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
AstraZeneca
12 participants
Feb 27, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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 Criteria9
- 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.
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Interventions
radioimmuno-SPECT agent
unconjugated/unlabelled bispecific antibody \[cold\]
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07500987