NCT07479485招募中1 期
An Open-Label, Multicenter, Phase I/II Study Evaluating MRG006A in Combination With Immune Checkpoint Inhibitors and Targeted Therapy in Patients With Advanced Hepatocellular Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 12
- 主要终点
- Adverse events
研究概览
简要总结
This is an open-label, multicenter, Phase I/II clinical study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of MRG006A in combination with immune checkpoint inhibitors and targeted therapy in patients with advanced hepatocellular carcinoma (HCC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Able to understand and provide written informed consent, and comply with the requirements specified in the protocol.
- •Life expectancy ≥ 3 months.
- •Must provide tumor tissue specimens for GPC3 testing.
- •Histologically/cytologically confirmed hepatocellular carcinoma (HCC), Barcelona Clinic Liver Cancer (BCLC) Stage C or Stage B not amenable to curative surgery and/or locoregional therapy.
- •At least one measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and modified RECIST (mRECIST).
- •No prior systemic antineoplastic therapy for unresectable HCC before first dose administration.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with no deterioration within 2 weeks prior to first study drug administration.
- •Adequate organ function as specified.
- •Negative serum pregnancy test within 7 days prior to first dose (women of childbearing potential). Pregnant or lactating women are not eligible for this study.
- •Women of childbearing potential and male patients must agree to use adequate contraception during MRG006A treatment and for 180 days after the last infusion.
排除标准
- •Prior histologically/cytologically confirmed diagnosis of hepatocellular carcinoma with fibrolamellar, sarcomatoid, cholangiocarcinoma, or other components.
- •History of hepatic failure or hepatic encephalopathy, or history of liver transplantation.
- •Pleural effusion, ascites, or pelvic effusion, or clinically significant pericardial effusion.
- •Acute or chronic active hepatitis B or hepatitis C infection.
- •Central nervous system metastases.
- •Prior locoregional therapy for hepatocellular carcinoma within 4 weeks before first dose administration.
- •Receipt of live attenuated vaccines within 4 weeks before first dose or planned administration during the study period.
- •Major surgical procedure within 4 weeks before first dose, or the presence of unhealed wounds, ulcers, or bone fractures.
- •Uncontrolled or poorly controlled medical conditions.
- •Toxicities from prior therapy that have not resolved to Grade 0 or 1 before first dose of study treatment.
- •Severe cardiac insufficiency or cerebrovascular events within 6 months prior, or occurrence of pulmonary embolism, deep vein thrombosis, gastrointestinal perforation and/or fistula, or intestinal obstruction.
- •Patients with double or multiple primary malignancies.
- •Hypersensitivity to any component or excipient of the investigational product.
- •Active or poorly controlled severe infection.
- •Any severe and/or uncontrolled systemic disease that, in the opinion of the investigator and sponsor, renders the patient unsuitable for participation in this study.
研究组 & 干预措施
MRG006A+ PD1/VEGF antibody
Experimental
干预措施: PD1/VEGF antibody (Drug)
MRG006A+ TKI
Experimental
干预措施: TKI (Drug)
MRG006A+Pucotenlimab + Bevacizumab
Experimental
干预措施: Pucotenlimab (Drug)
MRG006A+Pucotenlimab + Bevacizumab
Experimental
干预措施: Bevacizumab (Drug)
MRG006A+Pucotenlimab + Bevacizumab
Experimental
干预措施: MRG006A (Drug)
MRG006A+ PD1/VEGF antibody
Experimental
干预措施: MRG006A (Drug)
MRG006A+ TKI
Experimental
干预措施: MRG006A (Drug)
结局指标
主要结局
Adverse events
时间窗: Up to 2 years
Proportion of participants experiencing treatment-related adverse events as assessed by CTCAE v5.0
Recommended Phase 2 Dose
时间窗: 1 year
Evaluate RP2D based on the safety and efficacy of different dosage cohorts.
次要结局
- Peak concentration (Cmax)(Up to 2 years)
- Time to peak (Tmax)(Up to 2 years)
- Area under the concentration versus time curve (AUC)(Up to 2 years)
- Half-life time (t1/2)(Up to 2 years)
- Anti-Drug Antibody characteristics(Up to 2 years)
- Objective Response Rate(6 months)
- Disease Control Rate(6 months)
- Duration of Response(Up to 2 years)
- Progression-Free Survival(Up to 2 years)
研究者
研究点 (12)
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