jRCT2031240650招募中不适用
AKTive-001: A Phase 1/1b Multiple Cohort Trial of ALTA2618 in Patients with Advanced Solid Tumors with AKT1 E17K Mutation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 主要终点
- Number of participants that experience treatment-emergent adverse events (TEAEs)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Histologically confirmed diagnosis of a solid tumor malignancy harboring AKT1 E17K mutation identified through molecular testing (NGS- or PCR-based).
- •Unresectable or metastatic disease.
- •Progressed on, intolerant to, or declined prior standard-of-care therapy (including targeted therapy, if applicable) appropriate to tumor type and stage.
- •Evaluable or measurable disease per RECIST v1.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Adequate organ function.
排除标准
- •Prior treatment with PI3K and/or mTOR inhibitors.
- •Patients known to have KRAS, NRAS, HRAS, or BRAF genomic alterations in their tumor.
- •Known condition that prohibits ability to swallow or absorb an oral medication.
结局指标
主要结局
Number of participants that experience treatment-emergent adverse events (TEAEs)
Number of participants that experience treatment-emergent adverse events (TEAEs)
Number of participants with Dose Limiting Toxicities (DLTs)
Number of participants with Dose Limiting Toxicities (DLTs)
次要结局
- Overall Response Rate (ORR)
- Duration of Response (DOR)
- Progression-Free Survival (PFS)
- Overall Survival (OS)
研究者
相似试验
尚未招募
不适用
A Study to Learn About a Study. Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe DiseasejRCT2031240698Pfizer Japan Inc.2,330
尚未招募
不适用
A Study to Understand How the Study Medicine Dazukibart Works in People With Idiopathic Inflammatory MyopathiesjRCT2031250053Pfizer Japan Inc.211
尚未招募
不适用
A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual MigraineMenstrual MigrainejRCT2031250041Pfizer Japan Inc.723
招募中
不适用
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe AsthmaAsthmajRCT2031250163Pfizer Japan Inc.252
招募中
不适用
A Study to Learn About the Study Medicine Called PF-07321332 (Nirmatrelvir)/Ritonavir in Patients Under 18 Years of Age With COVID-19 That Are Not Hospitalized But Are at Risk for Severe Disease (EPIC-Peds)jRCT2031250096Pfizer Japan Inc.160