TerminatedPhase 1NCT03418532

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

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.

Checked against the public recordLast updated Mar 23, 2023 · Source: ClinicalTrials.gov

StatusTerminated
PhasePhase 1
U.S. locations10
SponsorMolecular Partners AG
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Molecular Partners AG
Interventions being studied
Combination Product: MP0250 DARPin® drug candidate, Osimertinib
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Scottsdale Healthcare HospitalsScottsdale, Arizona
  • City of Hope - Comprehensive Cancer CenterDuarte, California
  • University of CaliforniaSan Diego, California
  • UCLA Medical CenterSanta Monica, California
  • Georgetown UniversityWashington D.C., District of Columbia
  • Florida HospitalOrlando, Florida
  • Duke Cancer InstituteDurham, North Carolina
  • Tennessee OncologyNashville, Tennessee
  • UT Southwestern Medical CenterDallas, Texas
  • Oncology ConsultantsHouston, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 23, 2023. Always confirm current availability with the study team.

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