Life sciences · Phase 1 Trial
ClinicalTrials.gov · October 13, 2026
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Phase 1 Trial.
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Registry record from ClinicalTrials.gov (NCT07801508). This is a study registration, not published results. Lead sponsor: Novartis Pharmaceuticals. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 66 participants (ESTIMATED). Conditions: Advanced Gastroesophageal Adenocarcinoma, Advanced Breast Cancer, Triple-negative Breast Cancer, Advanced Non-small Cell Lung Cancer. Interventions: DIAGNOSTIC_TEST: [68Ga]Ga-DWJ155. Primary outcome measures: Standard uptake values (SUVs) of [68Ga]Ga-DWJ155 in selected organs, normal tissue and tumor lesions , 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 , Up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155. Brief summary: 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.