drugset / Trial / NCT02076451
Open-label Study of DS-8273a to Assess Its Safety and Tolerability, and Assess Its Pharmacokinetic and Pharmacodynamic Properties in Subjects With Advanced Solid Tumors or Lymphomas
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This will be a Phase 1, open-label study of DS-8273a to assess its safety and tolerability, identify the Maximum Tolerated Dose and/or Maximum Administered Dose, and assess its properties in subjects with advanced solid tumors or lymphomas. Up to 5 US sites are planned for participation in Part 1 (Dose Escalation) and Part 2 (Dose Expansion) in subjects with solid tumors or lymphomas.
Timeline
- Start
- 2014-02
- Primary completion
- 2015-12
- Completion
- 2015-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DS-8273a | Monoclonal antibody | 2 mg/kg | Intravenous |
| Subject | DS-8273a | Monoclonal antibody | 8 mg/kg | Intravenous |
| Subject | DS-8273a | Monoclonal antibody | 16 mg/kg | Intravenous |
| Subject | DS-8273a | Monoclonal antibody | 24 mg/kg | Intravenous |