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.
Age ≥ 18 years old
Presence of at least one extracranial measurable lesion by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
HR+/HER2- aBC and TNBC: untreated or currently receiving or having completed first line of systemic therapy (preferred); HER2+ aBC: regardless of any prior systemic therapy
Estimated glomerular filtration rate (eGFR; calculated using CKD-EPI 2021 formula, or measured) < 40 mL/min/1.73m2
Platelet count < 75 x 10^9/L
Hemoglobin < 9 g/dL
Absolute neutrophil count (ANC) < 1.0 x 10^9/L
Single group
[68Ga]Ga-DWJ155
Diagnostic testRadioligand imaging agent
Standard 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.
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.
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.
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.
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.
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.
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