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

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.