A Study of [68Ga]Ga-DWJ155 in Adult Patients With Solid Tumors
NCT07801508 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66
Last updated 2026-09-03
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.
Conditions
- Advanced Gastroesophageal Adenocarcinoma
- Advanced Breast Cancer
- Triple-negative Breast Cancer
- Advanced Non-small Cell Lung Cancer
Interventions
- DIAGNOSTIC_TEST
-
[68Ga]Ga-DWJ155
Radioligand imaging agent
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-22
- Primary Completion
- 2028-06-30
- Completion
- 2028-06-30
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