A Phase 1/2, Open-label, Dose Escalation and Expansion Study to Evaluate the Safety and Tolerability of LBS-007 in Patients With Relapsed or Resistant Acute Leukaemias
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 14
- 主要终点
- Number, severity and duration of adverse events (AEs) and treatment-related AEs according to Common Terminology Criteria for Adverse Events (CTCAE) v5.
研究概览
简要总结
The most common types of acute leukaemia are acute lymphoblastic leukaemia (ALL) and acute myeloid leukaemia (AML). AML is a heterogenous clonal disorder of haemopoietic progenitor cells and the most common and severe malignant leukemia in adults and is responsible for the highest mortality from leukemia. ALL is a neoplasm characterized by the growth of malignant lymphoblasts of the B or T lineage, leading to an inhibition of proliferation of the normal blood cell lineages.
The primary objectives of this study are investigating the safety, tolerability, and the MTD of LBS-007. The secondary objectives are to assess the efficacy and to determine the pharmacokinetics (PK) of LBS-007. The exploratory objective is to study and correlate the changes in surrogate biomarkers in response to treatment.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects greater than 18 years old, inclusive.
- •Pathologically confirmed diagnoses of Relapsed or resistant AML or ALL.
- •Patients who are ineligible for standard therapies that are anticipated to result in durable remission or cure, or who have no known therapy options of documented benefit.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
排除标准
- •Concomitant chemotherapy, radiation therapy, or immunotherapy.
- •Receiving any other investigational agents concurrently or within 30 days prior to screening.
- •Patient has acute promyelocytic leukaemia or leukemia with active CNS involvement.
- •History of another active malignancy with 2 years prior to study entry, basal cell skin cancer and previous carcinoma in treated curatively.
- •Patient with mental deficits and/or psychiatric history that precludes them from giving informed consent or from following protocol.
研究组 & 干预措施
Dose Finding and Expansion Phase
Phase 1: Dose finding phase to evaluate LBS-007 as a monotherapy and combination with Venetoclax and Azacitidine Phase 2: Dose expansion phase to evaluate LBS-007 as a monotherapy and combination therapy at the optimal dose identified by phase 1 (dose finding)
干预措施: LBS-007 (Drug)
结局指标
主要结局
Number, severity and duration of adverse events (AEs) and treatment-related AEs according to Common Terminology Criteria for Adverse Events (CTCAE) v5.
时间窗: From baseline through 28 days after end of last treatment cycle (up to 12 months)
Recommended Phase 2 Dose (RP2D) of LBS-007 in the subject population.
时间窗: From baseline through 28 days after end of last treatment cycle (up to 12 months)
次要结局
- Maximum Plasma Concentration (Cmax) of LBS-007 in plasma.(Immediately before treatment initiation on Day 1, 3, and 5, or before treatment completion (Day 8), - Then 0.5 (±5 minutes), 1, 2, 4, 6, 10, and 24 (±15 minutes) hours after treatment initiation (Day 1) or completion (Day 8) of first treatment cycle.)
- Time to Maximum Plasma Concentration (Tmax) of LBS-007 in plasma.(Immediately before treatment initiation on Day 1, 3, and 5, or before treatment completion (Day 8), - Then 0.5 (±5 minutes), 1, 2, 4, 6, 10, and 24 (±15 minutes) hours after treatment initiation (Day 1) or completion (Day 8) of first treatment cycle.)
- Area under the drug concentration-time curve (AUC) of LBS-007 in plasma.(Immediately before treatment initiation on Day 1, 3, and 5, or before treatment completion (Day 8), - Then 0.5 (±5 minutes), 1, 2, 4, 6, 10, and 24 (±15 minutes) hours after treatment initiation (Day 1) or completion (Day 8) of first treatment cycle.)
- Efficacy of LBS-007 assessed by bone marrow and peripheral blood.(From baseline through 28 days after end of last treatment cycle (up to 12 months))