RECRUITING Phase 1 ClinicalTrials.gov

A Study of [68Ga]Ga-DWJ155 in Adult Patients With Solid Tumors

Sponsor: Novartis Pharmaceuticals • ClinicalTrials.gov ID: NCT07801508

Registry updated: 2026-10-13

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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.

Interventions

[68Ga]Ga-DWJ155 (Diagnostic test)
Radioligand imaging agent

Eligibility criteria

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.

Conditions

Advanced Gastroesophageal Adenocarcinoma Advanced Breast Cancer Triple-negative Breast Cancer Advanced Non-small Cell Lung Cancer

Locations

Novartis Investigative Site — Darlinghurst, New South Wales, Australia
Novartis Investigative Site — Kyoto, Japan

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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