Hepatocellular Carcinoma (HCC), Malignant Melanoma, Pediatric Cancer, Solid Tumors
Conditions
Keywords
DLK1, First in human, Phase I, Antibody, solid tumor, Hepatocellular Carcinoma, CBA-1205, Melanoma, Pediatric Cancer
Brief summary
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.
Detailed 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
Interventions
DRUGCBA-1205 Part 1
CBA-1205: 0.1, 0.3, 1, 3, 10, 20, 30 mg/kg (Intravenous solution)
DRUGCBA-1205 Part 2
CBA-1205: 20 mg/kg and 30 mg/kg (Intravenous solution)
DRUGCBA-1205 Part 3
CBA-1205: 30 mg/kg (Intravenous solution)
DRUGCBA-1205 Part 4
CBA-1205: 20 mg/kg (Intravenous solution)
DRUGCBA-1205 Part 5
CBA-1205: 10 mg/kg (The initial cohort, Intravenous solution)
Sponsors
Chiome Bioscience Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose limiting toxicity | Part 1, 2 and 5 - Dose limiting toxicity : For 28 days after the first dose of study treatment | DLTs are assessed according to CTCAE v.5.0 during the first cycle (28 days). |
| Adverse Event | Adverse event : Maximum 12 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum CBA-1205 concentration | From Day 1 to Day 43 (or until Discontiuation of treatment) | Blood samples are collected to assess the serum concentration of CBA-1205. |
| Immunogenicity | From Day1 to Day 43 (or until Discontiuation of treatment) | Blood samples are collected to assess the serum anti-CBA-1205 antibody. |
| Efficacy | 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 | Antitumor response evaluated in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Tumor markers |
Countries
Japan
Contacts
CONTACTTanaka Miseri Chiome Bioscience Inc.
CONTACTGeneral Affairs and Human Resources Department Chiome Bioscience Inc.
Outcome results
None listed