CTIS2023-504364-42-00进行中（未招募）1 期
A Phase 1/2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 193 in Combination With IDE397 in Subjects With Advanced MTAP-null Solid Tumors - 20220127
Amgen Inc.0 个研究点目标入组 184 人开始时间: 2024年3月15日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 184
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Evidence of homozygous loss of MTAP (null) and/or MTAP deletion, Presence of advanced/metastatic solid tumor not amenable to curative treatment. For Part 1, MTAP-null or lost MTAP expression solid tumor for which no standard therapy exists. For Part 2, MTAP-null or lost MTAP expression NSCLC with progression after 1 to 2 prior lines of systemic therapy., Able to swallow and retain PO administered study treatment and willing to record adherence to investigational product, Disease measurable as defined by RECIST v1.1, Adequate organ function as defined in the protocol, Archived tumor tissue. Participants without archived tumor tissue available may be allowed to enroll by undergoing tumor biopsy before cycle 1 day 1 dosing.
排除标准
- •Prior treatment with an MAT2A inhibitor or a PRMT5 inhibitor., Radiologic or clinical evidence of spinal cord compression, untreated or symptomatic brain metastases or leptomeningeal disease, Cardiovascular and pulmonary exclusion criteria as defined in the protocol, Gastrointestinal tract disease causing the inability to take PO medication, malabsorption syndrome, requirement for IV alimentation, gastric/jejunal tube feeds, uncontrolled inflammatory gastrointestinal disease (eg, Crohn's disease, ulcerative colitis), History of bowel obstruction, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of study entry., Prior irradiation to > 25% of the bone marrow, Use of prescription medications that are known strong CYP3A4/5 inducers or strong CYP3A4/5 inhibitors within 7 days for CYP3A4/5 inhibitors, 14 days for CYP3A4/5 inducers or 5 half-lives, whichever is longer, prior to any dose of investigational medical product
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