NCT04891653Unknown1 期
A Open-label, Multi-center Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics and Efficacy of BR790 Monotherapy in Subjects With Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 48
- 主要终点
- Dose limiting toxicity (DLT)
研究概览
简要总结
The purpose of the study was to evaluate the safety and tolerability of BR790 tablets as an oral monotherapy in subjects with advanced solid tumors, and to determine dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and/or recommended phase II clinical trial dose (RP2D) .The study is divided into two phases: dose escalation phase and dose expansion phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign informed consent voluntarily.
- •Age ≥18 and ≤75 years old.
- •Subjects with advanced solid tumors diagnosed by histology or cytology，whose desease progressed after standard treatment or have no standard treatment.
- •Had at least one measurable lesion.
- •Expected survival period ≥ 3 months.
排除标准
- •Any previous treatment with SHP-2 inhibitor.
- •Symptomatic brain metastases.
- •Subjects with thoracic/ascites fluid that need drainage or intervention.
- •Subjects with not enough organ functional reserve at baseline, which met at least one of the following criteria： ANC<1.5×10^9/L PLT<100×10^9/L Hb<90g/L TBIL>1.5×ULN ALT, AST>2.5×ULN (without liver metastases) or ALT, AST>5×ULN (with liver metastases), Cr >1.5×ULN.
- •With uncontrolled severe disease.
研究组 & 干预措施
5-65mg QD
Experimental
干预措施: BR790 (Drug)
结局指标
主要结局
Dose limiting toxicity (DLT)
时间窗: up to 32 day
maximum tolerated dose (MTD)
时间窗: up to 32 day
recommended phase II clinical study dose (RP2D)
时间窗: up to 32 day
次要结局
- Cmax(up to 32 day)
- t1/2(up to 32 day)
- pERK(up to 32 day)
- AUC(up to 32 day)
- ORR(through study completion, an average of 3 years)
- AE(through study completion, an average of 3 years)
研究者
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