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Clinical Trial NCT07500987 for EGFR Mutation-positive NSCLC is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Phase I Study of [111In]-FPI-2107 in EGFR Mutation-positive NSCLC Phase 1 12 Open-Label

Recruiting
Clinical Trial NCT07500987 is designed to study Diagnostic for EGFR Mutation-positive NSCLC. It is a Phase 1 interventional study that is recruiting, having started on 27 February 2026, with plans to enroll 12 participants. Led by AstraZeneca, it is expected to complete by 21 July 2026. The latest data from ClinicalTrials.gov was last updated on 30 March 2026.
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.
Official Title

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

Conditions
EGFR Mutation-positive NSCLC
Other Study IDs
  • D8650C00002
NCT ID Number
NCT07500987
Start Date (Actual)
2026-02-27
Last Update Posted
2026-03-30
Completion Date (Estimated)
2026-07-21
Enrollment (Estimated)
12
Study Type
Interventional
PHASE
Phase 1
Status
Recruiting
Keywords
EGFR mutation-positive NSCLC
[111In]-FPI-2107
FPI-2053
Primary Purpose
Diagnostic
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Experimental[111In]-FPI-2107 and FPI-2053
2 study interventions both based on the same EGFR and c-MET bispecific antibody
[111In]-FPI-2107
radioimmuno-SPECT agent
FPI-2053
unconjugated/unlabelled bispecific antibody \[cold\]
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Safety and tolerability of [111In]-FPI 2107 following the administration of FPI 2053
Safety and tolerability will be evaluated by frequency, duration, and severity of AEs, and changes in clinical, laboratory, and ECG parameters compared to baseline
From the screening period to 21 days after dosing
Dosimetry parameter of [111In]-FPI 2107 following the administration of FPI 2053
Residence time of the segmented source organs
During the Imaging period (Day1 - Day4/5)
Dosimetry parameter of [111In]-FPI 2107 following the administration of FPI 2053
Absorbed radiation doses of all target organs
During the Imaging period (Day1 - Day4/5)
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Tumour uptake of [111In]-FPI-2107
Tumour uptake of \[111In\]-FPI 2107 in selected regions of interest on SPECT/CT and/or planar images
During the Imaging period (Day1 - Day4/5)
PK of [111In]-FPI-2107: Peak Plasma Concentration (Cmax)
Determine the peak plasma concentration of \[111In\]-FPI-2107 following administration of FPI-2053 and \[111In\]-FPI-2107
From the dose of investigation product (Day 1) until Day 4/5
PK of [111In]-FPI-2107: AUClast
Calculate the area under the curve using PK concentrations of \[111In\]-FPI-2107 to determine exposure of the product
From the dose of investigation product (Day 1) until Day 4/5
PK of [111In]-FPI-2107: Clearance
Determine the clearance of \[111In\]-FPI-2107 with the pre-dose administration of FPI-2053 using PK concentrations of \[111In\]-FPI-2107
From the dose of investigation product (Day 1) until Day 4/5
PK of [111In]-FPI-2107: Half-life
Determine the half-life of \[111In\]-FPI-2107 with the pre-dose administration of FPI-2053 using PK concentrations of \[111In\]-FPI-2107
From the dose of investigation product (Day 1) until Day 4/5
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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.

  • 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.
AstraZeneca logoAstraZeneca
Study Central Contact
Contact: AstraZeneca Clinical Study Information Center, 1-877-240-9479, [email protected]
3 Study Locations in 1 Countries
Research Site, Beijing, 100142, China
Recruiting
Research Site, Shandong, China
Recruiting
Research Site, Wuhan, 430022, China
Recruiting