A Multicenter, Open-label Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Dosimetry and Efficacy of BPR-6023021 in Subjects With Advanced Solid Tumors With Bone Metastases.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
研究概览
简要总结
A multicenter, open-label Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, dosimetry and efficacy of BPR-6023021 in subjects with advanced solid tumors with bone metastases
详细描述
This study is a multicenter, open-label Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, dosimetry and efficacy of BPR-6023021 in subjects with advanced solid tumors with bone metastases. The study is divided into two parts: Phase I and Phase II. The Phase I study is the dose escalation phase. The primary objective is to assess the safety and tolerability of a single administration of BPR-6023021 and to determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) based on the occurrence of Dose-Limiting Toxicities (DLTs) associated with BPR-6023021 (if the MTD cannot be determined).The Phase II study is the dose expansion phase. The primary objective is to explore the efficacy of BPR-6023021 at a selected dose level.
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
Phase 1:Dose escalation
5 dose levels of BPR-6023021 are tentatively planned for Phase 1
干预措施: BPR-6023021 for injection (Drug)
Phase 2: RP2D Cohort
Participants will receive BPR-6023021 for injection at the Recommended Phase 2 Dose (RP2D) determined from the Phase 1 dose escalation study.The dose of BPR-6023021 for injection in Phase 2 is selected based on the Phase 1 monotherapy dose escalation study.
干预措施: BPR-6023021 for injection (Drug)
结局指标
主要结局
Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
时间窗: Up to 1 year
次要结局
- Dosimetry，including Maximum plasma concentration (Cmax) of BPR-6023021(Through study completion, an average of 2 year)
- Time to Radiographic Bone Progresion (TTRBP)(Through study completion, an average of 2 year)
- Radiographic progression-free survival (rPFS)(Through study completion, an average of 2 year)
- Symptomatic skeletal event-free survival (SSE-FS)(Through study completion, an average of 2 year)