EGFR Mutation-positive NSCLC
Conditions
Keywords
EGFR mutation-positive NSCLC, [111In]-FPI-2107, FPI-2053
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.
Interventions
DRUG[111In]-FPI-2107
radioimmuno-SPECT agent
DRUGFPI-2053
unconjugated/unlabelled bispecific antibody \[cold\]
Sponsors
AstraZeneca
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 130 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of [111In]-FPI 2107 following the administration of FPI 2053 | From the screening period to 21 days after dosing | Safety and tolerability will be evaluated by frequency, duration, and severity of AEs, and changes in clinical, laboratory, and ECG parameters compared to baseline |
| Dosimetry parameter of [111In]-FPI 2107 following the administration of FPI 2053 | During the Imaging period (Day1 - Day4/5) | Residence time of the segmented source organs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumour uptake of [111In]-FPI-2107 | During the Imaging period (Day1 - Day4/5) | Tumour uptake of \[111In\]-FPI 2107 in selected regions of interest on SPECT/CT and/or planar images |
| PK of [111In]-FPI-2107: Peak Plasma Concentration (Cmax) | From the dose of investigation product (Day 1) until Day 4/5 | Determine the peak plasma concentration of \[111In\]-FPI-2107 following administration of FPI-2053 and \[111In\]-FPI-2107 |
| PK of [111In]-FPI-2107: AUClast | From the dose of investigation product (Day 1) until Day 4/5 | Calculate the area under the curve using PK concentrations of \[111In\]-FPI-2107 to determine exposure of the product |
| PK of [111In]-FPI-2107: Clearance | From the dose of investigation product (Day 1) until Day 4/5 | Determine the clearance of \[111In\]-FPI-2107 with the pre-dose administration of FPI-2053 using PK concentrations of \[111In\]-FPI-2107 |
| PK of [111In]-FPI-2107: Half-life | From the dose of investigation product (Day 1) until Day 4/5 | Determine the half-life of \[111In\]-FPI-2107 with the pre-dose administration of FPI-2053 using PK concentrations of \[111In\]-FPI-2107 |
Countries
China
Outcome results
None listed