NCT07801508RecruitingPhase 1
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 · Last updated 13 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 66 (estimated)
- First submitted
- 31 Aug 2026
- Start date
- Sept 2026
- Primary completion date
- Jun 2028
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Triple-negative breast cancer, Lung cancer, Metastatic breast cancer, Gastric and esophageal cancer
- NCT number
- NCT07801508
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 66
- From Sept 2026 to the primary completion date, Jun 2028
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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
Other
- Patients with inadequate hepatic function
- Urinary tract obstruction or urinary incontinence
- Pregnant or breastfeeding women
- Other protocol-defined inclusion/exclusion criteria may apply.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Darlinghurst | Australia | Recruiting |
| - Coordinator of this site? Confirm its status | Kyoto | Japan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.