drugset / Trial / NCT02412462
Phase I Dose Escalation Study of AB-16B5 in Subjects With an Advanced Solid Malignancy
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |