A Phase I, First in Human Study of CBA-1205, Anti-DLK1 Monoclonal Antibody in Patients With Advanced Solid Tumors.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 10
- 主要终点
- Dose limiting toxicity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: CBA-1205 Part 1 (Drug)
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.
干预措施: CBA-1205 Part 2 (Drug)
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.
干预措施: CBA-1205 Part 3 (Drug)
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.
干预措施: CBA-1205 Part 4 (Drug)
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.
干预措施: CBA-1205 Part 5 (Drug)
结局指标
主要结局
Dose limiting toxicity
时间窗: 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
时间窗: 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
次要结局
- Serum CBA-1205 concentration(From Day 1 to Day 43 (or until Discontiuation of treatment))
- Immunogenicity(From Day1 to Day 43 (or until Discontiuation of treatment))
- 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)