A PhaseⅠStudy to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of FDA022-BB05 in Subjects With Advanced Solid Malignant Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity (DLT)
研究概览
简要总结
This is a Phase 1, open-label and two-part study to evaluate the safety, tolerability, pharmacokinetics and efficacy of FDA022-BB05 in participants with advanced/metastatic solid malignant tumors.
详细描述
This is a first-in-human (FIH), Phase 1, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of FDA022-BB05 in patients with advanced/metastatic solid tumors. FDA022-BB05 is administered via intravenous infusion using an accelerated titration method followed by a conventional 3 + 3 study design to identify dose-limiting toxicities（DLT）and the maximum tolerated dose (MTD) through Day1 and Day 21 (cycle 1) with 1 dose. In addition, the recommended Phase II dose of FDA022-BB05 will be determined.
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 75 Years（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 Ia Dose escalation
Phase Ia: Participants with locally advanced or metastatic tumor will be administered FDA022-BB05 intravenously once at escalated doses in each cycle (of 21 days) during Phase Ia part of the study until disease progression or intolerable toxicity.
干预措施: FDA022 Monoclonal antibody-drug conjugate for injection Phase Ia (Drug)
Phase Ib Dose expansion
Phase Ib: is a dose expansion to examine the safety and efficacy of FDA022-BB05 and it is consist of multiple cohorts: in subjects with HER2 overexpressing breast cancer (Cohort A); HER2 overexpressing gastric or gastroesophageal junction adenocarcinoma (Cohort B).
干预措施: FDA022 Monoclonal antibody-drug conjugate for injection Phase Ib (Drug)
结局指标
主要结局
Dose-limiting toxicity (DLT)
时间窗: Cycle 1 (21Days)
DLT will be assessed according to NCICTCAE v5.0.
Maximum tolerated dose (MTD）
时间窗: Cycle 1 (21 Days)
MTD will be defined as the maximum dose level at which no more than 1 of 3 patients experience a DLT within cycle1 (21 days) of DLT observing period.
RP2D
时间窗: Cycle1 (21 Days)
the recommended phase II dose
Incidence of treatment-related adverse events (AEs) and serious adverse events (SAEs)
时间窗: Up to 3 years
The AEs and SAEs will be assessed according to the National Cancer Institute (NCI) CTCAE v5.0.
次要结局
- Pharmacokinetic (PK) characteristics, CL/F(From cycle1 to Cycle10 (each cycle is 21 days. ))
- Pharmacokinetic (PK) characteristics，AUC(From cycle1 to Cycle10 (each cycle is 21 days. ))
- ADA(Up to 18 months)
- DoR(Up to 18 months)
- OS(Up to 3 years)
- Pharmacokinetic (PK) characteristics, Cmax(From cycle1 to Cycle10 (each cycle is 21 days. ))
- Pharmacokinetic (PK) characteristics, Tmax(From cycle1 to Cycle10 (each cycle is 21 days. ))
- Pharmacokinetic (PK) characteristics, t1/2(From cycle1 to Cycle10 (each cycle is 21 days. ))
- ORR(Up to 18 months)
- PFS(Up to 18 months)