A Phase 1/2 Study of a Selective FGFR2/3 Inhibitor, CGT4859, in Patients With Cholangiocarcinoma and Other Advanced Solid Tumors Harboring FGFR2 and/or FGFR3 Genetic Alterations
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 110
- 试验地点
- 27
- 主要终点
- Phase 1: Determine the maximum tolerated dose (MTD) and RP2D of CGT4859 - AEs
研究概览
简要总结
This is an open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetic (what the body does to the drug), pharmacodynamic (what the drug does to the body), and antitumor activity of CGT4859 in adult participants with intrahepatic cholangiocarcinoma (iCCA) or other advanced solid tumors with FGFR2 and/or FGFR3 genetic alternations.
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 confirmed locally advanced, metastatic, and/or unresectable iCCA or other solid tumor with documented FGFR2/3 alteration in blood and/or tumor.
- •Previously treated with, not appropriate for, or declined standard-of-care first-line treatment.
- •Have measurable disease per RECIST v1.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits.
- •Resolution of toxicities from prior therapy to ≤Grade 1 (or baseline), including resolution of clinically significant laboratory abnormalities, before the first dose of study drug. Exceptions are alopecia, hypothyroidism, or type 1 diabetes mellitus controlled with medical intervention, and paronychia controlled with local intervention.
排除标准
- •Received chemotherapy or anticancer therapies or radiotherapy within certain timeframes before first dose of study drug.
- •Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug.
- •Clinically significant corneal or retinal disorders or current evidence of retinal detachment.
- •Received more than 2 prior FGFRi therapies
- •Active, symptomatic, or untreated brain metastases unless the participant is clinically stable and off corticosteroids for ≥2 months.
研究组 & 干预措施
Phase 2: Signal Seeking
Oral dose of CGT4859 at the RP2D as determined in Phase 1
干预措施: CGT4859 (Drug)
Phase 1: Dose Escalation
Multiple doses of CGT4859 for oral administration
干预措施: CGT4859 (Drug)
结局指标
主要结局
Phase 1: Determine the maximum tolerated dose (MTD) and RP2D of CGT4859 - AEs
时间窗: Approximately 12 months
Incidence, severity, and seriousness or treatment-emergent adverse events (AEs) leading to dose modification
Phase 1: Determine the maximum tolerated dose (MTD) and RP2D of CGT4859 - Laboratory results
时间窗: Approximately 12 months
Clinically significant changes or abnormalities observed from baseline in laboratory results in chemistry, hematology, and coagulation parameters
Phase 1: Determine the maximum tolerated dose (MTD) and RP2D of CGT4859 - ECG results
时间窗: Approximately 12 months
Clinically significant changes or abnormalities observed from baseline in electrocardiogram (ECG) parameters
Phase 2: Evaluate antitumor activity of CGT4859 - Objective Response Rate (ORR)
时间窗: Approximately 8 months
次要结局
- Phase 1: Pharmacokinetics(Approximately 28 days)
- Phase 2: Pharmacokinetics at RP2D(Approximately 28 days)
- Phase 2: Characterize the safety of CGT4859 - Labs, ECG(Approximately 9 months)
- Phase 1: Evaluate antitumor activity of CGT4859 - Objective Response Rate (ORR)(Approximately 8 months)
- Phase 1 and Phase 2: Evaluate antitumor activity of CGT4859 - Disease Control Rate (DCR)(Approximately 8 months)
- Phase 2: Characterize the safety of CGT4859 - AEs(Approximately 9 months)