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.
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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
66
CBA-1205: 0.1, 0.3, 1, 3, 10, 20, 30 mg/kg (Intravenous solution)
CBA-1205: 20 mg/kg and 30 mg/kg (Intravenous solution)
CBA-1205: 30 mg/kg (Intravenous solution)
CBA-1205: 20 mg/kg (Intravenous solution)
CBA-1205: 10 mg/kg (The initial cohort, Intravenous solution)
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
RECRUITINGKanagawa Cancer Center
Yokohama, Kanagawa, Japan
RECRUITINGNiigata University Medical and Dental Hospital
Niigata, Niigata, Japan
RECRUITINGNational Cancer Center Hospital
Chūō, Tokyo, Japan
RECRUITINGUniversity of Yamanashi Hospital
Chūō, Yamanashi, Japan
RECRUITINGDose limiting toxicity
DLTs are assessed according to CTCAE v.5.0 during the first cycle (28 days).
Time frame: Part 1, 2 and 5 - Dose limiting toxicity : For 28 days after the first dose of study treatment
Adverse Event
An adverse event is any untoward or unintended sign, symptom, or disease in a subject administered an investigational product, whether or not it is related to the investigational product
Time frame: Adverse event : Maximum 12 months
Serum CBA-1205 concentration
Blood samples are collected to assess the serum concentration of CBA-1205.
Time frame: From Day 1 to Day 43 (or until Discontiuation of treatment)
Immunogenicity
Blood samples are collected to assess the serum anti-CBA-1205 antibody.
Time frame: From Day1 to Day 43 (or until Discontiuation of treatment)
Efficacy
Antitumor response evaluated in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Tumor markers
Time frame: Screening, Day 1 of Cycle 2 and 3, and Day 1 of even-numbered cycles from Cycle 4 onward until treatment discontinuation. Maximum 12 months
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