NCT03418532

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

A Phase 1b/2, Single-arm, Open-label, Multi-center Study of MP0250 in Combination With Osimertinib in Patients With EGFR-mutated Non-squamous Non-small Cell Lung Cancer (NSCLC) Pretreated With Osimertinib

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Molecular Partners AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• EGFR-mutated NSCLC (Disorder)

Interventions

Type	Name	Description
COMBINATION_PRODUCT	MP0250 DARPin® drug candidate, Osimertinib	Number of Cycles: until progression, unacceptable toxicity or other reasons for withdrawal

Timeline

• Start date: 2018-03-22
• Primary completion: 2019-08-30
• Completion: 2020-04-24
• First posted: 2018-02-01
• Last updated: 2023-03-23

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study