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

Conditions

• EGFR-mutated NSCLC (Disorder)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Mar 22, 2018

Status verified

Mar 2023

Primary completion

Aug 30, 2019

Completion

Apr 24, 2020

Study Design

Enrollment

8 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: single arm
  MP0250 DARPin® drug candidate (6 mg/kg or 8 mg/kg or 12 mg/kg, infusion) on day 1 of each 21 day cycle. Osimertinib according to label

Primary Outcome Measure

Estimate the objective response rate (ORR) [ Time Frame: 6 months ]

Locations (10)

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