Clinical Trial Finder

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

To evaluate safety and efficacy of CBA-1205 in the following five parts in a stepwise manner: Part 1.

• - In Part 1, safety and tolerability in patients with Solid Tumor where no standard treatment is available, or who are intolerable or non-responder to the standard treatment will be evaluated.

Initial dose for Part 2 will be determined. Part 2.

• - In Part 2, safety and tolerability in patients with advanced and/or recurrent Hepatocellular Carcinoma which are unresectable, or who are intolerable or non-responder to the standard treatment will be evaluated.

Recommended dose in this population will be determined. Part 3.

• - In Part 3, safety and efficacy at the recommended dose in patients with advanced and/or recurrent Hepatocellular Carcinoma which are unresectable, or who are intolerable or non-responder to the standard treatment will be evaluated.

Part 4.

• - In Part 4, safety and efficacy in patients with Malignant Melanoma who are refractory or intolerant to standard therapy.

Part 5.

• - In Part 5, safety, tolerability and the recommended dose of the study drug in patients with Pediatric Cancer where no standard treatment is available, or who are intolerable or non-responder to the standard treatment will be evaluated.

PK analysis

Arms

Experimental: CBA-1205: Part 1

CBA-1205 injection is administered at 2-week intervals in seven cohorts (0.1, 0.3, 1, 3, 10, 20, 30 mg/kg) in patients with solid tumor. Note: In the study treatment period, CBA-1205 is intravenously administered at 2-week intervals in a 28-day cycle.

Experimental: CBA-1205: Part 2

CBA-1205 (20, 30 mg/kg) injection is administered at 2-week intervals in 28-day cycles in patients with HCC . Note: The study drug is administered at 2-week intervals until any of the criteria for discontinuation of study treatment are met.

Experimental: CBA-1205: Part 3

CBA-1205 injection is administered at 2-week intervals in 28-day cycles in patients with HCC. Note: The study drug is administered at 2-week intervals until any of the criteria for discontinuation of study treatment are met.

Experimental: CBA-1205 : Part 4

CBA-1205 injection is administered at 2-week intervals in 28-day cycles in patients with Malignant Melanoma. Note: The study drug is administered at 2-week intervals until any of the criteria for discontinuation of study treatment are met.

Experimental: CBA-1205: Part 5

CBA-1205 injection is administered at 2-week intervals in 28-day cycles in patients with Pediatric Cancer. Note: The study drug is administered at 2-week intervals until any of the criteria for discontinuation of study treatment are met.

Interventions

Drug: - CBA-1205 Part 1

CBA-1205: 0.1, 0.3, 1, 3, 10, 20, 30 mg/kg (Intravenous solution)

Drug: - CBA-1205 Part 2

CBA-1205: 20 mg/kg and 30 mg/kg (Intravenous solution)

Drug: - CBA-1205 Part 3

CBA-1205: 30 mg/kg (Intravenous solution)

Drug: - CBA-1205 Part 4

CBA-1205: 20 mg/kg (Intravenous solution)

Drug: - CBA-1205 Part 5

CBA-1205: 10 mg/kg (The initial cohort, Intravenous solution)