IA Trial Radar | ||
|---|---|---|
El ensayo clínico NCT07500987 para EGFR Mutation-positive NSCLC está reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
Un estudio coincide con los criterios de filtro
Vista de tarjeta
Volver a la búsqueda
AstraZenecaPhase I Study of [111In]-FPI-2107 in EGFR Mutation-positive NSCLC Fase I 12 Etiqueta abierta
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT07500987 está diseñado para estudiar el diagnóstico de EGFR Mutation-positive NSCLC. Es un estudio intervencionista de Fase I. Su estado actual es: reclutando. El estudio se inició el 27 de febrero de 2026, con el objetivo de reclutar a 12 participantes. Dirigido por AstraZeneca, se espera que finalice el 21 de julio de 2026. Los datos se actualizaron por última vez en ClinicalTrials.gov el 30 de marzo de 2026.
Resumen
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.
Título oficial
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
Condiciones médicas
EGFR Mutation-positive NSCLCOtros ID del estudio
- D8650C00002
Número del NCT
Inicio del estudio (real)
2026-02-27
Última actualización
2026-03-30
Fecha de finalización (estimada)
2026-07-21
Inscripción (prevista)
12
Tipo de estudio
Intervencionista
FASE
Fase I
Estado general
Reclutando
Palabras clave
EGFR mutation-positive NSCLC
[111In]-FPI-2107
FPI-2053
[111In]-FPI-2107
FPI-2053
Objetivo principal
Diagnóstico
Método de asignación
N/A
Modelo de intervención
Grupo único
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
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 \[cold\] |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
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) |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
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 |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
- 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.
AstraZenecaContactos centrales del estudio
Contacto: AstraZeneca Clinical Study Information Center, 1-877-240-9479, [email protected]
3 Centros del estudio en 1 países
Research Site, Beijing, 100142, China
Reclutando
Research Site, Shandong, China
Reclutando
Research Site, Wuhan, 430022, China
Reclutando