NCT05598151进行中（未招募）1 期
A Phase I, Open-Label, Multicenter, Dose Escalation and Expansion Study of HM97662 as a Single Agent in Patients With Advanced or Metastatic Solid Tumors
Hanmi Pharmaceutical Company Limited10 个研究点 分布在 2 个国家目标入组 170 人开始时间: 2023年1月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 170
- 试验地点
- 10
- 主要终点
- Incidence and nature of DLTs
研究概览
简要总结
This is a Phase1 study to assess the safety, PK, PD and efficacy of HM97662, EZH1/2 dual inhibitor, in solid tumors. The study is comprised of Dose-Escalation Part followed by randomized Dose-Ranging Part and Dose-Expansion Part. Dose-Escalation Part is planned with a 3+3 Dose-Escalation design and is to establish the MTD or RD for randomized Dose-Ranging Part. Dose-Ranging Part is designed mainly to further evaluate safety and preliminary efficacy of HM97662 monotherapy in subjects with specific genomic alterations to more precisely determine the potential RP2D that are to be tested in a Dose-Expansion Part. Dose-Expansion Part is designed to assess the potential efficacy of HM97662 monotherapy when administered at the RP2D to subjects in indication-specific expansion cohorts.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically and/or cytologically confirmed advanced or metastatic solid tumor who have failed/are intolerant to standard therapy.
- •Patients for dose-escalation part must have evaluable or measurable disease at baseline and the patients for randomized dose-ranging and dose-expansion part must have at least one measurable lesion at baseline by CT or MRI per Response Evaluation Criteria in Solid Tumor (RECIST v1.1).
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Life expectancy ≥ 3 months before starting HM
- •Adequate renal function.
- •Adequate hematologic function.
- •Adequate liver function.
- •Males or females aged ≥ 18 years (or country's legal age of majority if the legal age was > 18 years) at the time of informed consent.
- •For Dose-Ranging Part, documentation of an alteration in at least one of the genes of the SWI/SNF complex in tumor tissue (archival or newly obtained).
排除标准
- •Prior exposure to valemetostat or other EZH1/2 dual inhibitor.
- •Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms.
- •Patients currently taking medications that are known strong CYP3A inhibitors and strong or moderate CYP3A inducers.
- •Any prior treatment-related (i.e. chemotherapy, immunotherapy, radiotherapy) clinically significant toxicities that have not resolved to Grade ≤ 1 per CTCAE version 5.0 or prior treatment-related toxicities that are clinically unstable and clinically significant at time of enrollment.
- •Major surgery within 4 weeks before the first dose of study drug treatment in Cycle
- •Females who are pregnant or breastfeeding.
- •Patients who have undergone an organ transplant.
研究组 & 干预措施
HM97662
Experimental
Tablet, oral administration, once daily (QD), continuous dosing
干预措施: HM97662 (Drug)
结局指标
主要结局
Incidence and nature of DLTs
时间窗: Days 1-28 of Cycle 1 (DLT assessment period) in Dose-Escalation Part
Incidence, nature, and severity of adverse events and laboratory abnormalities graded per NCI CTCAE v5.0
时间窗: until Safety Follow-up, 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first
次要结局
- Area under the concentration-time curve (AUC)(until Cycle 4 Day1 (each cycle is 28 days))
- Trough plasma concentration (Ctrough)(until Cycle 4 Day1 (each cycle is 28 days))
- Apparent volume of distribution (Vd/F)(until Cycle 4 Day1 (each cycle is 28 days))
- The maximum plasma concentration (Cmax)(until Cycle 4 Day1 (each cycle is 28 days))
- Apparent clearance (CL/F)(until Cycle 4 Day1 (each cycle is 28 days))
- Objective response(Day 1 of Cycles 3, 5, 7 (each cycle is 28 days) and further (every 8 weeks) until disease progression (assessed up to 5 years))
- Time to reach Cmax (Tmax)(until Cycle 4 Day1 (each cycle is 28 days))
- Terminal Half-life (T1/2)(until Cycle 4 Day1 (each cycle is 28 days))
研究者
研究点 (10)
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