drugset / Trial / NCT02485119
Phase I Dose Escalation Study of BAY94-9343 Given by Intravenous Infusion Every 3 Weeks in Japanese Subjects With Advanced Malignancies
NaSingle-groupOpen-labelTreatment
Summary
The primary objectives of the Phase I study 15404 are to evaluate the safety, tolerability and pharmacokinetics of BAY94-9343 given once every 3 weeks in Japanese subjects with advanced, refractory solid tumors. The secondary objectives are to investigate the efficacy, biomarkers and immunogenicity.
Timeline
- Start
- 2015-08-14
- Primary completion
- 2017-04-28
- Completion
- 2017-07-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Anetumab Ravtansine | Monoclonal antibody | 4.5 mg/kg | Intravenous |
| Subject | Anetumab Ravtansine | Monoclonal antibody | 6.5 mg/kg | Intravenous |