A Phase 1/2 Study of TAS3351 in Patients With Advanced Non-Small Cell Lung Cancer and EGFR Mutations
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 17
- 主要终点
- Dose Expansion: To explore the efficacy of TAS3351
研究概览
简要总结
This is a first-in-human, open label, Phase 1/2 study to investigate the safety and efficacy of TAS3351 in patients with advanced or metastatic non-small cell lung cancer (NSCLC) harboring an acquired C797S epidermal growth factor receptor (EGFR) mutation.
详细描述
This study will be conducted in 3 parts (i.e. dose escalation, dose expansion, and a phase 2 portion). The dose escalation part will investigate the safety and determine the recommended phase 2 dose and the recommended dosing regimen of TAS3351 administered orally. The dose expansion part will explore the efficacy of TAS3351 in NSCLC patients with C797S EGFR mutations. The phase 2 part will assess the efficacy of TAS3351 in NSCLC patients with C797S EGFR mutations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Locally advanced, non-resectable or metastatic NSCLC
- •Have adequate organ function
- •Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
- •Has tumor tissue available to allow for analysis of EGFRmt status
- •Dose Escalation:
- •Has any EGFRmt status
- •Dose Escalation back-fill part, Dose Expansion and Phase II:
- •Has any sensitizing EGFRmt and a confirmed C797S EGFRmt
- •Has measurable disease per RECIST v1.1
排除标准
- •Participating in medical research not compatible with this study
- •Symptomatic and unstable CNS metastases
- •Have not recovered from prior cancer treatment
- •Have a significant cardiac condition
- •Are a pregnant or breastfeeding female
- •A serious illness or medical condition
- •Unable to swallow or digest pills
研究组 & 干预措施
TAS3351 Part A (Dose Escalation)
Dose escalation will assess the safety and determine the recommended phase 2 dose and regimen of TAS3351 administered orally.
干预措施: TAS3351 oral administration (Drug)
TAS3351 Part B (Dose Expansion)
TAS3351 in NSCLC patients with C797S EGFRmt. TAS3351 will be administered at the recommended phase 2 dose determined in Part A.
干预措施: TAS3351 oral administration (Drug)
TAS3351 Part C (Phase 2)
To assess efficacy of TAS3351 in NSCLC patients with C797S EGFRmt. TAS3351 will be administered at the recommended phase 2 dose.
干预措施: TAS3351 oral administration (Drug)
结局指标
主要结局
Dose Expansion: To explore the efficacy of TAS3351
时间窗: estimated 9 months
Objective Response Rate (ORR)
Dose Escalation: To investigate the safety and determine the recommended Phase 2 dose and dosing schedule of TAS3351
时间窗: baseline through cycle 1(each cycle is 21 days)
Incidence of dose limiting toxicities (DLTs)
Phase 2: To assess the efficacy of TAS3351
时间窗: estimated 3 years
Objective Response Rate (ORR)
次要结局
- Phase 2:To evaluate patient reported outcomes (PROs)(estimated 3 years)
- Dose Escalation: To characterize the pharmacokinetics (PK) of TAS3351(ECycle 1 Day 1 through cycle 1 Day 15 (21-Day cycle))
- Phase 2: To further assess the efficacy of TAS3351(estimated 3 years)
- Dose Escalation:To evaluate the antitumor activity of TAS3351(estimated 20 months)
- Dose Expansion: To further explore the anti-tumor efficacy of TAS3351(estimated 9 months)
- Dose Escalation: To evaluate the antitumor activity of TAS3351(estimated 20 months)
- Dose Expansion: To confirm the safety and tolerability of TAS3351 at the recommended phase 2 dose and dosing schedule(estimated 9 months)
- Phase 2: To evaluate the safety and tolerability of TAS3351(estimated 3 years)