drugset / Trial / NCT02412462

Phase I Dose Escalation Study of AB-16B5 in Subjects With an Advanced Solid Malignancy

NCT02412462

Phase 1 Completed 15 enrolled Alethia Biotherapeutics
NaSingle-groupOpen-labelTreatment

Summary

This is a Phase 1 clinical study to investigate the safety, pharmacokinetics and pharmacodynamics of AB-16B5 in patients with an advanced solid malignancy. AB-16B5 is a humanized monoclonal antibody that inhibits the activity of the secreted form of clusterin (sCLU), a potent inducer of the epithelial-to-mesenchymal transition (EMT). Eligible subjects will have a disease that has been refractory to prior therapy and is unlikely to benefit from known therapies.

Timeline

Start
2015-04
Primary completion
2017-01
Completion
2017-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Sotevtamab Monoclonal antibody 1.5 mg/kg Intravenous
Subject Sotevtamab Monoclonal antibody 3 mg/kg Intravenous
Subject Sotevtamab Monoclonal antibody 6 mg/kg Intravenous
Subject Sotevtamab Monoclonal antibody 9 mg/kg Intravenous
Subject Sotevtamab Monoclonal antibody 12 mg/kg Intravenous