A Phase I Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Dosimetry, and Preliminary Activity of [177Lu]Lu-DWJ155 and Safety and Imaging Properties of [68Ga]Ga-DWJ155 in Patients With Solid Tumors
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.
• Patients with one of the following histologically or cytologically confirmed and documented malignancies who have progressed on or been intolerant to standard of care therapy, and are not considered appropriate for any standard therapy with proven benefit, in the investigator's judgment:
• Dose Escalation:
‣ 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
⁃ Advanced NSCLC with AGAs who have received prior treatment
⁃ Measurable disease as determined by RECIST version 1.1.
• Dose Expansion:
‣ 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 HR+/HER2 0 breast cancer with disease progression after prior therapy in the advanced setting
⁃ Advanced HR-/HER2-low breast cancer with disease progression after prior therapy in the advanced setting
⁃ Advanced HR-/HER2 0 breast cancer with disease progression after prior therapy in the advanced setting
⁃ Advanced NSCLC with AGAs, who have received prior treatment
⁃ Advanced NSCLC without known AGAs who have received prior treatment.
⁃ Advanced gastric/GEJ cancer with HER2 IHC 3+ or 2+ (ISH + or -), following disease progression after prior therapy in the advanced setting
⁃ Advanced bladder cancer following disease progression after prior therapy in the advanced setting
⁃ Measurable disease as determined by RECIST version 1.1.