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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 : Terminated (Sponsor's decision)
First Posted : February 1, 2018
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
Molecular Partners AG

Tracking Information
First Submitted Date  ICMJE January 10, 2018
First Posted Date  ICMJE February 1, 2018
Last Update Posted Date May 29, 2020
Actual Study Start Date  ICMJE March 22, 2018
Actual Primary Completion Date August 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2018)
  • 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)
  • progression free survival (PFS) [ Time Frame: 12 months ]
    PFS according to RECIST 1.1
  • duration of response (DOR) [ Time Frame: 9 months ]
    DOR according to RECIST 1.1
  • 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
  • time to response (TTR) [ Time Frame: 4 months ]
    TTR according to RECIST 1.1
  • Incidence of anti-drug (MP0250) antibody formation [ Time Frame: 15 months ]
    determined as titer of anti-drug antibodies
  • pharmacokinetics [ Time Frame: 15 months ]
    half-life
  • pharmacokinetics [ Time Frame: 15 months ]
    clearance
  • pharmacokinetics [ Time Frame: 15 months ]
    AUC
  • pharmacokinetics [ Time Frame: 15 months ]
    Cmax
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 31, 2018)
  • biomarkers in tissue [ Time Frame: 12 months ]
    biomarkers associated with response or resistance to MP0250, HGF by IHC
  • biomarkers in blood [ Time Frame: 12 months ]
    biomarkers associated with response or resistance to MP0250, HGF by ELISA
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE MP0250 DARPin® Protein Plus Osimertinib in Patients With EGFR-mutated NSCLC
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE EGFR-mutated NSCLC (Disorder)
Intervention  ICMJE Combination Product: MP0250 DARPin® drug candidate, Osimertinib
Number of Cycles: until progression, unacceptable toxicity or other reasons for withdrawal
Study Arms  ICMJE 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
Intervention: Combination Product: MP0250 DARPin® drug candidate, Osimertinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 27, 2020)
8
Original Estimated Enrollment  ICMJE
 (submitted: January 31, 2018)
40
Actual Study Completion Date  ICMJE April 24, 2020
Actual Primary Completion Date August 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03418532
Other Study ID Numbers  ICMJE MP0250-CP202
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Molecular Partners AG
Study Sponsor  ICMJE Molecular Partners AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Molecular Partners AG
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP