drugset / Trial / NCT03123783
CD40 Agonistic Antibody APX005M (Sotigalimab) in Combination With Nivolumab
Non-randomizedSequentialOpen-labelTreatment
Summary
This study is a Phase 1-2 open-label dose escalation study of the immuno-activating monoclonal antibody APX005M administered in combination with nivolumab to adult subjects with non-small cell lung cancer or metastatic melanoma. The Phase 1 portion is intended to establish the maximum tolerated dose and the recommended phase 2 dose of APX005M when administered in combination with nivolumab. The Phase 2 portion of the study will evaluate safety and efficacy of the combination.
Timeline
- Start
- 2017-07-10
- Primary completion
- 2020-11-16
- Completion
- 2020-11-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nivolumab | Monoclonal antibody | 360 mg | Intravenous |
| Subject | sotigalimab | Monoclonal antibody | 0.03 mg/kg | Intravenous |
| Subject | sotigalimab | Monoclonal antibody | 0.1 mg/kg | Intravenous |
| Subject | sotigalimab | Monoclonal antibody | 0.3 mg/kg | Intravenous |