Status:
TERMINATED
MP0250 DARPin® Protein Plus Osimertinib in Patients With EGFR-mutated NSCLC
Lead Sponsor:
Molecular Partners AG
Conditions:
EGFR-mutated NSCLC (Disorder)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- Histologically confirmed metastatic or unresectable locally advanced non-squamous NSCLC with documented EGFR mutation-positive disease
- Radiologically documented disease progression on previous osimertinib treatment.
- Radiologically documented disease progression on or after most recent antitumor therapy.
- Measurable disease according to RECIST 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 2.
- Men and women ≥18 years old on the day of signing informed consent.
- Adequate hematological, hepatic and renal function prior to first dose
- Serum albumin concentration ≥30 g/L
- Potassium and magnesium within normal range
Exclusion
- Necrotic tumors or tumors close to large blood vessels that may impose an increased bleeding risk when treated with anti-VEGF agents.
- 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.
- Known pre-existing interstitial or inflammatory lung disease.
- Clinical signs of or documented leptomeningeal carcinomatosis. Features such as headache, nuchal rigidity, and photophobia may indicate meningeal involvement.
- Known brain metastases who are clinically unstable
- Prohibited anti-NSCLC therapies and not having recovered from related AEs to Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤1
- Any investigational drug within 28 days prior to study treatment.
- Current participation in any other interventional clinical study (except survival follow up).
- Neuropathy as residual toxicity after prior antitumor therapy Grade \>2
- Patients taking medications that have the potential to prolong the QT interval
- Significant cardiac abnormalities
- Uncontrolled hypertension
- Significant risk for bleeding
- Active or recent thrombolic events
Key Trial Info
Start Date :
March 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2020
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03418532
Start Date
March 22 2018
End Date
April 24 2020
Last Update
March 23 2023
Active Locations (10)
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1
Scottsdale Healthcare Hospitals
Scottsdale, Arizona, United States, 85258
2
City of Hope - Comprehensive Cancer Center
Duarte, California, United States, 91010
3
University of California
San Diego, California, United States, 92093
4
UCLA Medical Center
Santa Monica, California, United States, 90404