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
- Darlinghurst, AustraliaSee the site
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced stomach or food-pipe adenocarcinoma, advanced breast cancer, or advanced lung adenocarcinoma. It tests a scan agent, [68Ga]Ga-DWJ155.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Advanced gastroesophageal adenocarcinoma, HR+/HER2- or HER2+ advanced breast cancer, triple-negative breast cancer, or advanced non-small cell lung cancer adenocarcinoma. At least one measurable tumor outside the brain (RECIST v1.1). ECOG performance status 0-2.
- Earlier treatment
- Breast cancer HR+/HER2- and triple-negative: untreated, or on or finished first-line systemic therapy (preferred). HER2+ breast cancer: any prior systemic therapy. Lung: before, during or after first-line systemic therapy. Gastroesophageal: any prior systemic therapy.
- Biomarker or test result
- Lung cancer: if a HER2 immunohistochemistry (IHC) test is routinely done and available, HER2 ≥1+.
Main reasons for not taking part
- eGFR below 40 mL/min/1.73m2
- Platelet count below 75 x 10^9/L
- Hemoglobin below 9 g/dL
- Absolute neutrophil count below 1.0 x 10^9/L
- Inadequate liver function, urinary tract obstruction or urinary incontinence, pregnancy or breastfeeding
Read by machine on 9 November 2026.
Where in Australia
- DarlinghurstDarlinghurst, AustraliaTaking 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.