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

StatusTerminated
PhasePhase 1
Started

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Record History

  1. Trial terminated Sponsor's reason: Early termination was due to insufficient tumor uptake thought to be limited by the binding affinity of EGFR, The termination is not related to any safety or quality concerns.
    • Final enrollment: 6 participants (planned 12)
    • Primary completion date changed from estimate of Jul 21, 2026 to May 13, 2026
    • Site details revised at 3 of 3 sites
    v5
  2. 3 versions Re-verified since Apr 21, 2026, no change to tracked fieldsv2-v4
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
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.
Trial Details
NCT Number NCT07500987
Lead Sponsor AstraZeneca
Conditions
(from sponsor)		 EGFR Mutation-positive NSCLC
Enrollment 6 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov