Phase 1/1b Study of the Safety of TTX-030 as a Single Agent and in Combination With Pembrolizumab or Chemotherapy in Patients With Lymphoma or Solid Tumor Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 16
- 主要终点
- Objective Response Rate (ORR) - Arm 1 and Arm 2 Expansion Cohorts
研究概览
简要总结
This is a phase 1/1b study of TTX-030, 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, and anti-tumor activity of TTX-030 as a single agent and in combination with an approved anti-PD-1 immunotherapy and standard chemotherapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm 1, Single Agent
TTX-030
干预措施: TTX-030 (Drug)
Arm 2, Anti-PD-1 Combination
TTX-030 plus pembrolizumab
干预措施: TTX-030 (Drug)
Arm 2, Anti-PD-1 Combination
TTX-030 plus pembrolizumab
干预措施: Pembrolizumab (Drug)
Arm 4, Chemotherapy Combination
TTX-030 plus gemcitabine plus nab-paclitaxel
干预措施: TTX-030 (Drug)
Arm 4, Chemotherapy Combination
TTX-030 plus gemcitabine plus nab-paclitaxel
干预措施: Gemcitabine (Drug)
Arm 4, Chemotherapy Combination
TTX-030 plus gemcitabine plus nab-paclitaxel
干预措施: nab paclitaxel (Drug)
结局指标
主要结局
Objective Response Rate (ORR) - Arm 1 and Arm 2 Expansion Cohorts
时间窗: Through study completion, an average of 1 year
Anti-tumor activity in subjects treated with TTX-030 as single agent or in combination with specified regimens
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
时间窗: 1 cycle (each cycle is 21-28 days)
A DLT was defined as any clinically significant AE that occurred during Treatment Cycle 1 that the Investigator or Sponsor considered as possibly or likely related to TTX-030 as a single agent, or the combination of TTX-030 and other agent(s), and met the following criteria: NCI CTCAE Version 5.0 Grade 5 event, Grade 4 hematological or Grade≥3 non-hematological toxicities, or Grade≥3 irAEs. Laboratory abnormalities that were asymptomatic and deemed not clinically significant were not regarded as DLTs. During Dose Escalation, each dosing cohort was completed through the DLT observation window before escalation was allowed within its arm. In each Safety Lead-in cohort, all participants were closely monitored for the occurrence of DLTs.
次要结局
- Objective Response Rate (ORR) (Except for Arm 1 and 2 Expansion Cohorts, Where ORR Was a Primary Endpoint)(Through study completion, an average of 1 year)
- Maximum Plasma Concentration (Cmax)(Cycles 1-3 (each cycle is 21-28 days))
