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 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 obtainedwithin 7 days before enrollment (creatinine: ≤ ULN ×1.5)

• Patients who meet the following laboratory criteria of bone marrow function asevidenced by laboratory data obtained within 7 days before enrollment: Neutrophilcount;≥1500/μL, Platelet count; ≥75000/μL, Hemoglobin;≥9.0 g/dL.

• Patients having Solid Tumors with no standard therapy available or refractory orintolerable to standard therapy (Part2, 3)

• Patients with Child-Pugh A or B (Part2, 3)

• Patients with Malignant Melanoma who are refractory or intolerant to standardtherapy (Part 4)

Inclusion Criteria:(Part 5)

• Patients who provide voluntary written informed consent to participate in the studyfrom 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 informedconsent

• Patients with a Lansky Performance Status (LPS) of ≥70 (for patients aged 15 yearsor younger) or a Karnofsky Performance Status (KPS) of ≥70 (for patients aged 16years or older)

• Patients with preserved renal function as evidenced by laboratory data obtainedwithin 7 days before enrollment (eGFR ≥60 mL/min/1.73 m²)

• Pediatric patients with cancers with no standard therapy available or refractory orintolerable 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, radiationtherapy, 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 beforeenrollment

• Patients with current or previous inadequately controlled or clinically significantcardiac disease

• Patients who, in the opinion of the investigator or subinvestigator, is notappropriate