drugset / Trial / NCT02485119

Phase I Dose Escalation Study of BAY94-9343 Given by Intravenous Infusion Every 3 Weeks in Japanese Subjects With Advanced Malignancies

NCT02485119

Phase 1 Completed 12 enrolled Bayer
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

EvaluationDrugModalityDoseRoute
Subject Anetumab Ravtansine Monoclonal antibody 4.5 mg/kg Intravenous
Subject Anetumab Ravtansine Monoclonal antibody 6.5 mg/kg Intravenous

Indications