A Phase 1/2, First-in-human, Open-label Study of Single-agent AWT020 in Patients With Progressive Locally Advanced or Metastatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE 5.0
研究概览
简要总结
The aims of this clinical trial are (1) to assess the safety of AWT020 at different dose levels; (2) to determine the pharmacokinetics and pharmacodynamics of AWT020 in subjects with locally advanced or metastatic cancer who have failed standard therapy.
详细描述
This study will enroll subjects with locally advanced or metastatic cancer who have failed standard therapy. Subjects enrolled into this study will be assigned a dose level and receive AWT020 via intravenous infusion at a regular interval. The treatment will be continued until disease progression, withdrawal from study or death. The primary objective is to investigate the safety of this agent. The secondary objective is to investigate the pharmacokinetics, pharmacodynamic, potential anti-tumor activity and immunogenicity of this agent.
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
- •Subject has provided informed consent prior to initiation of any study specific activities or procedures.
- •Subject must be ≥ 18 years of age or per local regulation.
- •Subjects must have a histological diagnosis of solid tumors (carcinoma or sarcoma) or malignant lymphoma, either progressive locally advanced not amenable to local therapy or metastatic, which is refractory, ineligible (in the opinion of the Investigator) or intolerant to standard therapy. Subjects with hepatocellular carcinoma must be diagnosed with dynamic CT or MRI if no tissue diagnosis is available.
- •Subject must have performance status of 0, or 1 on the ECOG performance scale.
- •Subject with adequate organ function.
- •Life expectancy is longer than three months.
- •Subject must be able to receive effective contraceptive measures.
排除标准
- •Subject is allergic or intolerant to either anti-PD1 or interleukin-2 therapy.
- •Subject has received prior immune-check point inhibitors and was discontinued due to greater than grade 3 toxicities.
- •Subject is receiving other investigational agent or device.
- •Subject has active infection, uncontrolled hypertension, unstable angina, uncontrolled diabetes mellitus, recent myocardial infarction, and congestive heart failure with ejection fraction less than 50%.
- •Subject has prior allogeneic stem cell or bone marrow transplant or organ transplant.
- •Subject has active central nervous system (CNS) metastases or carcinomatous meningitis.
- •Subject with HIV whose viral load is > 400 copies/mL or CD4+ T cell counts are < 350 cells/µL.
- •Subject has baseline corrected QT interval (QTc) longer than 480 ms by Fridericia formula.
- •Subject is pregnant or breast-feeding.
- •Subject has received live virus vaccine within 28 days prior to the first dose of study.
- •Any other conditions that might compromise the safety of the subject or the integrity of the study.
研究组 & 干预措施
AWT020
Participants receiving intravenous infusion of AWT020
干预措施: AWT020 (Biological)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE 5.0
时间窗: From the first infusion up to 90 days after last infusion
The overall safety of AWT020 in treated subjects
次要结局
- Cmax of AWT020(30 minutes after the first infusion in cycle 1 and cycle 2)
- Overall survival in the overall population(5 years)
- Area under the serum concentration versus time curve (AUC) of AWT020(First infusion to the end of week 2)
- Half-life of AWT020(First infusion to the end of week 2)
- Immunogenicity of AWT020(Baseline to Cycle 7 Day 1 (each cycle is 28 days))
- Overall response rate in the overall population(During treatment period, an average of 6 months)
- Disease control rate in the overall population(During treatment period, an average of 6 months)
- Progression-free survival in the overall population(2 years)