A Phase 1, Open-Label, Multicenter, Dose Escalation Study of SGR-1505 as Monotherapy in Subjects With Mature B-Cell Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 98
- 试验地点
- 50
- 主要终点
- Nature, severity, and number of incidences of adverse events (AEs), serious AEs (SAEs), and AEs leading to treatment discontinuation.
研究概览
简要总结
The purpose of this study is to evaluate safety and tolerability and to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and/or recommended dose (RD) of SGR-1505.
详细描述
This is a study of SGR-1505, an oral inhibitor of MALT1, in subjects with relapsed/refractory (R/R) B-cell lymphomas to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), maximum tolerated dose (MTD) or maximum administered dose (MAD) and/or recommended dose (RD) of SGR-1505. Exploratory cohorts will evaluate additional PK, PD, preliminary anti-tumor activity, and safety to establish the SGR-1505 RD. A planned amendment will evaluate SGR-1505 in combination with other anti-cancer agents, such as BTK and BCL-2 inhibitors, in patients with specific B-cell malignancies.
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
- •Subject must have a history of histologically or cytologically confirmed mature B-cell malignancy.
- •Subject must have measurable or detectable disease according to the applicable disease-specific classification system and meet criteria for initiation of treatment.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Life expectancy ≥ 12 weeks.
排除标准
- •The subject is in need of immediate cytoreductive therapy (unless the patient has no remaining treatment choice with potential benefit).
- •Subject has previous invasive malignancy in the last 2 years.
- •Subject has a known allergy to SGR-1505 or excipients of SGR-
- •Subject has symptomatic or active CNS involvement of disease.
- •Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that would place the participant at increased risk to the use of an investigational drug.
研究组 & 干预措施
Dose Escalation
Up to 9 dose levels in total will be evaluated across two dosing schedules. Eligible patients will be assigned to a dose level cohort according to an accelerated titration design that will transition to a traditional 3+3 dose escalation.
干预措施: SGR-1505 (Drug)
结局指标
主要结局
Nature, severity, and number of incidences of adverse events (AEs), serious AEs (SAEs), and AEs leading to treatment discontinuation.
时间窗: Throughout the study, up to 2 years.
Nature and number of incidences of dose limiting toxicity (DLT).
时间窗: The first 21 days.
A DLT is an AE that requires treatment interruption.
次要结局
- SGR-1505 Time to Maximal Plasma Concentration (tmax)(Through study completion, up to 2 years.)
- SGR-1505 Area Under the Concentration Versus Time Curve (AUC)(Through study completion, up to 2 years.)
- Objective Response Rate (ORR)(Throughout the study, up to 2 years.)
- SGR-1505 Maximal Plasma Concentration (Cmax)(Through study completion, up to 2 years.)
- Duration of Response (DOR)(Throughout the study, up to 2 years.)
- Disease Control Rate(Throughout the study, up to 2 years.)