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

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.

This is an open-label, Phase I radioligand imaging study designed to assess the biodistribution, imaging, safety, pharmacokinetics (PK), and dosimetry properties of [68Ga]Ga-DWJ155.

HER2 status for enrollment will be determined based on the most recent, locally available tumor tissue sample and corresponding HER2 results, in accordance with the American Society of Clinical Oncology (ASCO) / College of American Pathologists (CAP) guidelines, as applicable.

This study comprises an imaging characterization part and an expansion part. During the imaging characterization part, the imaging characteristics of [68Ga]Ga-DWJ155 (e.g., biodistribution, tumor uptake, and radiation dosimetry) will be assessed, as well as the optimal imaging time point for tumor visualization. The expansion part may be initiated if positive tumor uptake is observed in patients during the imaging characterization part.

The estimated study duration for each individual patient is up to approximately 32 days, including a screening period of up to 28 days, a single-day imaging period (including [68Ga]Ga-DWJ155 administration and assessments), and a 3-day safety follow-up.

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.