A Phase 1b/2, Subprotocol of DAY101 in Combination With Pimasertib for Patients With Recurrent, Progressive, or Refractory Solid Tumors and MAPK Pathway Aberrations

Day One Biopharmaceuticals, Inc.10 个研究点分布在 2 个国家目标入组 44 人开始时间: 2022年5月2日最近更新: 2025年8月14日

适应症

干预措施

试验速览

阶段: 1 期
状态: 终止
发起方: Day One Biopharmaceuticals, Inc.
入组人数: 44
试验地点: 10
主要终点: Number of participants who will report Treatment emergent adverse events (TEAEs) and serious TEAEs

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a subprotocol of Master Protocol DAY101-102 and is a Phase 1b/2, multi-center, open label subprotocol of participants ≥12 years of age, with recurrent or progressive solid tumors with alterations in the key proteins of the MAPK pathway, such as tumors that harbor RAS or RAF alterations.

*Note: Study concluded as Phase 1b only.

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: 12 Years 至 —（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Signed informed consent by participant ≥12 years of age; either a Consent or an Assent Form will be provided to the patient based on their capacity, local regulations, and guidelines.
•Participants must have a report of histologically confirmed diagnosis of tumor and a concurrent MAPK pathway alteration (genomic alterations in RAS, RAF, MEK, or NF1) obtained through a tumor or liquid biopsy as assessed by genomic sequencing, polymerase chain reaction (PCR), fluorescence in situ hybridization (FISH), or another clinically accepted molecular diagnostic method recognized by local laboratory or regulatory agency
•Participants must have radiographically stable, recurrent or progressive disease that is measurable using the appropriate tumor response criteria eg, (RECIST version 1.1, RANO)
•Archival tumor tissue should be preferably less than 3 years old. If unavailable, a freshly acquired tumor tissue biopsy or liquid biopsy is required
•If brain metastases are present, they must have been previously treated and be stable as assessed by radiographic imaging

排除标准

•Known presence of concurrent activating alterations
•Participants with current evidence or a history of serous retinopathy (SR), retinal vein occlusion (RVO) or ophthalmopathy present at screening or baseline who would be considered at risk for SR or RVO
•Participants who have an unstable neurological condition, despite adequate treatment (eg, uncontrolled seizures)
•Participants with history of acute neurological events (such as intracranial or subarachnoid hemorrhage, stroke, intracranial trauma) within the past 6 months
•History of second malignancy within 3 years prior to study treatment except for curatively treated cervical cancer in situ, non-melanoma skin cancer, or superficial bladder cancer

研究组 & 干预措施

Experimental Arm

Experimental

Tovorafenib plus pimasertib

干预措施: Tovorafenib (Drug)