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

RecruitingPhase 1

Sponsor: Novartis Pharmaceuticals

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

Interventions: [68Ga]Ga-DWJ155

Countries: Japan

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (1)

Kyoto, Japan