A Phase Ia/Ib, Open-Label, First-in-human, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BC3195 in Patients With Locally Advanced or Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Incidence of dose limiting toxicities (DLTs) .
研究概览
简要总结
This is a phase I study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Efficacy of BC3195 in Patients with Locally Advanced or Metastatic Solid Tumors.
详细描述
This is a phase I study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Efficacy of BC3195 in Patients with Locally Advanced or Metastatic Solid Tumors.
The patients in whom standard treatment has failed (either due to disease progression or intolerance), who meet the criteria will receive BC3195 via intravenous (IV) in 21-day treatment cycles.
A Safety Monitoring Committee (SMC) will be established to decide the dose levels to be administered and dose regimen during dose escalation based on a thorough review of all the safety, PK (if applicable), and other relevant data from the previous dose cohort, and to determine the MTD and the putative RP2D for dose expansion.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients voluntarily participate in the study and should provide a written informed consent.
- •Male or female patients ≥ 18 years of age.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Subjects with locally advanced or metastatic solid tumors failed to prior SOCs and no appropriate SOC to treat the current disease per investigator's judgement.
- •Life expectancy ≥ 3 months.
- •Subjects with adequate organ function.
- •Men or women of childbearing potential (which refer to men or women who have not been surgically sterilized and pre-menopausal women) must use a highly effective method of contraception during the study and continue to take contraception measures for 6 months after the last dose of the study drug.
排除标准
- •Pregnant or lactating women.
- •Prior systemic anticancer treatment within 5 half-lives or 4 weeks before the first dose (whichever is shorter).
- •Active viral infection requiring systemic therapy during the screening period.
- •Hypertension that cannot be well-controlled with medical treatment.
- •Cardiovascular disease of clinical significance.
- •Subjects with any active infection that requires anti-infective therapy judged by the investigators.
- •Subjects are not suitable for participating the study judged by the investigators.
- •Subjects with poor compliance, who are unwilling to or unable to follow study procedures.
结局指标
主要结局
Incidence of dose limiting toxicities (DLTs) .
时间窗: Dose limiting toxicities (DLT) will be assessed At the end of Cycle 1 (each cycle is 21 days).
次要结局
未报告次要终点