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

NCT07500987

RecruitingPhase 1

Sponsor: AstraZeneca

Conditions: EGFR Mutation-positive NSCLC

Interventions: [111In]-FPI-2107, FPI-2053

Countries: China

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 overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (3)
  • Beijing, China
  • Shandong, China
  • Wuhan, China