Testing a Scan Tracer, [68Ga]Ga-DWJ155, in Adults With Advanced Solid Tumors
Tests a new imaging agent in adults with advanced stomach, breast or lung cancer.
Plain-language title generated from the registry record
Registry title: A Study of [68Ga]Ga-DWJ155 in Adult Patients With Solid Tumors
Key facts
- Where
- Kyoto, JapanSee the site
- Phase
- Phase 1
Where in Japan
- KyotoKyoto, JapanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novartis Pharmaceuticals
- Trial code
- NCT07801508
- Record updated
- 13 October 2026
- Original description
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.Read full original descriptionShow less
A Phase I, Open Label Study to Evaluate the Imaging Characteristics, Safety, Biodistribution and Pharmacokinetics of [68Ga]Ga-DWJ155 in Adult Patients With Solid Tumors
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.
Inclusion: 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; Patients with one of the following indications:; 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; aNSCLC adenocarcinoma: Prior to, during or having completed their first line of systemic therapy. If HER2 immunohistochemistry (IHC) will be routinely performed and available, then HER2 ≥1+; aGEA: regardless of any prior systemic line of therapy.
Exclusion: Out-of-range laboratory values defined as:; 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; Patients with inadequate hepatic function; Urinary tract obstruction or urinary incontinence; Pregnant or breastfeeding women; Other protocol-defined inclusion/exclusion criteria may apply.