NCT05843305尚未招募1 期
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BPI-452080 in Subjects With Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 87
- 试验地点
- 5
- 主要终点
- adverse events (AEs)
研究概览
简要总结
This open-label Phase 1 study will evaluate the efficacy and safety of BPI-452080 in patients with Solid Tumors
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
- •Histologically or cytologically confirmed locally advanced or metastatic solid tumor patients, who had disease progression after standard therapy, intolerable to standard therapy, refuse to standard therapy or for whom no standard therapy exists
- •Dose expansion phase:
- •Arm1：has locally advanced or metastatic ccRCC and has progressed during treatment with at least one prior therapeutic regimen Arm2：Von Hippel-Lindau Disease-Associated Clear Cell Renal Cell Carcinoma Arm3：Other solid tumors
- •Adequate organ function
- •Evaluable lesion required for dose escalation phase and at least 1 measurable lesion required for dose expansion phase
排除标准
- •Has received prior treatment with another HIF-2α inhibitor
- •Inadequate wash-out of prior therapies described per protocol, which may include anti-tumor therapies, tumor adjuvant drugs, organ or stem cell transplantation, moderate or strong CYP3A inhibitor or inducer, etc
- •Patients with major surgery within 4 weeks, severe or unstable systemic disease, unstable/symptomatic CNS metastasis, other malignant tumors, ILD, clinical significant cardiac disease, bleeding or embolic disease, active infectious disease, or other medical or psychiatric condition that might interfere with participation in the trial or interfere with the interpretation of trial results, in the opinion of the investigator or medical monitor
- •Pregnancy or lactation
研究组 & 干预措施
Dose Escalation
Experimental
Oral tablets taken in escalating levels to determine MTD/RP2D. Each treatment cycle will be 21 days in duration with BPI-452080 administered once daily.
干预措施: BPI-452080 (Drug)
Dose Expansion
Experimental
Oral tablets administered at MTD/RP2D defined dose. Each treatment cycle will be 21 days in duration with BPI-452080 administered once daily.
Cohort 1: Locally Advanced or Metastatic ccRCC Cohort 2: VHL disease associated RCC Cohort 3: Other Advanced Solid Tumors
干预措施: BPI-452080 (Drug)
结局指标
主要结局
adverse events (AEs)
时间窗: Through the Phase I, approximately 24 months
Safety and tolerability will be assessed by monitoring frequency, duration and severity of adverse events
次要结局
- Cmax(Through the Phase I, approximately 24 months)
- Tmax(Through the Phase I, approximately 24 months)
- t1/2(Through the Phase I, approximately 24 months)
- the objective response rate（ORR）(Through the Phase I, approximately 24 months)
- Progression free survival (PFS)(Through the Phase I, approximately 24 months)
研究者
研究点 (5)
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