A Phase 1 Study of AWT020 in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Adverse Events (AEs) [Safety]
研究概览
简要总结
This study is aimed at establishing the MTD and/or the RP2D for AWT020 monotherapy and to provide safety, tolerability, efficacy, PK, immunogenicity characteristics of AWT020.
详细描述
This study will enroll participants who have undergone at least one systemic therapy and have progressive disease during or after most recent line of therapy, and for whom no further standard therapy (that is known to confer clinical benefit) is available, or who are intolerant of standard therapy. The study design consists of two parts: dose escalation (BOIN design) and dose optimization. Participants enrolled into this study will be assigned to one of 4 dose levels and will 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
- •Age 18 years or older; able to provide written informed consent and comply with study visits and procedures.
- •Pathologically confirmed, unresectable advanced solid tumor.
- •Disease progression after at least one systemic therapy, with no beneficial standard option available or tolerated. Disease-specific prior therapy requirements apply to urothelial and renal cell carcinoma cohorts.
- •At least one measurable lesion by RECIST version 1.1, ECOG performance status of 0 or 1, and life expectancy of at least 3 months.
- •Adequate bone marrow, renal, hepatic, coagulation, and cardiac function as defined in the protocol.
- •Meets protocol requirements for reproductive safety and tumor tissue availability.
排除标准
- •Relevant hypersensitivity or intolerance to prior immunotherapy, interleukin-2 based therapy, monoclonal antibodies, or the study treatment; or prior immunotherapy discontinued because of an immune-related adverse event.
- •Untreated or unstable central nervous system metastases, leptomeningeal disease, or brainstem metastases.
- •Clinically significant autoimmune or skin disease requiring systemic treatment; Stevens-Johnson syndrome or toxic epidermal necrolysis; or current, suspected, or steroid-treated interstitial lung disease/pneumonitis.
- •Unresolved toxicity from prior therapy, or recent anticancer treatment, major surgery, live vaccine, or other restricted therapy within protocol-defined washout periods.
- •Clinically significant cardiac, thromboembolic, cerebrovascular, gastrointestinal, bleeding, or other uncontrolled medical condition.
- •Active or recent severe infection.
- •Prior allogeneic transplantation or adoptive cellular immunotherapy; concurrent investigational therapeutic trial; or pregnancy or breastfeeding.
- •Another malignancy within 5 years, except permitted low-risk or in situ cancers; or any condition that increases risk, prevents consent or compliance, or could interfere with study interpretation.
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
Adverse Events (AEs) [Safety]
时间窗: Throughout the study up to 30 months
Type, incidence, and severity of Adverse Events (AEs)
Serious Adverse Events (SAEs) [Safety]
时间窗: Throughout the study up to 30 months
Type, incidence, and severity of Serious Adverse Events (SAEs)
Treatment-emergent Adverse Events (TEAEs) [Safety]
时间窗: Throughout the study up to 30 months
Type, incidence, and severity of treatment-emergent adverse events (TEAEs)
Adverse Events of Special Interest (AESIs) [Safety]
时间窗: Throughout the study up to 30 months
Type, incidence, and severity of adverse events of special interest (AESIs)
Dose-limiting Toxicities (DLTs) [Tolerability]
时间窗: Throughout the study up to 30 months
Incidence of dose-limiting toxicity (DLT)
次要结局
- Maximum Observed Serum Concentration (Cmax)(Throughout the study up to 30 months)
- Time to Cmax (Tmax)(Throughout study up to 30 months)
- Area Under the Curve (AUC)(Throughout the study up to 30 months)
- Clearance (CL)(Throughout the study up to 30 months)
- Volume of Distribution (Vss)(Throughout the study up to 30 months)
- Half-life (t1/2)(Throughout the study up to 30 months)
- Overall Response Rate (ORR)(Throughout study up to 30 months)
- Disease Control Rate (DCR)(Throughout the study up to 30 months)
- Progression-free Survival (PFS)(Throughout the study up to 30 months)
- Immune-related ORR (iORR)(Throughout the study up to 30 months)
- Immune-related DCR (iDCR)(Throughout the study up to 30 months)
- Immune-related PFS (iPFS)(Throughout the study up to 30 months)
- Immune-related TTR (iTTR)(Throughout the study up to 30 months)
- Immune-related DOR (iDOR)(Throughout the study up to 30 months)
- Overall Survival(Throughout study up to 30 months)
- Immunogenicity of AWT020(Throughout study up to 30 months)