drugset / Trial / NCT03418532
MP0250 DARPin® Protein Plus Osimertinib in Patients With EGFR-mutated NSCLC
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to assess the anti-tumor efficacy, safety, tolerability, pharmacokinetics (PK), immunogenicity and biological activity of the MP0250 DARPin® drug candidate in combination with osimertinib orally once daily (o.d.), when administered to patients with EGFR mutated, advanced, non squamous NSCLC after tumor progression on osimertinib and on or after the most recent therapy. MP0250 is a multi-DARPin® protein with three specificities, able to simultaneously neutralize the activities of vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF) and also to bind to human serum albumin (HSA) to give an increased plasma half-life and potentially enhanced tumor penetration.
Timeline
- Start
- 2018-03-22
- Primary completion
- 2019-08-30
- Completion
- 2020-04-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MP0250 | Protein / enzyme biologic | 6 mg/kg | Other |
| Subject | MP0250 | Protein / enzyme biologic | 8 mg/kg | Other |
| Subject | MP0250 | Protein / enzyme biologic | 12 mg/kg | Other |
| Background | Osimertinib | Small molecule | — | Oral |