The purpose of this study is to evaluate the imaging characteristics, safety, biodistribution and pharmacokinetics (PK) of \[68Ga\]Ga-DWJ155, also known as FKL480, in patients ≥ 18 years of age with advanced gastroesophageal adenocarcinoma (aGEA, where GEA is defined as adenocarcinomas of the distal esophagus, the gastroesophageal junction, and the stomach), hormone receptor (HR) positive/human epidermal growth factor receptor 2 (HER2) negative (HR+/HER2-) advanced breast cancer (aBC), HER2 positive (HER2+) aBC, triple-negative breast cancer (TNBC) and advanced non-small cell lung cancer (aNSCLC) adenocarcinoma.
This is an open-label, Phase I radioligand imaging study designed to assess the biodistribution, imaging, safety, pharmacokinetics (PK), and dosimetry properties of \[68Ga\]Ga-DWJ155. HER2 status for enrollment will be determined based on the most recent, locally available tumor tissue sample and corresponding HER2 results, in accordance with the American Society of Clinical Oncology (ASCO) / College of American Pathologists (CAP) guidelines, as applicable. This study comprises an imaging characterization part and an expansion part. During the imaging characterization part, the imaging characteristics of \[68Ga\]Ga-DWJ155 (e.g., biodistribution, tumor uptake, and radiation dosimetry) will be assessed, as well as the optimal imaging time point for tumor visualization. The expansion part may be initiated if positive tumor uptake is observed in patients during the imaging characterization part. The estimated study duration for each individual patient is up to approximately 32 days, including a screening period of up to 28 days, a single-day imaging period (including \[68Ga\]Ga-DWJ155 administration and assessments), and a 3-day safety follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
66
Radioligand imaging agent
Novartis Investigative Site
Kyoto, Japan
RECRUITINGStandard uptake values (SUVs) of [68Ga]Ga-DWJ155 in selected organs, normal tissue and tumor lesions
Standardized uptake values (SUVs) will be measured in organs of interest, normal tissues, and tumor lesions based on positron emission tomography (PET) imaging.
Time frame: Up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155
Standardized uptake value ratio (SUVr) of [68Ga]Ga-DWJ155 in tumor lesions relative to reference organs
Standardized uptake value ratios (SUVr) will be calculated as the ratio of SUV in tumor lesions to SUV in normal organs.
Time frame: Up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Incidence and severity of AEs and SAEs, including changes in laboratory values, vital signs and echocardiograms (ECGs) qualifying and reported as AEs.
Time frame: Up to 3 days after the administration of [68Ga]Ga-DWJ155
Area under the concentration-time curve (AUC) of blood radioactivity (Imaging characterization part only)
Pharmacokinetic (PK) analysis will be performed in the imaging characterization part based on decay-corrected blood radioactivity concentration data. These data will be converted to mass units for PK analysis, and AUC will be determined using non-compartmental methods.
Time frame: From pre-dose up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155
Maximum observed concentration (Cmax) of blood radioactivity (Imaging characterization part only)
PK analysis will be performed in the imaging characterization part based on decay-corrected blood radioactivity concentration data. These data will be converted to mass units for PK analysis, and Cmax will be determined using non-compartmental methods.
Time frame: From pre-dose up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155
Absorbed radiation dose in selected organs and total body (Imaging characterization part only)
Absorbed radiation dose will be estimated for organs of interest and whole body based on serial positron emission tomography (PET) imaging.
Time frame: Up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155
Effective radiation dose (Imaging characterization part only)
Effective radiation dose will be calculated based on the estimated absorbed radiation doses in source organs, with adjustments for individual body weight and organ masses (derived from computed tomography imaging).
Time frame: Up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155
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