Resumen

Elegibilidad

Detalles del diseño

Brazos e Intervenciones

Medidas de resultado

Sitios del ensayo

Fuente: NCT05634954

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Study to Evaluate Safety and Dosimetry of [18F]GEH121224 in Patients With Locally Advanced or Metastatic Breast Cancer

Intervencionista

Fase 1

The University of Texas MD Anderson Cancer Centre

The study described in this protocol is a Phase 1, single center clinical trial to evaluate the safety and potential of [18F]GEH121224 as a PET radiotracer for the diagnostic imaging of HER2 positive breast cancer lesions. A group of 6 patients will be selected to perform a dosimetry study with [18F]GEH121224 followed by another group of 6 patients in a test-retest study. The results of this study will provide crucial information to guide the development of [18F]GEH121224 for the detection of HER2 status in advanced breast cancer patients. This study will use established methods for characterizing the radiation dosimetry, biodistribution and basic pharmacokinetics of a radiotracer.

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Categoría de tratamiento

Radiofármacos, Prueba diagnóstica

Erforderliche Mutationen

HER2

Ensayo iniciado

2026-02-07

Última actualización por el patrocinador

2025-02-06

Finalización estimada

2026-12-01

Elegibilidad

Criterios de inclusión

* Female patients aged ≥18 years

* Willingness and ability to comply with study procedures and signed and dated informed consent

* For women of child-bearing potential, negative urine pregnancy test at screening and o on the day of investigational medicinal product (IMP) administration (with the result known before IMP administration) and willingness to use contraception (barrier, abstinence, non-hormonal) for 3 weeks after injection of [18F]GEH121224

* Life expectancy >3 months

* Diagnosis of locally advanced or metastatic breast cancer

* Target lesion diameter of ≥15 mm that has not been previously treated with radiotherapy

* Histologically confirmed locally advanced/metastatic breast cancer with a biopsy within the past 12 months confirming HER2-positive status by either IHC or FISH from primary tumor

* Previously received no more than 1 prior lines of systemic chemotherapy (including anti HER2 therapy) for metastatic breast cancer

* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2

* Adequate organ function as defined by:

Hemoglobin ≥10 g/dL White blood cell count ≥3.0 × 109/L Platelet count ≥75 × 109/L Serum creatinine ≤1.4 mg/dL Aspartate aminotransferase and alanine aminotransferase ≤2× upper limit of normal (ULN) Total bilirubin ≤2× ULN or 3.0 mg/dL in patients with Gilbert's syndrome

* At least one lesion is fluorodeoxyglucose (FDG)-avid

Criterios de exclusión

* Patient has a primary non-breast malignancy (small dermatological malignancies such as basal cell carcinoma <10 mm are allowed)

* Pregnancy or breast-feeding or, for women of child-bearing potential, unwillingness to use an acceptable form of birth control

* Chronically active hepatitis B or C

* Current history of drug or alcohol abuse or any active liver disease

* Administration of other IMP within 30 days of screening

* Systemic therapy including anti-HER2 therapy within 2 weeks before enrollment

* Ongoing toxicity > grade 2 from previous standard or investigational therapies, according to National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

* History of cardiac disease (myocardial infarction, arrhythmias requiring therapy, symptomatic valvular disease, cardiomyopathy, or pericarditis)

* Evidence of significant medical condition, ongoing severe disease, or laboratory finding that, in the opinion of the Investigator, makes it undesirable for the patient to participate in the study

* Severe claustrophobia, inability to lie flat or fit into the scanner (e.g., body weight ≥350 lbs [160 kg]), or any other inability to tolerate the PET scan

* Known allergies to any product used in this study or any constituents of GEH121224 (18F) Injection

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Detalles del diseño

AsignaciónNon-Randomized

Modelo de intervenciónSequential Assignment

EnmascaramientoNone (Open Label)

Número a inscribir12

Brazos e Intervenciones

Brazos

Intervenciones

Tipo: Experimental

Descripción:

Intervenciones:

GEH121224 (18F) Injection
Dynamic and Static - PET/CT Scan
Static - PET/CT Scan

Medidas de resultado

Medidas de resultado primarias

Specific absorbed dose to the target lesions, specific absorbed dose per organ, and total effective dose of [18F]GEH121224.6 months

Change in injection site status following administration of [18F]GEH121224Before [18F]GEH121224 administration, immediately after dynamic whole body PET/CT scan and single whole body scans

The occurrence of post-administration injection site status outside the normal limits will be summarized.

Occurrence of Adverse Events (AEs) following administration of [18F]GEH1212246 months

An overall summary of AEs, SAEs, and [18F]GEH121224-emergent AEs will be presented, coded using the Medical Dictionary for Regulatory Activities (MedDRA) and summarized by system organ class and preferred term.

Changes in heart rate as beats per minute following administration of [18F]GEH121224Baseline, before [18F]GEH121224 administration, immediately after dynamic whole body PET/CT scan and single whole body scans

The occurrence of post-administration heart rate values outside the normal limits will be summarized.

Changes in blood pressure in mmHg following administration of [18F]GEH121224Baseline, before [18F]GEH121224 administration, immediately after dynamic whole body PET/CT scan and single whole body scans

The occurrence of post-administration blood pressure values outside the normal limits will be summarized.

Changes in temperature as degree C following administration of [18F]GEH121224Baseline, before [18F]GEH121224 administration, immediately after dynamic whole body PET/CT scan and single whole body scans

The occurrence of post-administration body temperature values outside the normal limits will be summarized.

Changes in respiration rate as breaths per minute following administration of [18F]GEH121224Baseline, before [18F]GEH121224 administration, immediately after dynamic whole body PET/CT scan and single whole body scans

The occurrence of post-administration respiration rate values outside the normal limits will be summarized.

Change from baseline in the results of 12-lead electrocardiograms (ECGs) following administration of [18F]GEH121224Baseline, before [18F]GEH121224 administration, immediately after single whole body PET/CT scans

Descriptive statistics will be used to describe the observed values and change from baseline for ECG intervals (PR, QTc, QRS or RR).

Medidas de resultado secundarias

Biodistribution6 months

Time-activity curves will be generated and integrated to obtain the cumulated activity in each region, and these values will be used to determine the internal radiation dosimetry using the Medical Internal Radiation Dose (MIRD) schema.

Reproducibility6 months

Variation in the relative standardized uptake values (SUVs) calculated from test and retest [18F]GEH121224 PET images.

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Sitios del ensayo

The University of Texas MD Anderson Cancer Centre
Houston, Texas, US

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