NCT05211570招募中1 期
A Phase 1/2 Study to Assess the Safety, Pharmacokinetics, and Efficacy of Daily Intravenous AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
AB Science10 个研究点 分布在 4 个国家目标入组 78 人开始时间: 2022年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 78
- 试验地点
- 10
- 主要终点
- Rate of dose limiting toxicity (DLT)
研究概览
简要总结
The primary objective is to define the safety and tolerability of AB8939 in patients with AML by determining the dose-limiting toxicities, the maximum tolerated dose, and the recommended dose for dose expansion study.
详细描述
This is a Phase 1/2, open-label, multi-center, non-randomized, 2-part study in patients with refractory and relapsed AML and refractory myelodysplastic syndrome.
Study AB18001 has a multi-stage design. The first part is a dose escalation study that aims to determine the safety, tolerability and pharmacokinetic profiles of consecutive daily intravenous administration of AB8939 in patients with refractory or relapsed AML or patients with refractory myelodysplastic syndrome, and to determine the recommended dose for the second-stage dose expansion study. This dose expansion study aims to determine the schedule for a Phase 2 trial in patients with relapsed/refractory AML and to also provide an early efficacy assessment of AB8939.
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
- •Patients with documented diagnosis of acute myeloid leukemia (AML) based on the last version of the World Health Organization classification and eligible to second or third line of treatment.
- •Patients with documented diagnosis of refractory melyodisplastic syndrome in second or third line of treatment, and with high risk at prognosis based on the IPSS-R scoring system.
- •ECOG performance status ≤ 1
- •Patients are able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures
- •Patients are able and willing to comply with study procedures as per protocol, including bone marrow biopsies
排除标准
- •Patients eligible to a standard of care
- •Patients eligible to hematopoietic stem cell transplantation (HSCT) at the time of inclusion
- •Patients diagnosed with acute promyelocytic leukemia (M3)
- •Patients with clinically active CNS leukemia
- •Patients with HSCT within 100 days prior to the first administration of AB8939
- •Women who are lactating/breastfeeding or who plan to breastfeed while on study
- •Women with a positive pregnancy test
- •Other protocol-defined inclusion/exclusion criteria may apply
- •EXPANSION COHORT STUDY
- •Key Inclusion Criteria:
- •Patients with documented diagnosis of acute myeloid leukemia (AML) based on the last version of the World Health Organization classification and eligible to second or third line of treatment.
- •ECOG performance status ≤ 2
- •Patients are able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures
- •Patients are able and willing to comply with study procedures as per protocol, including bone marrow biopsies
- •Key Exclusion Criteria:
- •Patients eligible to a standard of care
- •Patients eligible to hematopoietic stem cell transplantation (HSCT) at the time of inclusion
- •Patients diagnosed with acute promyelocytic leukemia (M3)
- •Patients with clinically active CNS leukemia
- •Patients with HSCT within 100 days prior to the first administration of AB8939
- •Women who are lactating/breastfeeding or who plan to breastfeed while on study
- •Women with a positive pregnancy test
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
AB8939
Experimental
AB8939 administered as a single agent
干预措施: AB8939 (Drug)
AB8939 plus Venetoclax
Experimental
AB8939 administered in combination with venetoclax
干预措施: AB8939 (Drug)
AB8939 plus Venetoclax
Experimental
AB8939 administered in combination with venetoclax
干预措施: Venetoclax (Drug)
结局指标
主要结局
Rate of dose limiting toxicity (DLT)
时间窗: Up to 56 days
Identification of the Maximal Tolerated Dose for different dosing schedules
次要结局
- Objective Response Rate(Up to 56 days)
研究者
研究点 (10)
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相关资讯
AB Science's AB8939 Plus Venetoclax Achieves 67% ORR in Phase 1 Trial for High-Risk Relapsed/Refractory AML- AB Science completed Step 3 of its Phase 1 trial evaluating AB8939 combined with venetoclax in six heavily pre-treated patients with relapsed/refractory AML and adverse genetics.
- The combination achieved a 67% overall response rate and 100% disease control rate after a single 14-day cycle, with no dose-limiting toxicities observed.
- Responses were seen in patients with TP53 mutations, MECOM rearrangements, complex karyotypes, and monosomy 5/7 — genetic profiles typically associated with poor prognosis.
- The company will now advance to Step 4 evaluating the triple combination of AB8939, venetoclax, and azacitidine, and plans an expansion study in approximately 15 patients.2 months agoAB Science's AB8939 Shows Promise Against Refractory Acute Myeloid Leukemia with Novel Dual-Target Mechanism- AB Science published preclinical data on bioRxiv demonstrating AB8939's novel dual mechanism targeting both proliferating tumor cells through microtubule disruption and resistant stem cells via ALDH inhibition.
- The compound showed nanomolar potency against hematopoietic cancers and overcame major drug resistance mechanisms including P-glycoprotein efflux and β3-tubulin expression in preclinical studies.
- In patient-derived xenograft models of high-risk AML with MECOM rearrangements, AB8939 monotherapy was effective and combination with azacitidine achieved near-complete disease clearance.
- AB8939 is currently being evaluated in a Phase I/II clinical trial (NCT05211570) with regulatory approval recently received for the third stage combining the drug with venetoclax.9 months agoAB Science Provides Update on Masitinib and AB8939 Clinical Programs- AB Science is re-examining the marketing authorization application for masitinib in amyotrophic lateral sclerosis (ALS) with the EMA and Health Canada.
- Phase 1 trial of AB8939 shows promising activity against MECOM-rearranged acute myeloid leukemia (AML), with potential for accelerated FDA approval.
- Masitinib demonstrates potential as an alternative to BTK inhibitors in progressive forms of multiple sclerosis, based on ECTRIMS 2024 data.last year