A First-in-human Study of RLY-8161 for Treatment of Advanced NRAS-Mutant Melanoma and Other Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 9
研究概览
简要总结
This is a Phase 1 first-in-human, open-label multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of RLY-8161, an NRAS-selective inhibitor, in participants with advanced NRAS-mutant melanoma and other solid tumors.
详细描述
This is a Phase 1 first-in-human, open-label multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of RLY-8161, an NRAS-selective inhibitor, in participants with advanced NRAS-mutant melanoma and other solid tumors. This study consists of 2 parts: dose escalation (Part 1) and dose expansion (Part 2).
Part 1, dose escalation will explore multiple ascending doses of RLY-8161 in participants with any advanced NRAS-mutant solid tumor until maximum tolerated dose is reached or one or more recommended Phase 2 dose (RP2D) is identified.
Part 2, dose expansion will be at the RP2D(s) identified in Part 1 in NRAS-mutant solid tumors.
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
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Histologically confirmed diagnosis of unresectable Stage III or IV melanoma or other solid tumor.
- •Disease is refractory to standard therapy (including targeted therapy), participant is intolerant of standard therapy, or participant has declined standard therapy.
- •Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.
- •One or more documented primary oncogenic NRAS mutation(s).
排除标准
- •Known activating KRAS, HRAS, or BRAF mutation or known alterations in other driver oncogenes.
- •Prior treatment with ERK, MEK, RAF, or RAS targeting agents or any agent whose mechanism of action is to inhibit the RAS-MAPK pathway.
- •For participants with melanoma: lactate dehydrogenase (LDH) >2×ULN.
- •Central nervous system (CNS) metastases that are associated with progressive neurologic symptoms or require ongoing corticosteroids to control the CNS disease.
研究组 & 干预措施
Part 1: RLY-8161 for participants with advanced NRAS-mutant solid tumors
Multiple doses of RLY-8161 for oral administration
干预措施: RLY-8161 (Drug)
Part 2: RLY-8161 for participants with advanced NRAS-mutant solid tumors
Oral doses of RLY-8161 as determined during Part 1 Dose Escalation
干预措施: RLY-8161 (Drug)