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
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 174
- 试验地点
- 4
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: GS-2426 (Drug)
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.
干预措施: GS-2426 (Drug)