A First-in-human, Open-label, Dose Escalation and Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Activity of 3HP-2827 in Patients With Unresectable or Metastatic Solid Tumors With FGFR2 Alterations
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Dose Escalation Stage- incidence of adverse events (AEs)
研究概览
简要总结
The study is being conducted to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of 3HP-2827 in the treatment of unresectable or metastatic solid tumors with FGFR2 alterations. Patients will be enrolled in two stages: dose escalation stage (Stage I) and expansion stage (Stage II).
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
- •The patient is willing and able to provide written informed consent and has the ability to comply with the study protocol
- •Men or women, age ≥ 18 years at the time of signing informed consent.
- •Histologically or cytologically confirmed surgically unresectable, locally advanced, metastatic solid tumor.
- •ECOG score is 0 or
- •An expected survival of ≥ 12 weeks.
- •Evaluable or measurable disease per RECIST v1.
- •Adequate organ function, as measured by laboratory values.
排除标准
- •Active brain metastases.
- •Have other malignancies within the past 3 years.
- •The toxicity from previous anti-tumor treatment has not recovered to ≤ grade
- •Clinically significant corneal or retinal disease/keratopathy.
- •Clinically significant cardiovascular disorders.
- •Failure to swallow, chronic diarrhea, or presence of other factors affecting drug absorption.
- •Known to be allergic to any study drug or any of its excipients.
- •Any other diseases or clinical laboratory, etc that may affect the interpretation of the results, or renders the patients at high risk from treatment complications.
研究组 & 干预措施
Stage I - dose escalation
Dose escalation of 3HP-2827 in patients with advanced solid tumors.
干预措施: 3HP-2827 (Drug)
Stage II - expansion
Expansion evaluating the recommended dose and schedule of 3HP-2827 identified from Stage I.
干预措施: 3HP-2827 (Drug)
结局指标
主要结局
Dose Escalation Stage- incidence of adverse events (AEs)
时间窗: From baseline up until 28 days after the final dose
Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted ECG Parameters
时间窗: From baseline up until 28 days after the final dose
Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted Vital Signs
时间窗: From baseline up until 28 days after the final dose
Dose Escalation Stage- incidence of dose-limiting toxicities (DLTs)
时间窗: Days 1-28 of Cycle 1 (a cycle is 28 days)
Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test Results
时间窗: From baseline up until 28 days after the final dose
Dose Escalation Stage -determine the maximum tolerated dose (MTD) and/or the recommended dose (RD) for expansion stage or recommended Phase II dose (RP2D) of 3HP-2827
时间窗: Initiation of study drug until study discontinuation, (up to approximately 24 months)
Expansion stage -Objective response rate（ORR）
时间窗: Initiation of study drug until disease progression (up to approximately 36 months)
次要结局
- Plasma Concentration of 3HP-2827 and/or its major metabolites(Initiation of study drug until study discontinuation（up to 45 months）)
- Expansion Stage- incidence of adverse events (AEs)(From baseline up until 28 days after the final dose)
- Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted Vital Signs(From baseline up until 28 days after the final dose)
- Duration of Response (DOR) as assessed by RECIST v1.1(Up to 45 months)
- Progression-free survival (PFS) as assessed by RECIST v1.1(Up to 45 months)
- Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted ECG Parameters(From baseline up until 28 days after the final dose)
- Dose escalation stage - Objective Response Rate (ORR)(Up to 45 months)
- Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test Results(From baseline up until 28 days after the final dose)
- Overall survival(Up to 48 months)