A Phase I, First in Human Study of CBA-1205, Anti-DLK1 Monoclonal Antibody in Patients with Advanced Solid Tumors and Hepatocellular Carcinoma (HCC)
- Registration Number
- NCT06636435
- Lead Sponsor
- Chiome Bioscience Inc.
- Brief Summary
In this first-in-human, multicenter,non-randomized, open-label, standard 3+3 dose escalation Phase I study encompasses 3parts(Part1-3). 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 three parts in a stepwise manner:
* 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.
* 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.
* 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.
* PK analysis
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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
- Patients with unresectable advanced/recurrent hepatocellular carcinoma refractory or intolerable to standard therapy (Part2, 3: HCC)
- Patients with Child-Pugh A or B (Part2, 3; HCC)
Exclusion criteria:
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description CBA-1205: Part 3 CBA-1205 CBA-1205 (30 mg/kg) injection is administered at 2-week intervals in 28-day cycles for HCC patients. In the study treatment period, the study drug is administered at 2-week intervals. CBA-1205: Part 1 CBA-1205 CBA-1205 injection is administered at 2-week intervals in seven cohorts (0.1, 0.3, 1, 3, 10, 20, 30 mg/kg) for solid tumor. In the study treatment period, CBA-1205 is intravenously administered at 2-week intervals in a 28-day cycle. CBA-1205: Part 2 CBA-1205 CBA-1205 (20, 30 mg/kg) injection is administered at 2-week intervals in 28-day cycles for HCC patients. In the study treatment period, the study drug is administered at 2-week intervals.
- Primary Outcome Measures
Name Time Method Adverse Event Maximum12 months Adverse Event
Dose limiting toxicity Part 1, 2, : Within 28 days after the first dose of study treatment Dose limiting toxicity
- Secondary Outcome Measures
Name Time Method Pharmacokinetics Cycle1 Day1, Day2, Day3, Day4, Day8, Day15, Cycle2 Day1, and Cycle2 Day15. Each cycle is 28 days. PK variable: Serum CBA-1205 concentration
Immunogenicity At Cycle1 Day1, Day15, and Cycle 2 Day1, Day15 (Each cycle is 28 days) Immunogenicity variable:
Serum anti-CBA-1205 antibody concentrationEfficacy Time Frame: screening period (within 28 days before the start of the study drug), on day 1 of cycles 2, 4, and subsequent even cycles. Each cycle is 28 days * Antitumor response evaluated in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and
* Tumor markers
Trial Locations
- Locations (4)
National Cancer Center Hospital East
🇯🇵Kashiwa, Chiba, Japan
Kanagawa Cancer Center
🇯🇵Yokohama, Kanagawa, Japan
National Cancer Center Hospital
🇯🇵Chuo, Tokyo, Japan
Niigata University Medical and Dental Hospital
🇯🇵Niigata, Japan