Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05383170 | A Study to Evaluate the Safety and Efficacy of CyPep-1 in Combination With Pembrolizumab for the Treatment of Advanced or Metastatic Cancers | PHASE1 | COMPLETED | 6 | — | — | Mar 21, 2023 | Sep 23, 2024 | Nov 28, 2025 | 25 | United States, France +3 |
Number of CyPep-1 related TEAEs per grading.
Number of DLTs
| Arm | Type | Description |
|---|---|---|
| Arm A: advanced or metastatic HNSCC | EXPERIMENTAL | 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). |
| Arm B: advanced or metastatic melanoma | EXPERIMENTAL | 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). |
| Arm C: advanced or metastatic TNBC | EXPERIMENTAL | 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 TNBC. CyPep-1 will be administered every 2 weeks (Q2W) and pembrolizumab will be administered following a Q6W schedule as per standard of care (SoC). |
| Name | Type | Description |
|---|---|---|
| CyPep-1 | DRUG | Intratumoral injection |
| Pembrolizumab 25 MG/ML [KEYTRUDA®] | DRUG | IV infusion |
Inclusion Criteria: General Inclusion Criteria 1. Is 18 years of age or older on the day of signing informed consent; 2. Provides written informed consent and is able to comply with study procedures and assessments; 3. Has measurable disease as determined by the Response Evaluation Criteria in Sol...