Overview
In this first-in-human, muticenter, non-randomized, open-label, standard 3+3 dose escalation Phase I study encompasses 5 parts (Part 1-5). The purpose of this FIH study is to evaluate the safety and tolerability profile of CBA-1205.
Description
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
Eligibility
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