Phase I study of [111In]-FPI-2107 in EGFR mutation-positive NSCLC

Inclusion Criteria

• Inclusion Criteria:
• - Histologically or cytologically confirmed EGFR mutation positive NSCLC.
• - Without any ongoing anti-cancer therapy or with stable ongoing anti-cancer therapy.
• - At least one lesion that is present on 18F-FDG PET/CT scan during screening.
• - ECOG performance status of 0 or 1.
• - Anticipated life expectancy ≥ 12 weeks, in the opinion of the Investigator.
• - Able to provide tumour tissue for analysis.
• Exclusion Criteria:
• - Confirmed radiographic disease progression or Investigator-assessed clinical disease progression within 28 days prior to the administration of [111In]-FPI-2107.
• - Contraindications to or inability to perform the imaging procedures required in this study.
• - Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (≥ once per month).
• - History of myocardial infarction or New York Heart Association Class II-IV congestive heart failure within 6 months of the administration of [111In]-FPI-2107, CTCAE Grade 2 or worse conduction defect or uncontrolled hypertension.
• - Clinically relevant proteinuria, or daily urinary protein excretion > 500 mg).
• - Any antibody-based therapy targeting EGFR and/or c-MET, or investigational agent within 28 days or 5 half-lives prior to the administration of [111In]-FPI-2107, whichever is shorter.
• - Any systemic radiopharmaceutical within 28 days or 5 radioactive half-lives prior to the administration of [111In]-FPI-2107, whichever is shorter.
• - Any anticipated need for switching of any concomitant anti-cancer therapy during the imaging period of the study.
• - External beam radiation therapy within 28 days prior to the administration of [111In]-FPI-2107.