A Study of [68Ga]Ga-DWJ155 in Adult Patients With Solid Tumors
Recruiting · NCT07801508 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
[68Ga]Ga-DWJ155
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
- Key
Exclusion criteria
- 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
- ther protocol-defined inclusion/exclusion criteria may apply.
Where it is running
2 locations listed.
- Novartis Investigative Site - Kyoto, Japan
- Novartis Investigative Site - Kyoto, Japan