NCT05178043进行中（未招募）2 期
A Phase II Study to Evaluate the Efficacy and Safety of GT90001 in Combination With Nivolumab as a Second-line Treatment in Subjects With Advanced Hepatocellular Carcinoma
Suzhou Kintor Pharmaceutical Inc,5 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2021年8月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 5
- 试验地点
- 5
- 主要终点
- The Objective Response Rate (ORR) (confirmed) as evaluated by an Independent Review Committee (IRC) according to RECIST v1.1
研究概览
简要总结
This is a global phase II, open label study in the subjects with Advanced Hepatocellular Carcinoma (aHCC) who were intolerant or had progressed after or intolerant to first-line Immune Checkpoint Inhibitors (ICI) such as Atezolizumab plus Bevacizumab, or ICI plus Tyrosine Kinase Inhibitor (TKI).
Based on published and first-hand experience with the safety and tolerability of both GT90001 and Nivolumab, the proposed dose is GT90001 7 mg/kg in combination with Nivolumab 240 mg, infusion every two weeks.
This study will enroll a total of 105 subjects to receive combinational therapy of Nivolumab and GT90001.
• Nivolumab 240 mg will first be administered by intravenous infusion over 30 minutes, then 30 minutes later, give intravenous infusion of GT90001 7.0 mg/kg over 60 min, once every two weeks.
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
- •Subjects must have confirmed diagnosis of aHCC (locally advanced or metastatic hepatocellular carcinoma) by radiography, histology and/or cytology, not eligible for surgical and/or locoregional therapies; or progressive disease after surgical and/or locoregional therapies (fibrolamellar, sarcomatoid HCC and mixed hepatocellular / cholangiocarcinoma subtypes are not eligible);
- •Have Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy;
- •Have documented disease progression after or intolerance to first line treatment of immune checkpoint inhibitors(ICI)
- •Child-Pugh score ≤ 6 (Child-Pugh A) score within 7 days of first dose of study drug;
- •ECOG performance status: 0-1 within 7 days of first dose of study drug;
- •Have a predicted life expectancy of greater than 3 months;
- •Adequate hematologic and end-organ function functions of the important organs are confirmed.
排除标准
- •Presence of tumor thrombus involving main trunk of portal vein (Vp4), inferior vena cava, cardiac involvement of HCC;
- •Subjects with untreated or incompletely treated varices with bleeding or high-risk for bleeding. Has had esophageal or gastric variceal bleeding within the last 6 months;
- •History of encephalopathy;
- •Has a known history of, or any evidence of central nervous system (CNS) metastases and/or carcinomatous meningitis;
- •Had history of a solid organ or hematologic transplant;
- •Has received locoregional therapy to liver (TACE, TAE, hepatic arterial infusion [HAI], radiation, radioembolization or ablation) within 4 weeks of start of study treatment.
- •Had prior systemic TKI treatment prior to start of study treatment;
- •Has received prior immune checkpoint inhibitors within 4 weeks of start of study treatment;
- •Has received Nivolumab in the first-line systemic therapy:
- •Active co-infection with:
- •Both hepatitis B and C as evidenced by positive HBV surface antigen or detectable HBV DNA and HCV RNA, OR
- •Hepatitis D infection in subjects with hepatitis B
- •Has an active bacterial or fungal infection requiring systemic therapy within 7 days prior to study drug dosing;
- •Has a known history of active tuberculosis (Bacillus Tuberculosis);
- •Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture;
- •Thrombotic or embolic events (except HCC tumor thrombus) within the past 6 months, such as cerebrovascular accident (including transient ischemic attacks), pulmonary embolism; If prior history of deep vein thrombosis (DVT) / (pulmonary embolism (PE), the subject needs to be on stable doses of anticoagulation with low molecular weight heparin or oral anticoagulant for at least two weeks;
- •Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- •Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis;
- •Subjects with any other serious disease considered by the investigator not in the condition to enter into the trial;
研究组 & 干预措施
GT90001+Nivolumab
Experimental
干预措施: Nivolumab (Drug)
GT90001+Nivolumab
Experimental
干预措施: GT90001 (Drug)
结局指标
主要结局
The Objective Response Rate (ORR) (confirmed) as evaluated by an Independent Review Committee (IRC) according to RECIST v1.1
时间窗: Approximately 2 years
ORR is defined as the proportion of participants with best overall response of confirmed complete response (CR) or partial response (PR). RECIST: Response Evaluation Criteria in Solid Tumors
次要结局
- DOR as evaluated by an IRC according to HCC mRECIST(Approximately 2 years)
- PFS as evaluated by an IRC according to HCC mRECIST(Approximately 2 years)
- Time To Response (TTR) as evaluated by an IRC according to RECIST v1.1(Approximately 2 years)
- DOR as evaluated by the investigator according to RECIST v1.1(Approximately 2 years)
- PFS as evaluated by the investigator according to RECIST v1.1(Approximately 2 years)
- TTP as evaluated by the investigator according to RECIST v1.1(Approximately 2 years)
- ORR (confirmed) as evaluated by an IRC according to HCC mRECIST(Approximately 2 years)
- TTR as evaluated by an IRC according to HCC mRECIST(Approximately 2 years)
- TTP as evaluated by an IRC according to HCC mRECIST(Approximately 2 years)
- DCR as evaluated by an IRC according to HCC mRECIST(Approximately 2 years)
- DCR as evaluated by the investigator according to RECIST v1.1(Approximately 2 years)
- Duration OF Response (DOR) as evaluated by an IRC according to RECIST v1.1(Approximately 2 years)
- Disease Control Rate (DCR) as evaluated by an IRC according to RECIST v1.1(Approximately 2 years)
- TTR as evaluated by the investigator according to HCC mRECIST(Approximately 2 years)
- DOR as evaluated by the investigator according to HCC mRECIST(Approximately 2 years)
- Presence of Anti-Drug Antibodies (ADAs) to GT90001 and Nivolumab during the study relative to the presence of ADAs at baseline(Approximately 2 years)
- Time to Progression (TTP) as evaluated by an IRC according to RECIST v1.1(Approximately 2 years)
- ORR (confirmed) as evaluated by the investigator according to RECIST v1.1(Approximately 2 years)
- ORR (confirmed) as evaluated by the investigator according to HCC mRECIST(Approximately 2 years)
- Progression Free Survival (PFS) as evaluated by an IRC according to RECIST v1.1(Approximately 2 years)
- TTR as evaluated by the investigator according to RECIST v1.1(Approximately 2 years)
- PFS as evaluated by the investigator according to HCC mRECIST(Approximately 2 years)
- Overall survival (OS)(Approximately 3 years)
- TTP as evaluated by the investigator according to HCC mRECIST(Approximately 2 years)
- DCR as evaluated by the investigator according to HCC mRECIST(Approximately 2 years)
- Safety and tolerability (any Advense Events (AEs), Severe AEs , immune-related AEs (irAEs), treatment-related AEs, abnormal laboratory values, etc.(Approximately 2 years)
研究者
研究点 (5)
Loading locations...
相似试验
尚未招募
2 期
HLX07 Combination Therapy or Motherapy in Patient With Advanced Hepatocellular CarcinomaAdvanced Hepatocellular CarcinomaNCT05290220Shanghai Henlius Biotech60
已完成
2 期
Radomised Phase II Study of MTL-CEBPA Plus Sorafenib or Sorafenib AloneHepatocellular CarcinomaHepatitis CHepatitis BNCT04710641Mina Alpha Limited8
进行中（未招募）
2 期
Study to Evaluate Adverse Events, and Change in Disease Activity, When Intravenously (IV) Infused With Livmoniplimab in Combination With IV Infused Budigalimab in Adult Participants With Hepatocellular Carcinoma (HCC)Hepatocellular CarcinomaNCT05822752AbbVie120
进行中（未招募）
1 期
A Study to Assess the Adverse Events and How Intravenously Infused Livmoniplimab in Combination With Budigalimab Moves Through the Bodies of Adult Chinese Participants With Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC)Hepatocellular Carcinoma (HCC)NCT06487559AbbVie3
终止
2 期
KN046 in Patients With Advanced Non-small Cell Lung CancerStage IV Non-small Cell Lung CancerNCT03838848Jiangsu Alphamab Biopharmaceuticals Co., Ltd120