A Phase 1/2a, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-30355 in Adult Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 144
- 试验地点
- 16
- 主要终点
- Dose limiting toxicity (DLT)
研究概览
简要总结
This study is to evaluate the efficacy and safety of JAB-30355 in adult participants with advanced solid tumors harboring TP53 Y220C mutation.
详细描述
This study consists of two parts: Dose Escalation Phase (Phase 1) and Dose Expansion Phase (Phase 2a). The primary objective of dose escalation is to evaluate the safety and tolerability, and to determine the MTD of JAB-30355 monotherapy administered in participants with advanced solid tumors harboring TP53 Y220C mutation. Dose expansion will further explore JAB-30355's clinical benefit and tolerability in selected dose levels.
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
- •Written informed consent.
- •Participant must be ≥18 years of age at the time of signing the Informed Consent Form (ICF).
- •ECOG performance status score of 0 or
- •Has been treated with at least one line of systemic therapy for that tumor type and stage.
- •Have documentation of confirmed TP53 Y220C mutation.
- •At least 1 measurable lesion per RECIST v1.
- •Adequate hematological, renal and hepatic function and appropriate coagulation condition.
- •Able to swallow and retain orally administered medication.
排除标准
- •Active brain or spinal metastases or primary CNS tumor.
- •Active infection requiring systemic treatment within 7 days.
- •Active HBV or HCV.
- •Any severe and/or uncontrolled medical conditions.
- •LVEF ≤50% assessed by ECHO or MUGA.
- •QTcF>470 msec.
研究组 & 干预措施
Dose expansion phase
Dose Expansion Phase will explore JAB-30355's clinical benefit and optimal tolerability in selected dose level.
干预措施: JAB-30355 (Drug)
Dose escalation phase
Multiple dose levels of JAB-30355 will be explored to determine the maximum tolerated dose (MTD)
干预措施: JAB-30355 (Drug)
结局指标
主要结局
Dose limiting toxicity (DLT)
时间窗: Approximately one year
Number and proportion of participants who experience at least one dose limiting toxicity (DLT)
Number of participants with adverse events
时间窗: Approximately three years
All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms et al.
次要结局
- Terminal half-life (t1/2)(Approximately three years)
- Duration of response (DOR)(Approximately three years)
- Time to reach the observed maximum (peak) concentration (Tmax)(Approximately three years)
- Peak Plasma Concentration (Cmax)(Approximately three years)
- Objective response rate (ORR)(Approximately three years)