Phase 1, Single-center, Open-label, Clinical Imaging Study.

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GE Healthcare
• Collaborator: Laboratory Corporation of America

Criteria

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