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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03418532
Recruitment Status : Active, not recruiting
First Posted : February 1, 2018
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Molecular Partners AG

Brief 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.


Condition or disease Intervention/treatment Phase
EGFR-mutated NSCLC (Disorder) Combination Product: MP0250 DARPin® drug candidate, Osimertinib Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 22, 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Osimertinib

Arm Intervention/treatment
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
Combination Product: MP0250 DARPin® drug candidate, Osimertinib
Number of Cycles: until progression, unacceptable toxicity or other reasons for withdrawal




Primary Outcome Measures :
  1. Estimate the objective response rate (ORR) [ Time Frame: 6 months ]
    Tumor response will be assessed based on RECIST 1.1 by using CT or MRI


Secondary Outcome Measures :
  1. Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to CTCAE, v4.03. [ Time Frame: 15 months ]
    number of patients with AE/SAE on the base of CTCAE (version 4.03)

  2. progression free survival (PFS) [ Time Frame: 12 months ]
    PFS according to RECIST 1.1

  3. duration of response (DOR) [ Time Frame: 9 months ]
    DOR according to RECIST 1.1

  4. overall survival (OS) [ Time Frame: 24 months ]
    time from the date of first dose of MP0250 until death from any cause or until 1 year for all patients

  5. time to response (TTR) [ Time Frame: 4 months ]
    TTR according to RECIST 1.1

  6. Incidence of anti-drug (MP0250) antibody formation [ Time Frame: 15 months ]
    determined as titer of anti-drug antibodies

  7. pharmacokinetics [ Time Frame: 15 months ]
    half-life

  8. pharmacokinetics [ Time Frame: 15 months ]
    clearance

  9. pharmacokinetics [ Time Frame: 15 months ]
    AUC

  10. pharmacokinetics [ Time Frame: 15 months ]
    Cmax


Other Outcome Measures:
  1. biomarkers in tissue [ Time Frame: 12 months ]
    biomarkers associated with response or resistance to MP0250, HGF by IHC

  2. biomarkers in blood [ Time Frame: 12 months ]
    biomarkers associated with response or resistance to MP0250, HGF by ELISA



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed metastatic or unresectable locally advanced non-squamous NSCLC with documented EGFR mutation-positive disease
  2. Radiologically documented disease progression on previous osimertinib treatment.
  3. Radiologically documented disease progression on or after most recent antitumor therapy.
  4. Measurable disease according to RECIST 1.1.
  5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 2.
  6. Men and women ≥18 years old on the day of signing informed consent.
  7. Adequate hematological, hepatic and renal function prior to first dose
  8. Serum albumin concentration ≥30 g/L
  9. Potassium and magnesium within normal range

Exclusion Criteria:

  1. Necrotic tumors or tumors close to large blood vessels that may impose an increased bleeding risk when treated with anti-VEGF agents.
  2. Second malignancy that is currently clinically significant or required active intervention during the period of 12 months prior to Screening, except early stage non-melanoma skin cancer treated with curative intent.
  3. Known pre-existing interstitial or inflammatory lung disease.
  4. Clinical signs of or documented leptomeningeal carcinomatosis. Features such as headache, nuchal rigidity, and photophobia may indicate meningeal involvement.
  5. Known brain metastases who are clinically unstable
  6. Prohibited anti-NSCLC therapies and not having recovered from related AEs to Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤1
  7. Any investigational drug within 28 days prior to study treatment.
  8. Current participation in any other interventional clinical study (except survival follow up).
  9. Neuropathy as residual toxicity after prior antitumor therapy Grade >2
  10. Patients taking medications that have the potential to prolong the QT interval
  11. Significant cardiac abnormalities
  12. Uncontrolled hypertension
  13. Significant risk for bleeding
  14. Active or recent thrombolic events

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03418532


Locations
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United States, Arizona
Scottsdale Healthcare Hospitals
Scottsdale, Arizona, United States, 85258
United States, California
City of Hope - Comprehensive Cancer Center
Duarte, California, United States, 91010
University of California
San Diego, California, United States, 92093
UCLA Medical Center
Santa Monica, California, United States, 90404
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20057
United States, Florida
Florida Hospital
Orlando, Florida, United States, 32803
United States, North Carolina
Duke Cancer Institute
Durham, North Carolina, United States, 27710
United States, Tennessee
Tennessee Oncology
Nashville, Tennessee, United States, 37203
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Oncology Consultants
Houston, Texas, United States, 77030
Sponsors and Collaborators
Molecular Partners AG

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Responsible Party: Molecular Partners AG
ClinicalTrials.gov Identifier: NCT03418532     History of Changes
Other Study ID Numbers: MP0250-CP202
First Posted: February 1, 2018    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Molecular Partners AG:
DARPin®protein
MP0250
VEGF
HGF
NSCLC
EGFR mutated
Osimertinib
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Osimertinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action