NCT05780034招募中1 期
A Phase I Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-Malignancy Activity of AC676 in Patients With Relapsed/Refractory B-cell Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 9
- 主要终点
- Incidence of dose limiting toxicities (DLTs) from AC676 monotherapy
研究概览
简要总结
This clinical trial is evaluating a drug called AC676 in participants with Relapsed/Refractory B-cell Malignancies. The main goals of the study are to:
- Identify the recommended dose of AC676 that can be given safely to participants
- Evaluate the safety profile of AC676
- Evaluate the pharmacokinetics of AC676
- Evaluate the effectiveness of AC676
详细描述
AC676-001 is a Phase I, first-in-human, open-label, multi-center dose-escalation study of AC676 given as a single agent. AC676 is an investigational medicinal product that is an orally bioavailable BTK degrader for the treatment of B-cell malignancies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 male and female patients, at least 18 years-of-age at the time of signature of the informed consent form (ICF).
- •Patients with histologically confirmed relapsed/refractory Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), Mantle Cell Lymphoma (MCL), Follicular Lymphoma (FL), non-GCB Diffuse Large B-cell Lymphoma (DLBCL), Marginal Zone Lymphoma (MZL), or Waldenström Macroglobulinemia (WM).
- •Must have received at least 2 prior systemic therapies or have no other therapies to provide significant clinical benefit in the opinion of the Investigator or who are not amenable (intolerability, patient choice) to standard therapies.
排除标准
- •Patients who meet any of the following criteria will be excluded from study entry:
- •Treatment with any of the following:
- •Small molecule anti-cancer drugs within 5 half-lives or 2 days (whichever is longer, not to exceed 14 days).
- •Systemic chemotherapy within 14 days.
- •Radiation therapy within 14 days
- •Biologics (Antibodies) treatment within 28 days,
- •Radioimmunoconjugates or toxin conjugates within 12 weeks.
- •Prior Chimeric antigen receptor (CAR) T cell therapy (and prior use of immunoglobulin replacement therapy to treat associated adverse events) within 3 months. For patients with DLBCL, no prior CAR- T therapy is allowed.
- •Autologous or allogenic stem cell transplant within 100 days and must not have ongoing graft-versus-host disease (GVHD) and no ongoing therapy to treat GVHD.
- •History of central nervous system lymphoma/leukemia in remission for less than 2 years.
- •Medical history of active bleeding within 2 months prior to study entry, or susceptible to bleeding by the judgement of investigator.
研究组 & 干预措施
AC676 Dose Escalation
Experimental
Participants will receive an assigned dose of AC676 in a 28-days cycle.
干预措施: AC676 (Drug)
结局指标
主要结局
Incidence of dose limiting toxicities (DLTs) from AC676 monotherapy
时间窗: From cycle 1 day 1 to Cycle 1 day 28. Cycles are 28 days.
Incidence of treatment-emergent adverse events (TEAEs) and clinically significant Grade 3 or higher laboratory abnormalities using CTCAE v5.0 criteria.
时间窗: Approximately 18 months
Maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D)
时间窗: Approximately 18 months
次要结局
- Pharmacokinetic Analysis: time to maximum plasma concentration (tmax)(Up to approximately 20 weeks)
- Objective Response Rate (ORR) in patients receiving AC676(Approximately 18 months)
- Time to Response (TTR) in patients receiving AC676(Approximately 18 months)
- Progression Free Survival rate (PFS) in patients receiving AC676(Approximately 18 months)
- Pharmacokinetic Analysis: maximum plasma concentration (Cmax)(Up to approximately 20 weeks)
- Disease Control Rate (DCR) in patients receiving AC676(Approximately 18 months)
- Duration of Response (DOR) in patients receiving AC676(Approximately 18 months)
- Pharmacokinetic Analysis: area under the plasma concentration-time curve over the dosing interval (AUC(0-inf))(Up to approximately 20 weeks)
- Pharmacokinetic Analysis: terminal elimination half-life (t1/2)(Up to approximately 20 weeks)
- Pharmacokinetic Analysis: area under the plasma concentration-time curve from over the dosing interval (AUC(0-tau))(Up to approximately 20 weeks)
研究者
研究点 (9)
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