This is a phase I, open label first in human study to evaluate the imaging performance, safety, biodistribution and pharmacokinetics of \[68Ga\]Ga-DWJ155 in patients ≥ 18 years of age with hormone receptor positive/HER2 negative (HR+/HER2-) and HER2 positive (HER2+) advanced breast cancer (aBC) and advanced Non-Small Cell Lung Cancer (aNSCLC) adenocarcinoma.
This is a first-in-human (FIH), open-label, phase I radioligand imaging study designed to assess the biodistribution, imaging, safety, PK and dosimetry properties in patients with aBC and aNSCLC adenocarcinoma. Approximately 15-21 aBC and 9-15 aNSCLC patients will be enrolled into the study. All patients enrolled in the study will receive a single administered radioactive dose of FKL480. The study will consist of an imaging characterization part and an expansion part.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
36
Radioligand imaging agent
Standard Uptake Value (SUV) mean and max of FKL480 uptake in normal organs and tumor lesions over time
Imaging properties of FKL480 will be evaluated by assessing radiotracer uptake, identified via positron emission tomography (PET) scans. The SUVmean and SUVmax will be calculated and reported with summary statistics.
Time frame: Up to 240 minutes after dosing on Day 1
Standard Uptake Value ratio (SUVr) of FKL480 uptake in normal organs and tumor lesions over time
SUVr will be calculated by dividing the SUV of the lesions by the SUV of the different organs in order to identify the reference organ with the lowest uptake and the respective SUVr (i.e. using SUVmean or SUVmax).
Time frame: Up to 240 minutes after dosing on Day 1
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Incidence and severity of AEs and SAEs, including changes in vital signs and laboratory values qualifying and reported as AEs.
Time frame: Up to 3 days after single dose administration on Day 1
Dosimetry sub-group: Observed maximum concentration (Cmax) of FKL480 based on blood radioactivity data
The FKL480 pharmacokinetic analysis will be performed based on blood radioactivity concentration data, obtained by measuring in gamma-counting equipment the blood samples.
Time frame: Up to 240 minutes after dosing on Day 1
Dosimetry sub-group: Observed area under the curve (AUC) from time zero to the last measurable concentration sampling time (AUClast) of FKL480 based on blood radioactivity data
The FKL480 pharmacokinetic analysis will be performed based on blood radioactivity concentration data, obtained by measuring in gamma-counting equipment the blood samples
Time frame: Up to 240 minutes after dosing on Day 1
Novartis Pharmaceuticals
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Dosimetry sub-group: Observed time to reach maximum (Tmax) after single dose administration of FKL480 based on blood radioactivity data
The FKL480 pharmacokinetic analysis will be performed based on blood radioactivity concentration data, obtained by measuring in gamma-counting equipment the blood samples
Time frame: Up to 240 minutes after dosing on Day 1
Dosimetry sub-group: Urinary excretion of FKL480
The elimination of the compound in urine will be evaluated based on urine radioactivity concentration data obtained by measuring in gamma counting equipment the urine samples.
Time frame: Up to 240 minutes after dosing on Day 1
Dosimetry sub-group: Absorbed radiation dose in normal tissues and total body
Absorbed radiation dose coefficients in selected organs and lesions and total body as measured by image quantification.
Time frame: Up to 240 minutes after dosing on Day 1
Dosimetry sub-group: Effective dose
Effective dose in selected organs and total body as measured by image quantification.
Time frame: Up to 240 minutes after dosing on Day 1