2023-509067-24-00撤回2 期
A Phase 2 Evaluation of the Safety and Efficacy of AL8326 in ≥2nd Line Small Cell Lung Cancer (SCLC) Treatment
Advenchen Pharmaceuticals LLC9 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2024年6月19日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 30
- 试验地点
- 9
- 主要终点
- OBD and ORR for all dosing groups and OBD group plus expansion cohort
研究概览
简要总结
To determine the optimal biological dose (OBD) based on efficacy and safety of each dosing group. ORR for all dosing groups and OBD group plus expansion cohort for = or >2nd line treatment of AL8326 for SCLC patients.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Phase 2 expansion cohort
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Male or female, 18 years of age or older.
- •ECOG performance status of 0 or
- •Histologically or cytologically confirmed SCLC.
- •Have at least 1 lesion that meets the criteria for being measurable, as defined by RECIST 1.
- •Have a life expectancy of at least 3 months.
排除标准
- •Serious, non-healing wound, ulcer or bone fracture Major surgical procedure within 28 days or minor surgical procedure performed within 7 days prior to treatment Active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels Clinically significant cardiovascular disease including uncontrolled hypertension; myocardial infarction or unstable angina within 6 months prior to enrollment; New York Heart Association (NYHA) Grade II or greater congestive heart failure serious cardiac arrhythmia requiring medication; and Grade II or greater peripheral vascular disease Hemoptysis within 3 months prior to enrollment Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9 and CYP2C19 within 14 days prior to enrollment and during the study unless there is an emergent or life-threatening medical condition that required it.
结局指标
主要结局
OBD and ORR for all dosing groups and OBD group plus expansion cohort
OBD and ORR for all dosing groups and OBD group plus expansion cohort
次要结局
- DOR for OBD group plus expansion cohort; PFS; Pharmacokinetic endpoints such as Cmax, AUC and other typic PK parameters; and PK/PD/Efficacy/Safety relationship. Possible biomarker identification
研究者
Victoria Rico, M.S. Clinical Project Manager
Scientific
Advenchen Pharmaceuticals LLC
研究点 (9)
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