An Open-Label, Multiple-Dose Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GKL-006 Injection in Patients With Unresectable Hepatocellular Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 6
- 试验地点
- 3
- 主要终点
- Incidence and Severity of Treatment-Related Adverse Events and Safety/Tolerability Risks
研究概览
简要总结
This is a Phase 1b study of GKL-006 Injection in patients with unresectable hepatocellular carcinoma.
详细描述
This Phase 1b study evaluates multiple doses of GKL-006 Injection in participants with unresectable hepatocellular carcinoma (HCC).
The purpose of this study is to evaluate the safety and tolerability of multiple doses of GKL-006 Injection. The study will also evaluate pharmacokinetic and pharmacodynamic characteristics of GKL-006 Injection, how it affects the body, and whether it shows preliminary anti-tumor activity in patients with HCC according to mRECIST.
Participants will receive GKL-006 Injection and TACE treatment. They will be followed for adverse events, tumor response, disease progression, subsequent anti-tumor therapy, and survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Voluntarily participates in the study and provides written informed consent.
- •Has pathologically, cytologically, or radiologically confirmed unresectable hepatocellular carcinoma.
- •Has CNLC stage II to IIIa disease.
- •Has not received transarterial chemoembolization within 6 months before screening.
- •Has at least one measurable lesion according to mRECIST.
- •Child-Pugh class A or B.
- •ECOG performance status of 0 -
- •Has not received radiotherapy, chemotherapy, targeted therapy, or immunosuppressive therapy within 4 weeks before screening.
排除标准
- •Has a known allergy to the investigational product or related components, including human serum albumin.
- •Has another incurable malignancy within 5 years before screening or concurrently, except for cured basal cell carcinoma of the skin, carcinoma in situ, or breast cancer without recurrence for more than 3 years after radical surgery.
- •Has a previous diagnosis of mixed or rare histologic subtypes, including fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or combined hepatocellular-cholangiocarcinoma.
- •Has major vascular invasion on imaging.
- •Has hepatic encephalopathy within 4 weeks before screening.
- •Has clinically symptomatic ascites or pleural effusion requiring drainage, or has undergone thoracic or abdominal fluid drainage within 2 weeks before enrollment.
结局指标
主要结局
Incidence and Severity of Treatment-Related Adverse Events and Safety/Tolerability Risks
时间窗: From the start of study treatment through 14 days after the fourth treatment; treatment-related adverse events will continue to be assessed according to the study protocol.
Treatment-related adverse events and laboratory abnormalities will be assessed and graded according to NCI CTCAE v5.0. Safety and tolerability risks include study treatment-related adverse events or laboratory abnormalities occurring.
次要结局
- Progression-Free Survival (PFS) Based on mRECIST(From enrollment to the first documented disease progression or death from any cause, up to 18 months.)
- Overall Survival(From enrollment until death or the end of study follow-up, approximatelly 30 months.)
- One-Year Overall Survival Rate (1Y-OS)(1 year after enrollment.)
- Time to Progression (TTP)(From enrollment until the first documented disease progression or the end of study follow-up, up to 18 months.)
- Objective Response Rate (ORR)(From enrollment until disease progression, initiation of new anti-tumor therapy, death, or the end of study follow-up, up to 18 months.)
- Duration of Response (DOR) Based on mRECIST(From first documented response until disease progression, death, or the end of study follow-up, up to 18 months.)
- Disease Control Rate (DCR) Based on mRECIST(From enrollment until disease progression, initiation of new anti-tumor therapy, death, or the end of study follow-up, up to 18 months.)
- Pharmacokinetic characterization of maximum observed plasma concentration (Cmax) of GKL-006(From 60 minutes before the first dose through 60 days.)
- Pharmacokinetic characterization of time to maximum observed plasma concentration (Tmax) of GKL-006(From 60 minutes before the first dose through 60 days.)
- Pharmacokinetic characterization of area under the plasma concentration-time curve (AUC) of GKL-006(From 60 minutes before the first dose through 60 days.)
- Pharmacokinetic characterization of terminal elimination half-life (t½) of GKL-006(From 60 minutes before the first dose through 60 days.)
- Pharmacodynamic Biomarkers of NK cells(From 60 minutes before the first dose through 60 days.)
- Pharmacodynamic Biomarkers of T cells(From 60 minutes before the first dose through 60 days.)