A Phase 1-2 Study of ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Abivax S.A.
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Incidence of adverse events (AEs)
研究概览
简要总结
Open-label, uncontrolled, phase 1-2 study to evaluate the safety, tolerability, pharmacodynamic effects, and preliminary efficacy of ABX196 administered in combination with nivolumab in patients with hepatocellular carcinoma
详细描述
This is an open-label, uncontrolled phase 1-2 study to evaluate the safety, tolerability, pharmacodynamic effects, and preliminary efficacy of ABX196 administered in combination with nivolumab in patients with hepatocellular carcinoma. The study consists of 2 phases, a Dose Escalation Phase and an Expansion Phase. Nivolumab will be administered, consistent with the US prescribing information, as a 30-minute IV infusion on Days 1 and 15 of each 28-Day cycle. ABX196 will be administered as an IM injection 120 minutes (+/- 15 minutes) after the completion of the nivolumab infusion on Day 1 of every other 28-Day cycle (i.e., every 8 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
- •Men or women, Age ≥18 years
- •Patients with ECOG performance status 0 or 1
- •Patients with histologically confirmed diagnosis of HCC not amenable to curative surgery or local therapy
- •Patients with documented objective radiographic progression during or after local therapy or after treatment with sorafenib or lenvatinib or intolerance to or refusal to receive either agent
- •Patients with at least one prior systemic therapy for HCC
- •Patients eligible to be treated with nivolumab
- •Patients with measurable disease based on RECIST v1.1
- •Patients with Child-Pugh class A liver score within 7 days of first study dose
- •Patients with no history of hepatic encephalopathy
- •Patients with no prior or current clinically significant ascites as measured by physical examination and that requires active paracentesis for control (patients with ascites only on radiographic imaging are eligible)
- •Patients with HBV infection must have received antiviral therapy for at least 12 weeks and HBV viral load must be documented to be <100 IU/mL within 7 days of first study dose
- •Patients with no active co-infection with HBV and HCV or HBV and HDV
- •Patients with no active drug or alcohol abuse
排除标准
- •Patients with tyrosine kinase inhibitor treatment within 2 weeks of first study dose
- •Patients with esophageal or gastric variceal bleeding within the past 6 months
- •Patients with portal vein invasion at the main portal (Vp4) or the inferior vena cava or cardiac involvement of HCC based on imaging
- •Patients with previous solid organ or hematologic transplantation
- •Patients with active autoimmune disease requiring systemic treatment in the past 2 years
- •Patients with diagnosis of immunodeficiency or receiving systemic steroid therapy or other immunosuppressive therapy within 7 days before first study dose
- •Patients with previous locoregional therapy or major surgery to the liver within 6 weeks before first study dose
- •Patients with minor surgery to liver or another site within 1 week before first study dose
研究组 & 干预措施
ABX196
IM injection of 0.1, 0.2, and 0.4 µg of ABX196
干预措施: ABX196 (Drug)
结局指标
主要结局
Incidence of adverse events (AEs)
时间窗: Through study completion, an average of 1 year
Adverse Events evaluated according to CTC-AE
次要结局
- Objective Response Rate (ORR)(From date of randomization until the date of first documented progression, assessed up to 12 months)
- Progression-Free Survival(From date of randomization until the date of first documented progression, assessed up to 24 months)
- Alpha Fetoprotein Serum concentrations(Every 2 weeks, assessed up to 12 months)
- Duration of Response (DOR)(From date of randomization until the date of first documented progression, assessed up to 12 months)