StrataPATH™ (Precision Indications for Approved Therapies): A Study Evaluating the Clinical Activity and Safety of Approved Drugs Within Biomarker-Guided Patients With Solid Tumors
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 4
- 主要终点
- Overall response rate (ORR) defined as the percentage of participants with a best overall response of CR or PR based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, as assessed by the investigator
研究概览
简要总结
StrataPATH™ is a non-randomized, open-label trial designed to explore efficacy and safety of multiple FDA-approved and commercially available cancer therapies in new, biomarker-guided patient populations.
详细描述
StrataPATH is a non-randomized, open-label trial designed to explore efficacy and safety of multiple FDA-approved and commercially available cancer therapies in new, biomarker-guided patient populations. Aiming to increase clinical benefit for patients, this study will leverage technology advancements, scientific literature, and Strata's real-world evidence to define novel, highly responsive pan-tumor molecular indications for FDA-approved therapies in both the advanced and micro-metastatic settings. Strata will rapidly identify participants who have efficacy signals for possible expansion into adaptive or randomized studies. Enrollment in each drug/biomarker cohort is competitive. Cohorts may be added, changed, or discontinued over the course of the study
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Lorbrena® (lorlatinib)
干预措施: lorlatinib (Drug)
Braftovi® (encorafenib) + Mektovi® (binimetinib)
干预措施: encorafenib + binimetinib (Drug)
Talzenna® (talazoparib)
干预措施: talazoparib (Drug)
Trodelvy® (sacituzumab govitecan-hziy)
干预措施: sacituzumab govitecan (Drug)
Inlyta® (axitinib)
干预措施: axitinib (Drug)
Enhertu® (fam-trastuzumab deruxtecan-nxki)
干预措施: Fam-Trastuzumab Deruxtecan-Nxki (Drug)
Padcev® (enfortumab vedotin)
干预措施: enfortumab vedotin (Drug)
结局指标
主要结局
Overall response rate (ORR) defined as the percentage of participants with a best overall response of CR or PR based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, as assessed by the investigator
时间窗: Assessed throughout end of study, up to 5 years
RECIST criteria will be used to assess the clinical activity of cancer treatments in participants with pre-specified biomarker profiles.
次要结局
- Overall Survival (OS)(Assessed throughout end of study, up to 5 years)
- Incidence of serious adverse events (SAEs)(Assessed throughout end of study, up to 5 years)
- Time to Treatment Discontinuation (TTD) defined as length of time from the date the participant initiates the systemic treatment to the date the participant discontinues treatment as compared to prior TTD from prior cancer treatment(Assessed throughout end of study, up to 5 years)
- ctDNA response: The proportion of participants with a <50% ratio of mean variant allele frequency (VAF) will be defined as ctDNA responders(6 months)
- Duration of Response (DoR) defined as the time from first documentation of disease response (CR or PR) until first documentation of progressive disease(Assessed throughout end of study, up to 5 years)
- TTnT (Time to Next Treatment) defined as the length of time from the date the participant initiates study treatment to the date the participant initiates their next systemic treatment or death.(Assessed throughout end of study, up to 5 years)
- ctDNA Response Rate(Assessed throughout end of study, up to 5 years)