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

NCT05634954 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: GE-226-004
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

HER2 positive; Breast Oncology

Outcome Measures

Primary Outcomes (8)

• 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]GEH121224

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

  Before [18F]GEH121224 administration, immediately after dynamic whole body PET/CT scan and single whole body scans

• Occurrence of Adverse Events (AEs) following administration of [18F]GEH121224

  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.

  6 months

• Changes in heart rate as beats per minute following administration of [18F]GEH121224

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

  Baseline, before [18F]GEH121224 administration, immediately after dynamic whole body PET/CT scan and single whole body scans

• Changes in blood pressure in mmHg following administration of [18F]GEH121224

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

  Baseline, before [18F]GEH121224 administration, immediately after dynamic whole body PET/CT scan and single whole body scans

• Changes in temperature as degree C following administration of [18F]GEH121224

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

  Baseline, before [18F]GEH121224 administration, immediately after dynamic whole body PET/CT scan and single whole body scans

• Changes in respiration rate as breaths per minute following administration of [18F]GEH121224

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

  Baseline, before [18F]GEH121224 administration, immediately after dynamic whole body PET/CT scan and single whole body scans

• Change from baseline in the results of 12-lead electrocardiograms (ECGs) following administration of [18F]GEH121224

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

  Baseline, before [18F]GEH121224 administration, immediately after single whole body PET/CT scans

Secondary Outcomes (2)

• Biodistribution

  6 months

• Reproducibility

  6 months

Study Arms (2)

[18F]GEH121224 - Group 1 - Biodistribution

EXPERIMENTAL

Drug: GEH121224 (18F) Injection; Diagnostic Test: Dynamic and Static - PET/CT Scan

[18F]GEH121224 - Group 2 - Reproducibility

EXPERIMENTAL

Drug: GEH121224 (18F) Injection; Diagnostic Test: Static - PET/CT Scan

Interventions

GEH121224 (18F) Injection DRUG

Single GEH121224 (18F) Injection

[18F]GEH121224 - Group 1 - Biodistribution; [18F]GEH121224 - Group 2 - Reproducibility

Dynamic and Static - PET/CT Scan DIAGNOSTIC_TEST

Group 1: Dynamic whole-body PET/CT scan will start at the time of injection (8 sequential scans over 90 minutes anticipated) followed by static whole-body scans starting at 120 minutes and 240 minutes after injection.

[18F]GEH121224 - Group 1 - Biodistribution

Static - PET/CT Scan DIAGNOSTIC_TEST

Group 2: Static whole-body scans

[18F]GEH121224 - Group 2 - Reproducibility

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GE Healthcare: lead
• Laboratory Corporation of America: collaborator

Study Sites (1)

The University of Texas MD Anderson Cancer Centre

Houston, Texas, 77030-4008, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Injections

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Eduard Zhalovaga, MD, PhD

  GE Healthcare Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 2, 2022
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)