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
- 已完成
- 发起方
- Abivax S.A.
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Incidence and Severity 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
The goal of this clinical trial is to investigate if ABX196 in combination with nivolumab can benefit adult patients with hepatocellular carcinoma.
研究设计
- 研究类型
- 干预性
- 分配方式
- 不适用
- 干预模型
- 序贯
- 主要目的
- 治疗
- 盲法
- 开放（无盲法）
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 who are intolerant to or who progressed on at least one line of Tyrosine Kinase Inhibitor (TKI) and/or Checkpoint inhibitor (CPI) therapy
- Patients eligible to be treated with nivolumab or under treatment 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
- Patients with adequate organ function at screening
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
- Patients treated with an investigational drug 2 weeks before first study dose
研究组 & 干预措施
Dose Escalation for ABX196
Dose escalation: ABX196 at 0.1, 0.2, or 0.4 µg i.m. was administered after completion of nivolumab infusion on Day 1 of every other 28-day treatment cycle (i.e., every 8 weeks). Nivolumab 240 mg i.v. was administered on Days 1 and 15 of each 28-day cycle.
干预措施: ABX196 (Drug)
方案终点
主要结局
Incidence and Severity of Adverse Events (AEs)
时间窗: From first day of treatment (randomization visit) up to 64 weeks of treatment + up to 30 days of safety follow-up (total: up to 478 days)
Incidence and severity of adverse events evaluated according to CTC-AE
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 first dose of treatment (randomization visit) up to 64 weeks treatment)
- Progression Free Survival (PFS)(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 64 weeks)
- Time to Progression (TTP)(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 64 weeks)
- Change in Alpha Fetoprotein Serum(From first dose of treatment (randomization visit) up to 64 weeks treatment)
- 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)
试验结果
结果已于 2026-09-29 在 ClinicalTrials.gov 公示。 在 ClinicalTrials.gov 查看
受试者流程
入组 10 人 · 完成 5 人
主要终点
Incidence and Severity of Adverse Events (AEs)
Participants · 时间窗: From first day of treatment (randomization visit) up to 64 weeks of treatment + up to 30 days of safety follow-up (total: up to 478 days)
| 分类 | ABX196 0.1 µg i.m. （n=4） | ABX196 0.2 µg i.m. （n=2） | ABX196 0.4 µg i.m. （n=3） |
|---|---|---|---|
| Any TEAE, n (%) | 4 | 2 | 3 |
| Any Serious TEAE, n (%) | 1 | 0 | 0 |
| Any ABX196-related TEAE, n (%) | 2 | 2 | 0 |
| Any nivolumab-related TEAE, n (%) | 3 | 2 | 0 |
| Any serious ABX196-related TEAE, n (%) | 0 | 0 | 0 |
| Any serious nivolumab-related TEAE, n (%) | 0 | 0 | 0 |
其他终点（4）
Objective Response Rate (ORR)
Participants · 时间窗: From first dose of treatment (randomization visit) up to 64 weeks treatment
| 分类 | ABX196 0.1 µg i.m. （n=4） | ABX196 0.2 µg i.m. （n=3） | ABX196 0.4 µg i.m. （n=3） |
|---|---|---|---|
| Objective Response Rate (ORR) | 1 | 0 | 0 |
| Complete Response Rate (CR) | 0 | 0 | 0 |
| Partial Response Rate (PR) | 1 | 0 | 0 |
Progression Free Survival (PFS)
Days · 90% Confidence Interval · 时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 64 weeks
| ABX196 0.1 µg i.m. （n=4） | ABX196 0.2 µg i.m. （n=3） | ABX196 0.4 µg i.m. （n=3） |
|---|---|---|
| 340.5 (44–NA) | 56 (53–NA) | 56 (56–NA) |
ABX196 0.1 µg i.m.: The upper confidence interval is reported as NA because the confidence curve does not provide a valid upper crossing before the end of follow-up when the number of subjects remaining at risk is too small. Under these circumstances, SAS is unable to estimate a valid upper confidence limit.
ABX196 0.2 µg i.m.: The upper confidence interval is reported as NA because the confidence curve does not provide a valid upper crossing before the end of follow-up when the number of subjects remaining at risk is too small. Under these circumstances, SAS is unable to estimate a valid upper confidence limit.
ABX196 0.4 µg i.m.: The upper confidence interval is reported as NA because the confidence curve does not provide a valid upper crossing before the end of follow-up when the number of subjects remaining at risk is too small. Under these circumstances, SAS is unable to estimate a valid upper confidence limit.
Time to Progression (TTP)
Days · 90% Confidence Interval · 时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 64 weeks
| ABX196 0.1 µg i.m. （n=4） | ABX196 0.2 µg i.m. （n=3） | ABX196 0.4 µg i.m. （n=3） |
|---|---|---|
| 340.5 (44–NA) | 56 (53–NA) | 56 (56–NA) |
ABX196 0.1 µg i.m.: The upper confidence interval is reported as NA because the confidence curve does not provide a valid upper crossing before the end of follow-up when the number of subjects remaining at risk is too small. Under these circumstances, SAS is unable to estimate a valid upper confidence limit.
ABX196 0.2 µg i.m.: The upper confidence interval is reported as NA because the confidence curve does not provide a valid upper crossing before the end of follow-up when the number of subjects remaining at risk is too small. Under these circumstances, SAS is unable to estimate a valid upper confidence limit.
ABX196 0.4 µg i.m.: The upper confidence interval is reported as NA because the confidence curve does not provide a valid upper crossing before the end of follow-up when the number of subjects remaining at risk is too small. Under these circumstances, SAS is unable to estimate a valid upper confidence limit.
Change in Alpha Fetoprotein Serum
Participants · 时间窗: From first dose of treatment (randomization visit) up to 64 weeks treatment
| 分类 | ABX196 0.1 µg i.m. （n=4） | ABX196 0.2 µg i.m. （n=0） | ABX196 0.4 µg i.m. （n=2） |
|---|---|---|---|
| Cycle 1 Day 1 AFP Responders, n (%) | 0 | — | 0 |
| Cycle 1 Day 15 AFP Responders, n (%) | 0 | — | — |
| Cycle 2 Day 1 AFP Responders, n (%) | 0 | — | 0 |
| Cycle 3 Day 1 AFP Responders, n (%) | 1 | — | 0 |
| Cycle 4 Day 1 AFP Responders, n (%) | 1 | — | 0 |
| Cycle 5 Day 1 AFP Responders, n (%) | 1 | — | 0 |
| Cycle 6 Day 1 AFP Responders, n (%) | 1 | — | 0 |
| Cycle 7 Day 1 AFP Responders, n (%) | 1 | — | 0 |
| Cycle 8 Day 1 AFP Responders, n (%) | 1 | — | — |
| Cycle 9 Day 1 AFP Responders, n (%) | 1 | — | — |
| Cycle 10 Day 1 AFP Responders, n (%) | 1 | — | — |
| Cycle 11 Day 1 AFP Responders, n (%) | 1 | — | — |
| Cycle 12 Day 1 AFP Responders, n (%) | 1 | — | — |
| Cycle 13 Day 1 AFP Responders, n (%) | 1 | — | — |
| Cycle 14 Day 1 AFP Responders, n (%) | 1 | — | — |
| Cycle 15 Day 1 AFP Responders, n (%) | 1 | — | — |
| Cycle 16 Day 1 AFP Responders, n (%) | 0 | — | — |
| Termination AFP Responders, n (%) | 1 | — | 0 |
A single patient (0.1 µg) exhibited an AFP response
安全性
| 组别 | 严重不良事件 | 死亡 |
|---|---|---|
| ABX196 0.1 µg | 1 / 4 | 0 / 4 |
| ABX196 0.2 µg | 0 / 3 | 0 / 3 |
| ABX196 0.4 µg | 0 / 3 | 0 / 3 |
最常见的严重不良事件（人数）
| 事件 | ABX196 0.1 µg | ABX196 0.2 µg | ABX196 0.4 µg |
|---|---|---|---|
| Cellulitis | 1 / 4 | 0 / 3 | 0 / 3 |
数值为申办方在 ClinicalTrials.gov 公示的原始数据，未经重新计算；括号内为公示的离散度（如 95% 置信区间）。
研究者
研究点 (4)
标识符
- NCT 编号
- NCT03897543
- 其他研究编号
- ABX196-001
日期
- 首次提交
- (7年前)
- 首次发布
- (7年前)
- 主要完成日期
- (4年前)
- 研究完成日期
- (4年前)
- 最近核实
- (2个月前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 是
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 是