Early-phase [111In]-FPI-2107 imaging for EGFR mutation–positive non‑small cell lung cancer

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 test tries whether giving a pre-dose of FPI-2053 followed by the imaging agent [111In]-FPI-2107 is safe and shows where tumors are in people with EGFR mutation–positive non‑small cell lung cancer.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years to 130 Years
• Sex: All
• Sponsor: AstraZeneca (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 3 sites (Beijing and 2 other locations)
• Trial ID: NCT07500987 on ClinicalTrials.gov

What this trial studies

This Phase I, multicenter, open-label trial in Chinese adults gives a pre-dose of unlabelled FPI-2053 followed by a radiolabeled microdose of [111In]-FPI-2107 to measure safety, tolerability, biodistribution, dosimetry, pharmacokinetics, and pharmacodynamics. Participants must have histologically or cytologically confirmed EGFR mutation–positive NSCLC, at least one lesion visible on 18F-FDG PET/CT, ECOG 0–1, and be able to provide tumor tissue. Serial imaging and blood sampling will map tracer uptake, quantify radiation exposure to organs, and track how the agent clears from the body. Results will inform safe dosing and imaging parameters for future development.

Who should consider this trial

Good fit: Adults with histologically or cytologically confirmed EGFR mutation–positive NSCLC who have at least one FDG-PET-detectable lesion, ECOG performance status 0–1, anticipated life expectancy ≥12 weeks, and can provide tumor tissue are ideal candidates.

Not a fit: Patients with recent radiographic or clinical progression within 28 days, uncontrolled effusions requiring frequent drainage, recent major cardiac events, inability to undergo required imaging, or without EGFR mutations are unlikely to benefit.

Why it matters

Potential benefit: If successful, this approach could provide a safe imaging tool to locate EGFR-mutant tumors and help guide treatment decisions.

How similar studies have performed: Other early-phase programs of EGFR-targeted radiotracers and predosing strategies have reported promising biodistribution and safety signals, but the specific combination of [111In]-FPI-2107 after FPI-2053 predose is relatively novel and not yet proven.

Eligibility 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.

Where this trial is running

Beijing and 2 other locations

• Research Site — Beijing, China (Recruiting)
• Research Site — Shandong, China (Recruiting)
• Research Site — Wuhan, China (Recruiting)

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center

Conditions EGFR Mutation-positive NSCLC; EGFR mutation-positive NSCLC; [111In]-FPI-2107; FPI-2053