A Phase 1/2a Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of FORE8394 in Patients With Advanced Unresectable Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 113
- 试验地点
- 13
- 主要终点
- Compare Cmax of FORE8394 with FORE8394
研究概览
简要总结
The objective of this study is to determine the safety, pharmacokinetics, maximum tolerated dose/recommended Phase 2 dose, and efficacy of FORE8394.
详细描述
Dose Escalation (Part 1): To evaluate safety, pharmacokinetics, pharmacodynamics of FORE8394 in adult and pediatric patients with advanced BRAF- mutated tumors, and to identify the recommended Phase 2 Dose.
Dose Extension (Part 2): To access objective tumor response to FORE8394 treatment in adult and in adolescent patients with advanced BRAF- mutated tumors, to access RECIST, and to access pharmacokinetics, pharmacodynamics, and safety.
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
- 10 Years 至 —（Child, 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
FORE8394
Group A: Phase 1-Dose Escalation: Adult patients.
Group B: Phase 1-Dose Escalation: Pediatric patients.
Phase 2a-Dose Extension: Adult patients with advanced unresectable solid tumors will be enrolled among two cohorts.
- Cohort 1: Activating BRAF V600 mutations (glioma patients only)
- Cohort 2: Activating BRAF non-V600 mutations
Phase 2a-RP2D Confirmation: Adult patients.
Phase 2a-RP2D Redefinition and Extension:
- Cohort 3: Activating BRAF V600 or activating non-V600 mutation
- Cohort 4: Activating BRAF non-V600 mutations
Phase 2a-RP2D Redefinition:
- Cohort 6A: Advanced activating BRAF-mutated solid tumors
- Cohort 7A: Advanced activating BRAF-mutated solid tumors
- Cohort 8A: Advanced activating BRAF-mutated solid tumors
干预措施: FORE8394 (Drug)
结局指标
主要结局
Compare Cmax of FORE8394 with FORE8394
时间窗: First dose of FORE8394 up to 30 days after end of treatment
Time to peak concentration (Tmax) of FORE8394
时间窗: First dose of FORE8394 up to 30 days after end of treatment
To identify the recommended Phase 2 dose (RP2D) of FORE8394 in Group A (adult patients) for further evaluation in Dose Extension.
时间窗: 2 years
To determine the overall response rate of FORE8394 treatment at the applicable RP2D in a) Group A, Cohort 1, and b) Group A, Cohort 2.
时间窗: 5 years
Area under the curve (AUC) of FORE8394
时间窗: First dose of FORE8394 up to 30 days after end of treatment
Half life (T1/2) of FORE8394
时间窗: First dose of FORE8394 up to 30 days after end of treatment
Number of participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v4.0.
时间窗: First dose of FORE8394 up to 30 days after end of treatment
Compare AUC of FORE8394 with FORE8394
时间窗: First dose of FORE8394 up to 30 days after end of treatment
Compare Tmax of FORE8394 with FORE8394
时间窗: First dose of FORE8394 up to 30 days after end of treatment
Compare T1/2 of FORE8394 with FORE8394
时间窗: First dose of FORE8394 up to 30 days after end of treatment
Maximum concentration (Cmax) of FORE8394
时间窗: First dose of FORE8394 up to 30 days after end of treatment
次要结局
- To evaluate the duration of response (defined as time of initial response to progressive disease or death) at the applicable RP2D in Dose Extension.(5 years)
- To evaluate the progression free survival (defined as time of first dose to progressive disease or death) at the applicable RP2D in Dose Extension.(5 years)
- Clinical benefit rate (defined as stable disease, partial response and complete response) after 24 weeks on study(5 years)