drugset / Trial / NCT04205227
ENB003 Plus Pembrolizumab Phase 1b/2a in Solid Tumors
Non-randomizedSingle-groupOpen-labelTreatment
Summary
First-in Human study evaluating the safety, tolerability and efficacy of ENB003 in combination with Pembrolizumab in solid tumors. The study is separated into two parts. Part A is a 3+3 dose escalation to define the recommended RP2D; this part will include metastatic melanoma, platinum resistant ovarian cancer, and pancreatic cancer patients subjects, but other solid tumors will be allowed. Once the RP2D is selected, the study will be expanded into metastatic melanoma, platinum resistant ovarian cancer, and pancreatic cancer subjects. A small number of sarcoma subjects will be included, as exploratory.
Timeline
- Start
- 2020-02-18
- Primary completion
- 2026-01-01
- Completion
- 2026-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ENB003 | Unknown | 150 ug | — |
| Subject | ENB003 | Unknown | 300 ug | — |
| Subject | ENB003 | Unknown | 500 ug | — |
| Subject | ENB003 | Unknown | 750 ug | — |
| Subject | ENB003 | Unknown | 1000 ug | — |
| Subject | ENB003 | Unknown | 2000 ug | — |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | — |