drugset / Trial / NCT03418532

MP0250 DARPin® Protein Plus Osimertinib in Patients With EGFR-mutated NSCLC

NCT03418532

Phase 1 Terminated 8 enrolled Molecular Partners AG
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

EvaluationDrugModalityDoseRoute
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