A Phase 1/1b Dose-Escalation Trial Evaluating CPI-818, an Oral Interleukin-2-Inducible T-Cell Kinase Inhibitor, in Subjects With Relapsed/Refractory T-Cell Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 151
- 试验地点
- 22
- 主要终点
- Incidence, nature, and severity of adverse events following treatment with CPI 818 to establish the safety and tolerability with increasing dose
研究概览
简要总结
This is a Phase 1/1b, open-label, first in human study of CPI-818, an oral interleukin-2-inducible tyrosine kinase (ITK) inhibitor for the treatment of relapsed/refractory (R/R) T-cell lymphoma.. This trial will study the safety, tolerability, and anti-tumor activity of CPI-818 as a single drug.
详细描述
This is a Phase 1/1b, open-label, first in human study of CPI-818, an oral interleukin-2-inducible tyrosine kinase (ITK) inhibitor for the treatment of relapsed/refractory (R/R) T-cell lymphoma.. This trial will study the safety, tolerability, and anti-tumor activity of CPI-818 as a single drug. This trial is composed of dose escalation and dose expansion cohorts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Adult subjects age ≥18 years
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •Histologically confirmed evidence of T-cell lymphoma
- •Measurable disease.
- •Adequate organ function.
- •At least 2 standard therapies for advanced or recurrent disease or had a disease for which there is no more than one established therapy.
排除标准
- •Treatment with systemic immunosuppressive medication.
- •History of allogeneic hematopoietic stem cell transplantation.
- •History of primary immunodeficiency, solid organ transplantation.
- •History of opportunistic infection within 180 days of starting study drug.
- •Females who are pregnant, lactating, or intend to become pregnant
- •History of invasive prior malignancy that required systemic therapy within last 3 years.
- •Concomitant use of strong inhibitors or inducers of CYP3A.
研究组 & 干预措施
CPI-818 Dose Escalation
Participants will receive CPI-818 capsule, orally, twice per day at an assigned dose, till disease progression, complete response or remission (CR) for >2 months or if dose determined to be unsafe.
干预措施: CPI-818 (Drug)
CPI-818 Dose Expansion phase
Participants with different T-cell lymphoma sub-types will receive CPI-818 capsules at the specific dose selected from the Dose escalation phase of the study.
CPI-818 capsules at the selected dose will be taken orally, twice per day until disease progression or CR for > 2 months.
干预措施: CPI-818 (Drug)
结局指标
主要结局
Incidence, nature, and severity of adverse events following treatment with CPI 818 to establish the safety and tolerability with increasing dose
时间窗: First dose until 30 days after treatment stop
Incidence and nature of dose limiting toxicities (DLTs) of CPI 818 to establish either the maximum tolerated dose (MTD) or the maximum administered dose (MAD) of CPI 818
时间窗: Up to approximately 21 days after first dose
次要结局
- Area under the curve (AUC) of CPI-818 in blood samples to evaluate the pharmacokinetic profile of CPI 818(Day 1, 2, 8, 15 of Cycle 1, Day 1 and 2 of Cycle 3, and Day 1 for all even number Cycles. Each Cycle is 21 days.)
- Evaluate total percentage of tumor gene expression in post-treatment blood and tumor samples to evaluate pharmacodynamic changes with treatment.(Day 1, 2, 8, 15 of Cycle 1, Day 1 and 2 of Cycle 3, and Day 1 for all even number Cycles. Each Cycle is 21 days.)
- Evaluate overall percentage of malignant cells in post-treatment blood and tumor samples to evaluate pharmacodynamic changes with treatment.(Day 1, 2, 8, 15 of Cycle 1, Day 1 and 2 of Cycle 3, and Day 1 for all even number Cycles. Each Cycle is 21 days.)
- Maximum serum concentration (Cmax) of CPI-818 in blood samples to evaluate the pharmacokinetic profile of CPI 818(Day 1, 2, 8, 15 of Cycle 1, Day 1 and 2 of Cycle 3, and Day 1 for all even number Cycles. Each Cycle is 21 days.)
- Objective response rate per Laguno Classification for CTCL and Consensus Statement for Response for CTCL to assess the anti-tumor activity of CPI 818 in subjects with R/R T cell lymphoma(From start of treatment through end of study treatment, up to approximately 24 months)