • Number of events 1 • For each subject, AEs were collected from the time of signing the ICF until 30 days after the last dose of study treatment and for SAEs from the time of signing the ICF until 90 days after the last dose of study treatment up to a maximum of 18 months.
General disorders Inkection site paraesthesia	16.7% 1/6 • Number of events 1 • For each subject, AEs were collected from the time of signing the ICF until 30 days after the last dose of study treatment and for SAEs from the time of signing the ICF until 90 days after the last dose of study treatment up to a maximum of 18 months.
General disorders Malaise	16.7% 1/6 • Number of events 1 • For each subject, AEs were collected from the time of signing the ICF until 30 days after the last dose of study treatment and for SAEs from the time of signing the ICF until 90 days after the last dose of study treatment up to a maximum of 18 months.
Infections and infestations Skin infection	16.7% 1/6 • Number of events 1 • For each subject, AEs were collected from the time of signing the ICF until 30 days after the last dose of study treatment and for SAEs from the time of signing the ICF until 90 days after the last dose of study treatment up to a maximum of 18 months.
Metabolism and nutrition disorders Hyperkalaemia	16.7% 1/6 • Number of events 1 • For each subject, AEs were collected from the time of signing the ICF until 30 days after the last dose of study treatment and for SAEs from the time of signing the ICF until 90 days after the last dose of study treatment up to a maximum of 18 months.
Metabolism and nutrition disorders Hyponatraemia	16.7% 1/6 • Number of events 1 • For each subject, AEs were collected from the time of signing the ICF until 30 days after the last dose of study treatment and for SAEs from the time of signing the ICF until 90 days after the last dose of study treatment up to a maximum of 18 months.
Blood and lymphatic system disorders Leukocytosis	16.7% 1/6 • Number of events 1 • For each subject, AEs were collected from the time of signing the ICF until 30 days after the last dose of study treatment and for SAEs from the time of signing the ICF until 90 days after the last dose of study treatment up to a maximum of 18 months.
Musculoskeletal and connective tissue disorders Myalgia	16.7% 1/6 • Number of events 1 • For each subject, AEs were collected from the time of signing the ICF until 30 days after the last dose of study treatment and for SAEs from the time of signing the ICF until 90 days after the last dose of study treatment up to a maximum of 18 months.
Respiratory, thoracic and mediastinal disorders Cough	16.7% 1/6 • Number of events 1 • For each subject, AEs were collected from the time of signing the ICF until 30 days after the last dose of study treatment and for SAEs from the time of signing the ICF until 90 days after the last dose of study treatment up to a maximum of 18 months.
Skin and subcutaneous tissue disorders Rash	16.7% 1/6 • Number of events 1 • For each subject, AEs were collected from the time of signing the ICF until 30 days after the last dose of study treatment and for SAEs from the time of signing the ICF until 90 days after the last dose of study treatment up to a maximum of 18 months.

Additional Information

CEO

Cytovation ASA

Phone: +4747718809

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place