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
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 110
- 试验地点
- 46
- 主要终点
- Adverse Events
研究概览
简要总结
The purpose of this study is to characterize the safety and tolerability of ALTA2618 in adults with AKT1 E17K-mutant advanced solid tumors.
详细描述
This is an open-label, multicenter, Phase 1/1b study of ALTA2618, a mutant-selective and orally bioavailable AKT1 E17K inhibitor, in adults with AKT1 E17K-mutant solid tumors. This study will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary clinical activity of ALTA2618, and aims to find the best dose. The study consists of two parts: Part 1 - Dose Escalation and Part 1b - Dose Expansion.
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
- 18 Years 至 65+ years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of a solid tumor malignancy harboring AKT1 E17K mutation identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic test.
- •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 v1.1
- •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
- •Other inclusion/exclusion criteria may apply.
研究组 & 干预措施
ALTA2618
ALTA2618 will be administered continuously at a protocol-defined dose based on cohort assignment
干预措施: ALTA2618 (Drug)
结局指标
主要结局
Adverse Events
时间窗: Up to 39 months
Number of participants that experience treatment-emergent adverse events (TEAEs).
Dose Limiting Toxicities
时间窗: 21 days
Number of participants with Dose Limiting Toxicities (DLTs).
次要结局
- Maximum Observed Plasma Concentration (Cmax)(Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 8: Predose and up to 24 hours postdose)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 8: Predose and up to 24 hours postdose)
- Area Under Plasma Concentration Time Curve During the Dosing Interval (AUCt)(Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 8: Predose and up to 24 hours postdose)
- Terminal Half-Life (t1/2)(Cycle 1 (each cycle is 21 days) Lead-in phase: Predose and up to 72 hours postdose)
- Overall Response Rate (ORR)(Up to 39 months)
- Duration of Response (DOR)(Up to 39 months)
- Progression-Free Survival (PFS)(Up to 39 months)
- Overall Survival (OS)(Up to 39 months)
研究者
Alterome Clinical Trial Contact Center
Scientific
Alterome Therapeutics Inc.