NCT07500987 Phase I Study of [111In]-FPI-2107 in EGFR Mutation-positive NSCLC
| NCT ID | NCT07500987 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | AstraZeneca |
| Condition | EGFR Mutation-positive NSCLC |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2026-02-27 |
| Primary Completion | 2026-07-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2026-02-27 with a primary completion date of 2026-07-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07500987 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 130 Years, studying EGFR Mutation-positive NSCLC. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07500987 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07500987 currently recruiting?
Yes, NCT07500987 is actively recruiting participants. Contact the research team at information.center@astrazeneca.com for enrollment information.
Where is the NCT07500987 trial being conducted?
This trial is being conducted at Beijing, China, Shandong, China, Wuhan, China.
Who is sponsoring the NCT07500987 clinical trial?
NCT07500987 is sponsored by AstraZeneca. The trial plans to enroll 12 participants.