NCT06084884进行中（未招募）1 期
A Phase I/II Open-Label Study to Evaluate the Safety, Cellular Kinetics and Efficacy of AZD5851, a Chimeric Antigen Receptor T-Cell (CAR-T) Therapy Directed Against GPC3 in Adult Participants With Advanced/Recurrent Hepatocellular Carcinoma: ATHENA
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 94
- 试验地点
- 20
- 主要终点
- 1. Incidence of participants with dose-limiting toxicities (DLTs), adverse events (AEs), including adverse events of special interest (AESI) and serious adverse events (SAEs). Determination of the recommended dose of AZD5851 for expansion phase
研究概览
简要总结
A Phase I/II study to evaluate AZD5851 in patients with GPC3+ advanced/recurrent hepatocellular carcinoma.
详细描述
This first-time in human, single-arm, open-label multicentre Phase I/II study will evaluate the safety, tolerability, antitumour activity, cellular kinetics, pharmacodynamics, and immunogenicity of AZD5851 in adult participants with GPC3+ advanced/recurrent HCC, where at least one line of prior therapy has failed/or was intolerable, or participant/investigator decision.
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
盲法说明
Open-label
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be 18 years or older and has voluntarily agreed to participate by giving written informed consent.
- •Participants with confirmed advanced/recurrent or metastatic and/or unresectable HCC based on histopathological findings
- •Completed or were unable to tolerate at least one prior line of standard systemic therapy for HCC and/or participant/investigator decision.
- •GPC3-positive tumour as determined by a central laboratory using an analytically validated IHC assay
- •Barcelona Clinic Liver Cancer Stage B (if not amenable to local treatment/surgery) or C prior to apheresis
- •Child-Pugh score: Grade A
- •Participants with HBV and HCV undergoing management of these infections per institutional practice.
排除标准
- •Active or prior documented gastrointestinal (GI) variceal bleed or history of upper GI bleeding, ulcers, or esophageal varices with bleeding within 12 months
- •History of liver transplantation or on waiting list
- •Current clinically significant ascites
- •Main portal vein thrombus, or tumor thrombus invasion of mesenteric vein / inferior vena cava
- •Uncontrolled intercurrent illness
- •Active Infections
- •Positive serology for HIV
- •History of hepatic encephalopathy within 12 months prior to treatment allocation
- •History of chronic or recurrent (within the last year) severe autoimmune or immune mediated disease requiring steroids or other immune-suppressive treatments.
- •Prior treatment with any CAR-T therapy directed at any target or any therapy that is targeted to GPC
- •Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumour embolisation, or monoclonal antibodies, investigational product) within 5 half-lives or ≤ 21 days (whichever is shortest).
研究组 & 干预措施
AZD5851
Experimental
Subjects will receive AZD5851 following 3 consecutive doses of lymphodepleting chemotherapy (fludarabine and cyclophosphamide).
干预措施: AZD5851 (Biological)
结局指标
主要结局
1. Incidence of participants with dose-limiting toxicities (DLTs), adverse events (AEs), including adverse events of special interest (AESI) and serious adverse events (SAEs). Determination of the recommended dose of AZD5851 for expansion phase
时间窗: Through study completion, an average of 2 years
Determine if treatment with AZD5851 is safe and tolerable through assessment of DLTs, AEs, SAEs and changes from baseline in vital signs, ECGs, and laboratory parameters
次要结局
- 2. Interval between the date of AZD5851 infusion dose and first documented evidence of CR or PR(Through study completion, an average of 2 years)
- 3. Proportion of participants who have a confirmed CR, PR, or who have stable disease (SD) for at least 5 weeks after the date of AZD5851 infusion(Through study completion, an average of 2 years)
- 5. The best response the participant achieved according to RECIST v1.1(Through study completion, an average of 2 years)
- 10. Pharmacokinetics -time to peak serum concentration of AZD5851(Through study completion, an average of 2 years)
- 6. Interval between the date of first documented objective response date of first documented disease progression or the last evaluable assessment in the absence of progression(Through study completion, an average of 2 years)
- 9. Pharmacokinetics - maximum serum concentration of AZD5851(Through study completion, an average of 2 years)
- 12. Pharmacokinetics - Exposure of AZD5851(Through study completion, an average of 2 years)
- 4. The proportion of participants who have a confirmed response (CR/PR) with a duration of at least a specific number of months(Through study completion, an average of 2 years)
- 7. Interval between the date of first T cell infusion and the earliest date of disease progression or death due to any cause(Through study completion, an average of 2 years)
- 8. Interval between the date of first T cell infusion and date of death due to any cause(Through study completion, an average of 2 years)
- 1. Proportion of participants with a confirmed Complete Response (CR) or Partial Response (PR)(Through study completion, an average of 2 years)
- 11. Pharmacokinetics -time to last measurable serum concentration of AZD5851(Through study completion, an average of 2 years)
研究者
研究点 (20)
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