A Phase 1/1B First-in-Human Study of the SHP2 Inhibitor BBP-398 (Formerly Known as IACS-15509) in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 72
- 试验地点
- 10
- 主要终点
- Determination of Maximum Tolerated Dose (MTD) and establish the RP2D of BBP-398.
研究概览
简要总结
A first-in-human study to evaluate the safety, tolerability and maximum tolerated dose (MTD) and establish the recommended phase 2 dose (RP2D) of BBP-398, a SHP2 inhibitor, in patients with advanced solid tumors.
详细描述
The first-in-human (FIH) study of BBP-398 will be an open-label, sequential-cohort, non-randomized, Phase 1/1B study utilizing BOIN dose escalation followed by an expansion phase in patients with MAPK pathway- or RTK-driven advanced solid tumors. The primary objective is to determine safety and tolerability of BBP-398, the MTD and RP2D. The secondary objectives are to assess the pharmacokinetic (PK) and pharmacodynamic (PD) profile, preliminary anti-tumor activity, objective response rate (ORR, complete response + partial response rate) and the duration of response (DoR) of BBP-398. The exploratory objective is to assess predictive biomarkers of response.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dose Escalation
Oral capsules taken in escalating levels to determine MTD/RP2D. Each treatment cycle will be 28 days in duration with BBP-398 administered, once daily (QD).
干预措施: BBP-398 (Formerly known as IACS-15509) (Drug)
Dose Expansion
Oral capsules administered at MTD/RP2D defined dose. Each treatment cycle will be 28 days in duration with BBP-398 administered, once daily (QD)
- Cohort A: Advanced or metastatic KRAS mutant solid tumor
- Cohort B: Advanced solid tumor with NF1 loss-of-function (LOF) or metastatic BRAF class II/III mutant solid tumor
干预措施: BBP-398 (Formerly known as IACS-15509) (Drug)
结局指标
主要结局
Determination of Maximum Tolerated Dose (MTD) and establish the RP2D of BBP-398.
时间窗: Completion of 1 Cycle ( 28 days)
The MTD will be based on DLT.
次要结局
- Time to reach Cmax (Tmax) of BBP-398(Approximately 6 weeks)
- Determination of anti-tumor activity of BBP-398(After 1 dose of BBP-398)
- Terminal half-life (t1/2) of BBP-398(Approximately 6 weeks)
- Maximum observed plasma concentration (Cmax) of BBP-398(Approximately 6 weeks)
- Area under the plasma concentration-time curve (AUC) of BBP-398(Approximately 6 weeks)