Phase 1/1b Study to Evaluate the Safety and Activity of TTX-030 (Anti-CD39) in Combination With Pembrolizumab or Budigalimab and/or Chemotherapy in Subjects With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 185
- 试验地点
- 60
- 主要终点
- Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
研究概览
简要总结
This is a phase 1/1b study of TTX-030 in combination therapy, an antibody that inhibits CD39 enzymatic activity, leading to accumulation of pro-inflammatory adenosine triphosphate (ATP) and reduction of immunosuppressive adenosine, which may change the tumor microenvironment and promote anti-tumor immune response.
This trial will study the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of TTX-030 in combination with immunotherapy and/or standard chemotherapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older, is willing and able to provide informed consent
- •Histologically confirmed diagnosis of unresectable or metastatic solid tumor malignancy in selected tumor types
- •Life expectancy > 12 weeks
- •ECOG performance status of 0-1
- •Abbreviated
排除标准
- •History of allergy or hypersensitivity to study treatment components. Patients with a history of severe hypersensitivity reaction to any monoclonal antibody.
- •Use of investigational agent within 28 days prior to the first dose of study treatment and throughout the study
- •Receiving high-dose systemic steroid therapy or any other form of immunosuppressive therapy
- •History of severe autoimmune disease
- •Uncontrolled intercurrent illness or other active malignancy requiring ongoing treatment
结局指标
主要结局
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
时间窗: 7 day load + 1 cycle (1 cycle is 28 days)
A DLT was defined as the occurrence of any of the following toxicities within the DLT Evaluation Period if judged by the Investigator and Sponsor to be possibly, probably, or definitely related to TTX-030 or budigalimab.
The Incident of Adverse Events
时间窗: Through study completion, an average of 1 year
Number of study subjects experiencing adverse events (AEs) and serious adverse events (SAEs). Safety profile will be assessed through laboratory evaluations, vital signs, and physical examinations.
次要结局
- Pharmacokinetics (PK)(Cycles 1-4 (each cycle is 21-28 days))
- Confirmed Objective Response Rate (ORR)(Through study completion, an average of 1 year)
- Best Response (BOR)(Through study completion, an average of 1 year)
- Duration of Response (DOR)(Through study completion, an average of 1 year)
- Disease Control Rate (DCR)(Through study completion, an average of 1 year)
- Progression-free Survival (PFS)(Through study completion, an average of 1 year)
- Pharmacokinetics (PK)(Cycles 1-4 (each cycle is 21-28 days))
- Overall Survival (OS)(Through study completion, an average of 1 year)