A Phase I/II, Open Label, Multi-center, Non-randomized Dose Escalation and Dose Expansion Study of AMXI-5001 in Patients With Advanced Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 122
- 试验地点
- 8
- 主要终点
- Determine the Maximum Tolerated Dose (MTD)
研究概览
简要总结
ATLAS-101 is a Phase I/II clinical trial of AMXI-5001 in adult participants with advanced malignancies who have previously failed other therapies. The study has two phases. The purpose of Phase I (Dose Escalation) is to confirm the appropriate treatment dose and Phase II (Dose Expansion) is to characterize the safety and efficacy of AMXI-5001.
详细描述
AMXI-5001 is an orally available dual PARP (poly adenosine diphosphate [ADP] ribose polymerase) and microtubule polymerization inhibitor. ATLAS-101 is a Phase I/II, open label, multi-center, non-randomized Dose Escalation and Dose Expansion study in participants with advanced malignancies. Study enrollment is approximately 122 participants. All participants receive oral AMXI-5001, twice daily, as monotherapy. Following Phase I (Dose Escalation) to identify the Maximum Tolerated Dose and the Recommended Dose for use in Phase II, additional participants will be enrolled into the Dose Expansion Phase to further characterize the safety, pharmacology, and clinical efficacy of AMXI-5001.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •(Key Factors):
- •Has pathologically confirmed advanced or metastatic malignancy characterized by one or more of the following:
- •Patient is intolerant of existing therapy(ies) known to provide clinical benefit for their condition
- •Malignancy is refractory to existing therapy(ies) known to potentially provide clinical benefit
- •Malignancy has progressed after standard therapy
- •Has evaluable or measurable tumor(s) in dose escalation by standard radiological and/or laboratory assessments as applicable to their malignancy.
- •Eastern Co-operative Oncology Group (ECOG) PS 0-1
- •Participant must be 18 years of age or older
- •Able to understand and sign consent
排除标准
- •(Key Factors):
- •Receiving cancer treatment at the time of enrollment
- •Any clinically significant disease or condition affecting a major organ system
- •Significant cardiovascular disease or electrocardiogram (ECG) abnormalities
- •Use of a strong inhibitor or inducer of CYP3A4 within 7 days prior to start of study therapy and throughout the study (e.g., some antibiotics, antifungals, anticonvulsants, grapefruit)
- •Has had a previous (within 2 years) or has a current malignancy other than the target cancer
结局指标
主要结局
Determine the Maximum Tolerated Dose (MTD)
时间窗: Approximately 12 months
The highest dose is defined at which no more than 1 of 6 evaluable participants has had a Dose Limiting Toxicity (DLT) according to NCI CTCAE V5.0 criteria and determination by Investigator and Data and Safety Monitoring Committee.
Determine the Recommended Phase 2 Dose (RP2D) for AMXI-5001 as monotherapy
时间窗: Approximately 12 months
The RP2D is based upon the review of all available data including safety, pharmacokinetic, preliminary anti-tumor activity, and MTD.
Characterize safety profile of AMXI-5001
时间窗: Approximately 24 months
The safety profile of AMXI-5001 is defined by the incidence of treatment emergent adverse events, laboratory abnormalities, and ECG measurements.
次要结局
- Measure concentration of AMXI-5001 in plasma samples(Approximately 24 months)
- Determine change in anti-tumor activity following administration of AMXI-5001(Approximately 24 months)