Clinical trial · Interventional
A Study of [68Ga]Ga-DWJ155 in Adult Patients With Solid Tumors
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Advanced Gastroesophageal Adenocarcinoma | — | UNRESOLVED | — |
| Advanced Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Triple-negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [68Ga]Ga-DWJ155 | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [68Ga]Ga-DWJ155
- description
- Single administration of \[68Ga\]Ga-DWJ155
- interventionNames
- Diagnostic Test: [68Ga]Ga-DWJ155
Primary outcomes (2)
- measure
- Standard uptake values (SUVs) of [68Ga]Ga-DWJ155 in selected organs, normal tissue and tumor lesions
- timeFrame
- Up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155
- description
- Standardized uptake values (SUVs) will be measured in organs of interest, normal tissues, and tumor lesions based on positron emission tomography (PET) imaging.
- measure
- Standardized uptake value ratio (SUVr) of [68Ga]Ga-DWJ155 in tumor lesions relative to reference organs
- timeFrame
- Up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key 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 Other protocol-defined inclusion/exclusion criteria may apply.
References
Publications (0)
Data not yet available