NCT07239986尚未招募2 期
An Open-label, Multicenter Phase 2 Clinical Study on the Efficacy and Safety of BB102 in Patients With Advanced or Unresectable FGF19-overexpressing Hepatocellular Carcinoma
Broadenbio Ltd., Co.2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年12月1日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This is a Phase 2 study to evaluate the efficacy and safety of BB102, a highly selective and potent FGFR4 inhibitor, as monotherapy in subjects with advanced or unresectable FGF19-overexpressing hepatocellular carcinoma. This study has two phase: dose escalation phase and expansion phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Age ≥ 18 years old, with no gender restrictions.
- •(2) Disease progressed after receiving at least one anti-angiogenic and/or immune checkpoint inhibitor (including PD-1, PD-L1, CTLA-4) therapy, or the treatment is not tolerable.
- •(3) Histologically confirmed primary HCC with FGF19 overexpression, which meets the Barcelona Clinic Liver Cancer (BCLC) staging criteria for patients with stage B suitable for systemic therapy or stage C.
- •(4) At least one measurable lesion as defined by RECIST v1.
- •(5) Eastern Cooperative Oncology Group (ECOG) score ≤
- •(6) Expected survival ≥ 3 months.
- •(7) Adequate organ function.
- •(8) Female subjects of childbearing potential must have a negative pregnancy test prior to the first dose and are required to use effective contraception from signing the ICF until 6 months after the last dose of study treatment.
- •(9) Fully informed of the study and voluntarily signed the informed consent form (ICF), and willing to follow and have the ability to complete all trial procedures.
排除标准
- •(1) Use of systemic immunosuppressive or systemic cortisol (≥10 mg prednisone or other equivalent hormones) within 2 weeks.
- •(2) Prior use of selective FGFR4 inhibitor therapy.
- •(3) Use of Tyrosine kinase inhibitor within 2 weeks.
- •(4) Use of systemic chemotherapy, radiotherapy (>30% bone marrow exposure), interventional embolization, ablation therapy and immunotherapycytotoxic chemotherapeutics within 4 weeks.
- •(5) Use of other clinical investigational drug or therapy that was not marketed within 4 weeks.
- •(6) The patient is receiving drugs or therapies prohibited in the protocol and cannot discontinue such use at least 7 days.
- •(7) Pregnant or lactating females.
- •(8) Presence of clinically significant gastrointestinal disorder that may affect the intake, transport, or absorption of the study drug at screening.
- •(9) Patient with history of a second primary malignancy other than hepatocellular carcinoma within 5 years.
- •(10) Presence of clinically symptomatic metastases to the central nervous system or meninges at screening, which, at the investigator's discretion, is not suitable for enrollment.
- •(11) History of severe neurological or psychiatric disorders, including epilepsy, dementia, moderate to severe depression, etc.
- •(12) Clinically significant and uncontrolled cardiovascular diseases.
- •(13) Pulmonary embolism within 6 months.
- •(14) Presence of uncontrollable infectious disease, congenital immunodeficiency disease,acquired immunodeficiency syndrome, syphilis, active hepatitis B, hepatitis C virus (HCV) infection.
研究组 & 干预措施
BB102 treatment
Experimental
干预措施: BB102 (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: From enrollment to the end of treatment assessed up to 12 months
Tumor response measured by radiologic imaging techniques at baseline and throughout the study.
次要结局
- Disease control rate (DCR)(From enrollment to the end of treatment assessed up to 12 months)
- Progression-free survival (PFS)(From enrollment to the end of treatment assessed up to 12 months)
- Time-To-Progression (TTP)(From enrollment to the end of treatment assessed up to 12 months)
- Duration of response (DOR)(From enrollment to the end of treatment assessed up to 12 months)
- Number of subjects with adverse events (AEs) and serious adverse events (SAEs)(From enrollment to the end of treatment assessed up to 12 months)
研究者
研究点 (2)
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