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

RecruitingPhase 1Ages 18 Years - anyAllNovartis Pharmaceuticals
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In plain words

What the trial is, and whether it could suit you

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 โ‰ฅ 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.

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๐Ÿ“‹ Eligibility rules (as published)
Key Inclusion Criteria: * Age โ‰ฅ 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 โ‰ฅ1+ * 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.
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What it tests

  • [68Ga]Ga-DWJ155
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Where

2 sites
Novartis Investigative Site
Darlinghurst, Australia
Novartis Investigative Site
Kyoto, Japan
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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