TheranosticTrials.org

Clinical Trial · NCT07500987

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

Overview

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.

Sponsor

AstraZeneca

Phase

Phase 1

Contacts

AstraZeneca Clinical Study Information Center (CONTACT)

information.center@astrazeneca.com

1-877-240-9479

ClinicalTrials.gov

NCT07500987

Drug / Compound

FPI-2107

Isotope(s):
Target(s):
  • EGFR
Ligand Class: Antibodies

Eligibility

Inclusion

  • 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.
  • * Histologically or cytologically confirmed EGFR mutation positive NSCLC.

Exclusion

  • Clinically relevant proteinuria, or daily urinary protein excretion \> 500 mg).
  • * 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.
  • 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.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (≥ once per month).