NOVA-BCL6-1, A First-in-Human, Multicenter Phase 1a/1b Study to Investigate Safety, Tolerability, Pharmacokinetics, and Efficacy of LY4584180 in Adult Participants With Previously Treated Hematologic Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 460
- 试验地点
- 46
- 主要终点
- Number of Dose-Limiting Toxicities (DLTs) and DLT-Equivalent Toxicities
研究概览
简要总结
The main purpose of this study is to evaluate safety and efficacy, and measure how much LY4584180 gets into the bloodstream and how long it takes the body to eliminate it in patients with previously treated blood cancers. For each participant, the study could last about 9 months or possibly longer including screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Has been treated for the following blood cancers and has received at least 2 prior lines of systemic therapy or not eligible for available therapy:
- •Diffuse large B-cell lymphoma - not otherwise specified
- •High-grade B-cell lymphoma
- •Diffuse large B-cell lymphoma - transformed from indolent lymphomas
- •Follicular large B-cell lymphoma
- •Follicular lymphoma
- •Other non-Hodgkin lymphoma
- •Has measurable disease
- •Has discontinued all previous treatments for cancer and has recovered from the immediate effects of therapy
排除标准
- •Has an active second cancer
- •Has known central nervous system (CNS) involvement by systemic lymphoma. Patients with previous treatment for CNS involvement who are neurologically stable and without evidence of active CNS disease may be eligible and enrolled if a compelling clinical rationale is provided by the Investigator and with documented Sponsor approval.
- •Has known Cytomegalovirus infection. Participants with negative status are eligible
- •Has known hepatitis B or C infection or uncontrolled HIV
- •Has known significant heart disease
研究组 & 干预措施
Phase 1a-Monotherapy Dose Escalation (Cohort A1)
LY4584180 monotherapy administered orally
干预措施: LY4584180 (Drug)
Phase 1b-Dose Expansion-Combination (Cohort B4)
LY4584180 administered orally in combination with rituximab administered through IV infusion
干预措施: Rituximab (Drug)
Phase 1a-Monotherapy Dose Optimization (Cohort A2)
LY4584180 monotherapy administered orally
干预措施: LY4584180 (Drug)
Phase 1b-Dose Expansion-Monotherapy (Cohort B1-B3)
LY4584180 monotherapy administered orally
干预措施: LY4584180 (Drug)
Phase 1b-Dose Expansion-Combination (Cohort B4)
LY4584180 administered orally in combination with rituximab administered through IV infusion
干预措施: LY4584180 (Drug)
结局指标
主要结局
Number of Dose-Limiting Toxicities (DLTs) and DLT-Equivalent Toxicities
时间窗: Baseline up to Day 28
Number of Dose-Limiting Toxicities (DLTs) and DLT-Equivalent Toxicities
Number of Participants with One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline up to 3 Years
Number of Participants with One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug Administration
To Evaluate the Preliminary Antitumor Activity of LY4584180: Objective Response Rate (ORR)
时间窗: Baseline up to 3 Years
To Evaluate the Preliminary Antitumor Activity of LY4584180: Objective Response Rate (ORR)
次要结局
- Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of LY4584180(Baseline to Day 8)
- PK: Area Under the Concentration (AUC) Versus Time Curve of LY4584180(Baseline to Day 8)