Study of GS-2426 in Participants With Advanced Solid Tumors
2026年7月31日 更新者：Gilead Sciences
A Phase 1, Multicenter, Open-Label Clinical Study to Evaluate the Safety and Tolerability of GS-2426 in Participants With Advanced MTAP-Deleted Solid Tumors
The goal of this clinical study is to learn more about the study drug GS-2426, and how safe and tolerable it is in participants with advanced methylthioadenosine phosphorylase (MTAP)-deleted solid tumors.
The primary objective of this study is to evaluate the safety and tolerability of GS-2426 in participants with MTAP-deleted advanced solid tumors and to determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) and the recommended phase II dose (RP2D).
研究概览
研究类型
介入性
注册 (估计的)
174
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Gilead Clinical Study Information Center
- 电话号码：1-833-445-3230 (GILEAD-0)
- 邮箱：GileadClinicalTrials@gilead.com
学习地点
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Michigan
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Grand Rapids、Michigan、美国、49546
- 招聘中
- START MidWest
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New Jersey
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East Brunswick、New Jersey、美国、08816
- 招聘中
- START Astera, LLC
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New York
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New York、New York、美国、10065
- 招聘中
- Memorial Sloan Kettering Cancer Center
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Texas
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San Antonio、Texas、美国、78229
- 招聘中
- START San Antonio, LLC
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Key Inclusion Criteria:
- Participants 18 years of age or older (≥ 19 years old for participants in South Korea).
- Histologically or cytologically confirmed advanced malignant solid tumors, who have progressed on, are intolerant to or are ineligible for standard therapy, or have no standard treatment options.
- Participant tumors are methylthioadenosine phosphorylase (MTAP)-deficient.
- Adequate organ function
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- All participants must provide a pretreatment tumor tissue sample.
Key Exclusion Criteria:
- Participants with plans to breastfeed during the study period or within 7 days following the last dose of study intervention.
- Have not recovered (ie, returned to Grade 1 or baseline) from clinically significant adverse events (AEs) due to a previously administered agent or a previous intervention as assessed by the investigator.
- Active second malignancy. Individuals with a history of malignancy who have been completely treated with no evidence of active cancer for 5 years prior to enrollment, or individuals with surgically cured tumors with low risk of recurrence may be enrolled.
- Requirement for ongoing therapy with any prohibited medications .
- Prior therapy with a protein arginine methyltransferase 5 (PRMT5) inhibitor or methionine adenosine transferase 2a (MAT2A) inhibitor.
- Have serious infection requiring antibiotics within 14 days prior to the first dose.
- Uncontrolled concurrent diseases
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：顺序分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Phase 1a: Monotherapy Dose Escalation
Participants will receive escalating doses of GS-2426 monotherapy, until disease progression, or until the participant meets other study drug discontinuation criteria as specified in protocol, or up to a maximum of 105 week, whichever occurs first.
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Administered Orally
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实验性的：Phase 1b: Monotherapy Dose Expansion
Participants will be enrolled in different indication-specific cohorts.
Participants will receive GS-2426 monotherapy at the recommended dose until disease progression, or until the participant meets other study drug discontinuation criteria as specified in protocol, or up to a maximum of 105 weeks, whichever occurs first.
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Administered Orally
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAE)
大体时间：First dose up to 30 days post last dose (up to 105 weeks)
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First dose up to 30 days post last dose (up to 105 weeks)
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Percentage of Participants Experiencing Clinical Laboratory Abnormalities
大体时间：First dose up to 30 days post last dose (up to 105 weeks)
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First dose up to 30 days post last dose (up to 105 weeks)
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Maximum Tolerated Dose (MTD)/Maximum Administered Dose (MAD)
大体时间：First dose up to 21 days post first dose
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First dose up to 21 days post first dose
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Recommended Phase 2 Dose (RP2D)
大体时间：Predose to end of study (up to 105 weeks)
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Predose to end of study (up to 105 weeks)
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Percentage of Participants Experiencing Any Dose-limiting Toxicities (DLTs)
大体时间：First dose up to 21 days post first dose
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First dose up to 21 days post first dose
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Plasma Concentration of GS-2426
大体时间：Predose and postdose up to end of treatment (up to 105 weeks)
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Predose and postdose up to end of treatment (up to 105 weeks)
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Pharmacokinetic (PK) Parameter: AUC0-24h of GS-2426
大体时间：Predose and postdose up to end of treatment (up to 105 weeks)
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AUC0-24h is defined as the area under concentration versus time from 0 to 24 hours.
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Predose and postdose up to end of treatment (up to 105 weeks)
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PK Parameters: Cmax of GS-2426
大体时间：Predose and postdose up to end of treatment (up to 105 weeks)
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Cmax is defined as the maximum observed plasma drug concentration.
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Predose and postdose up to end of treatment (up to 105 weeks)
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PK Parameters: Tmax of GS-2426
大体时间：Predose and postdose up to end of treatment (up to 105 weeks)
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Tmax is defined as the time to peak plasma drug concentration of GS-2426.
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Predose and postdose up to end of treatment (up to 105 weeks)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Gilead Study Director、Gilead Sciences
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年6月2日
初级完成 (估计的)
2029年1月1日
研究完成 (估计的)
2029年1月1日
研究注册日期
首次提交
2026年5月15日
首先提交符合 QC 标准的
2026年5月15日
首次发布 (实际的)
2026年5月22日
研究记录更新
最后更新发布 (实际的)
2026年8月3日
上次提交的符合 QC 标准的更新
2026年7月31日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他研究编号
- GH31C101A
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.