Un estudio de fase I, el primero en humanos, de CBA-1205, un anticuerpo monoclonal anti-DLK1 en pacientes con tumores sólidos avanzados, carcinoma hepatocelular (CHC), melanoma y cáncer pediátrico.

Inclusion Criteria:(Part 1-4)

• 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)

Inclusion Criteria:(Part 5)

• 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

Exclusion criteria: (Part1-5)

• Patients who have undergone major surgery within 28 days before enrollment
• Patients who have received anticancer treatment with surgical therapy, radiation therapy, and/or drug therapy within 14 days before enrollment
• Patients who have received anticancer treatment with immune checkpoint inhibitor, etc. within 28 days before enrollment
• Patients with Grade 2 or higher concurrent disease or prior therapy-related toxicity
• Patients who have received any other investigational product within 28 days before enrollment
• Patients with current or previous inadequately controlled or clinically significant cardiac disease
• Patients who, in the opinion of the investigator or subinvestigator, is not appropriate