2023-506581-31-00招募中1 期
A Phase 1/2, First-in-Human Study of theMenin-KMT2A (MLL1)Inhibitor Bleximenib in Participants with Acute Leukemia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 21
- 主要终点
- Phase 1: Part 1 (Dose Escalation): Incidence and severity of adverse events, including dose-limiting toxicity
研究概览
简要总结
Phase 1: Part 1 (Dose Escalation): Determine the (RP2Ds of bleximenib Phase 1: Part 2 (Dose Expansion): Determine the safety and tolerability at the RP2D(s) Phase 2: To evaluate the efficacy of bleximenib at the RP2D
入排标准
- 年龄范围
- 0 years 至 65+ years（65+ Years, 0-17 Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Phase 1 and Phase 2 adult cohorts: ≥ 18 years of age and Phase 1 adolescent cohort 12 to <18 years of age
- •Phase 1: R/R acute leukemia and has exhausted, or is ineligible for, available therapeutic options.
- •Phase 1: Acute leukemia harboring KMT2A, NPM1 or nucleoporin alterations. Phase 2: AML harboring KMT2A-r or NPM1 mutations only.
- •Pretreatment clinical laboratory values meeting the criteria
- •ECOG performance status grade of 0, 1 or
- •A female of childbearing potential must have a negative highly sensitive serum β-human chorionic gonadotropin at screening and within 48 hours prior to the first dose of study treatment
排除标准
- •Diagnosed with acute promyelocytic leukemia, Down syndrome associated leukemia or juvenile myelomonocytic leukemia.
- •Active CNS involvement
- •Prior solid organ transplantation
- •Cardiovascular disease that increases the risk for torsades de pointes or that was diagnosed within 6 months prior to the first dose of study treatment.
- •QTc ≥450 milliseconds for males or ≥470 milliseconds for females
- •Any toxicity from previous anticancer therapy that has not resolved to baseline or to Grade 1 or less
- •Pulmonary compromise that requires the need for supplemental oxygen use to maintain adequate oxygenation
- •Reported temperature >100.5ºF/38ºC within 48 hours prior to the first dose of study treatment
- •Known allergies, hypersensitivity, or intolerance to bleximenib or its excipients.
结局指标
主要结局
Phase 1: Part 1 (Dose Escalation): Incidence and severity of adverse events, including dose-limiting toxicity
Phase 1: Part 1 (Dose Escalation): Incidence and severity of adverse events, including dose-limiting toxicity
Phase 1: Part 2 (Dose Expansion): Incidence and severity of adverse events
Phase 1: Part 2 (Dose Expansion): Incidence and severity of adverse events
Phase 2: Rate of CR/CRh assessed by the IRC.
Phase 2: Rate of CR/CRh assessed by the IRC.
次要结局
未报告次要终点
研究者
CTIS Point of Contact
Scientific
Janssen - Cilag International
研究点 (21)
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