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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Number of Cycles: until progression, unacceptable toxicity or other reasons for withdrawal
Scottsdale Healthcare Hospitals
Scottsdale, Arizona, United States
City of Hope - Comprehensive Cancer Center
Duarte, California, United States
University of California
San Diego, California, United States
UCLA Medical Center
Santa Monica, California, United States
Georgetown University
Washington D.C., District of Columbia, United States
Florida Hospital
Orlando, Florida, United States
Duke Cancer Institute
Durham, North Carolina, United States
Tennessee Oncology
Nashville, Tennessee, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Oncology Consultants
Houston, Texas, United States
Estimate the objective response rate (ORR)
Tumor response will be assessed based on RECIST 1.1 by using CT or MRI
Time frame: 6 months
Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to CTCAE, v4.03.
number of patients with AE/SAE on the base of CTCAE (version 4.03)
Time frame: 15 months
progression free survival (PFS)
PFS according to RECIST 1.1
Time frame: 12 months
duration of response (DOR)
DOR according to RECIST 1.1
Time frame: 9 months
overall survival (OS)
time from the date of first dose of MP0250 until death from any cause or until 1 year for all patients
Time frame: 24 months
time to response (TTR)
TTR according to RECIST 1.1
Time frame: 4 months
Incidence of anti-drug (MP0250) antibody formation
determined as titer of anti-drug antibodies
Time frame: 15 months
pharmacokinetics
half-life
Time frame: 15 months
pharmacokinetics
clearance
Time frame: 15 months
pharmacokinetics
AUC
Time frame: 15 months
pharmacokinetics
Cmax
Time frame: 15 months
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