A Phase I, First in Human Study of CBA-1205, Anti-DLK1 Monoclonal Antibody in Patients With Advanced Solid Tumors, Hepatocellular Carcinoma (HCC), Melanoma, and Pediatric Cancer

Inclusion Criteria12

• Patients who provide voluntary written informed consent to participate in the study
• Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of≤1
• Patients with preserved renal function as evidenced by laboratory data obtained within 7 days before enrollment (creatinine: ≤ ULN ×1.5)
• Patients who meet the following laboratory criteria of bone marrow function as evidenced by laboratory data obtained within 7 days before enrollment: Neutrophil count;≥1500/μL, Platelet count; ≥75000/μL, Hemoglobin;≥9.0 g/dL.
• Patients having Solid Tumors with no standard therapy available or refractory or intolerable to standard therapy (Part2, 3)
• Patients with Child-Pugh A or B (Part2, 3)
• Patients with Malignant Melanoma who are refractory or intolerant to standard therapy (Part 4)
• Patients who provide voluntary written informed consent to participate in the study from both the subject (if aged 16 years or older) and their legal representatives
• Japanese patients aged 2 years or older and under 20 years at the time of informed consent
• Patients with a Lansky Performance Status (LPS) of ≥70 (for patients aged 15 years or younger) or a Karnofsky Performance Status (KPS) of ≥70 (for patients aged 16 years or older)
• Patients with preserved renal function as evidenced by laboratory data obtained within 7 days before enrollment (eGFR ≥60 mL/min/1.73 m²)
• Pediatric patients with cancers with no standard therapy available or refractory or intolerable to the standard therapy