The purpose of this phase I study is to evaluate the safety, tolerability, dosimetry, and preliminary anti-tumor activity of \[177Lu\]Lu-DWJ155 and the safety and imaging properties of \[68Ga\]Ga-DWJ155 in patients with histologically or cytologically confirmed advanced HER2+, HR+/HER2-negative, or triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), HER2-3+ or 2+ (ISH positive or negative) gastric/gastroesophageal junction (GEJ) cancer, and bladder cancer.
Male or female patients age ≥ 18 years.
Advanced HER2+ breast cancer with disease progression after at least two prior lines of systemic therapy in the advanced setting
Advanced HR+/HER2-low breast cancer with disease progression after prior therapy in the advanced setting
Advanced NSCLC without actionable genetic alterations (AGAs) with disease progression after prior therapy in the advanced setting
Creatinine clearance < 60 mL/min (calculated using CKD-EPI 2021 formula, or measured)
Total bilirubin > 1.5 x ULN (except for patients with Gilbert's syndrome who are excluded if total bilirubin >3.0 x ULN) or direct bilirubin > 1.5 x ULN
Alanine aminotransferase (ALT) > 3 x ULN, except for patients with tumor involvement of the liver who are excluded if ALT > 5 x ULN
Aspartate aminotransferase (AST) > 3 x ULN, except for patients with tumor involvement of the liver who are excluded if AST > 5 x ULN
Novartis Pharmaceuticals
Lead sponsor