A Phase 1/2 Study of BMS-986183 in Subjects With Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 25
- 试验地点
- 5
- 主要终点
- Incidence of Adverse Events at Its Worst Grade
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of BMS-986183 in patients with liver cancer.
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
- •Must have advanced liver cancer that cannot be treated with surgery or other local methods
- •Liver cancer is confirmed by a microscopic examination of tissue
- •Liver disease is classified as 'A' by a standard method called Child-Pugh score
- •Daily living abilities are classified as '0 or 1' by a standard method from the Eastern Cooperative Oncology Group (ECOG)
- •Women must use contraception
排除标准
- •Prior liver transplant
- •Increase in blood pressure in some of the veins entering the liver
- •Cancer that has spread to the brain or the layers of tissue that cover the brain or spinal cord
- •Infection with both hepatitis B and C, both hepatitis D and B, infection with HIV, or other infections
- •Disease of the heart or blood vessels around the heart
- •Active cancers within the last 2 years
- •No more than 2 prior systemic treatments or other investigational agents except PD-1/PD-L1 or Ipilimumab (Part 2)
- •Currently on anti-platelet or anti-coagulation therapy
- •Radiotherapy within 4 weeks of treatment
- •Any major allergies
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
Dose Escalation Combination Therapy
干预措施: BMS-986183 (Biological)
Dose Escalation Monotherapy
干预措施: BMS-986183 (Biological)
Dose Expansion Combination Therapy
干预措施: Nivolumab (Biological)
Dose Expansion Monotherapy
干预措施: BMS-986183 (Biological)
Dose Expansion Combination Therapy
干预措施: BMS-986183 (Biological)
Dose Escalation Combination Therapy
干预措施: Nivolumab (Biological)
结局指标
主要结局
Incidence of Adverse Events at Its Worst Grade
时间窗: First dose up to approximately 24 months
Evaluated by comparing the incidence of Adverse Events (AEs) among subjects using their assigned treatment for at least one day.
Incidence of Adverse Events Leading to Discontinuation
时间窗: First dose up to approximately 24 months
Evaluated by comparing the incidence of Adverse Events leading to discontinuation among subjects using their assigned treatment for at least one day.
Incidence of Serious Adverse Events at Its Worst Grade
时间窗: First dose up to approximately 24 months
Evaluated by comparing the incidence of Serious Adverse Events (SAEs) among subjects using their assigned treatment for at least one day.
Incidence of Adverse Events Leading to Death
时间窗: First dose up to approximately 24 months
Evaluated by comparing the incidence of Adverse Events leading to death among subjects using their assigned treatment for at least one day.
Incidence of Laboratory Test Toxicity Grade Shifting From Baseline
时间窗: First dose up to approximately 24 months
次要结局
- Overall Response Rate (ORR)(First dose up to approximately 24 months)
- Time of Maximum Observed Concentration (Tmax)(First dose up to approximately 24 months)
- Area Under the Concentration-time Curve From Time 0 to T of the Last Quantifiable Concentration [AUC(0-T)](First does up to appromimately 24 months)
- Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)](First dose up to approximately 24 months)
- Best Overall Response (BOR)(First dose up to approximately 24 months)
- Duration of Response (DoR)(First dose up to approximately 24 months)
- Progression Free Survival (PFS)(First dose up to approximately 24 months)
- PFS Rate at Week 't'(First dose up to approximately 24 months)
- Maximum Observed Concentration (Cmax)(From first does up to approximately 24 months)
- Trough Observed Concentration, Including Predose Concentrations and Ctau (Ctrough)(First dose up to approximately 24 months)
- Total Body Clearance (CLT)(First dose to approximately 24 months)
- Concentration at the End of a Dosing Interval (Ctau)(First dose up to approximately 24 months)
- Apparent Volume of Distribution at Steady-state (Vss)(First dose up to approximately 24 months)
- Volume of Distribution of Terminal Phase (Vz)(First dose up to approximately 24 months)
- Accumulation Index; Ratio of Cmax at Steady-state to Cmax After the First Dose (AI_Cmax)(First dose up to approximately 24 months)
- Accumulation Index; Ratio of Ctau at Steady-state to Ctau After the First Dose (AI_Ctau)(First dose up to approximately 24 months)
- Accumulation Index; Ratio of AUC(TAU) at Steady-state to AUC(TAU) After the First Dose [AI_AUC(TAU)](First dose up to approximately 24 months)
- Average Concentration Over a Dosing Interval Calculated by Dividing AUC(TAU) at Steady State by Tau (Css,Ave)(First dose up to approximately 24 months)
- Terminal Half-life (T-HALF)(First dose up to approximately 24 months)
- Changes in QTcF (ΔQTcF) From Baseline(Baseline up to approximately 24 months)
- Incidence of Positive Anti-drug Antibody (ADA)(First dose up to approximately 24 months)