Phase I Study of [111In]-FPI-2107 in EGFR Mutation-positive NSCLC

A Phase I Multicentre Open-label Study to Evaluate Safety, Tolerability, and Dosimetry of [111In]-FPI-2107 in Chinese Adult Participants With EGFR Mutation-positive NSCLC

This is a Phase I, multicentre, open-label clinical study designed to investigate the safety, tolerability, dosimetry, biodistribution, PD, and PK of [111In]-FPI-2107 after pre-dose administration of FPI-2053 in Chinese participants with EGFR mutation-positive NSCLC.

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.