A Phase 1 Study to Assess the Safety, Radiation Dosimetry and Biodistribution, and Basic Pharmacokinetics of [18F]GEH121224 and Determine the Optimal Timing of Imaging in Patients With Locally Advanced or Metastatic Breast Cancer.

GE-226-004

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.

2025-01-01

2025-12-01

2025-12-01

Not yet recruiting

Early phase I

12

Inclusion Criteria: * 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 Exclusion Criteria: * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Patients will be enrolled into 1 of 2 groups in a sequential manner. Group 1 will allow to study \\[18F\\]GEH121224 Biodistribution and Radiation Dosimetry. Group 2 will allow to study \\[18F\\]GEH121224 PET/CT Scan Test Retest.', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 12, 'type': 'ESTIMATED'}}

2024-02-23