NCT07077434招募中1 期
A Phase 1 Open-Label, Multi-Center Study to Evaluate Pharmacokinetics, Safety and Tolerability of Navlimetostat (BMS-986504) in Japanese and Chinese Participants With Advanced Solid Tumors With Homozygous MTAP Deletion
Bristol-Myers Squibb22 个研究点 分布在 2 个国家目标入组 32 人开始时间: 2025年10月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 22
- 主要终点
- Maximum Plasma Concentration (Cmax) of BMS-986504
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and drug levels of Navlimetostat (BMS-986504) in participants with advanced solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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 must have histologically confirmed diagnosis of a solid tumor malignancy with homozygous MTAP deletion or MTAP loss detected in tumor tissue by a Sponsor-provided central test or a Sponsor pre-approved local test.
- •Participants must have unresectable or metastatic disease not amenable to curative therapies after progression on prior therapies at the time of enrollment.
- •Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Participants must have presence of at least one measurable tumor lesion per RECIST 1.1 at baseline.
排除标准
- •Participants must not have prior treatment with a Protein arginine methyltransferase 5 (PRMT5) or Methionine adenosyltransferase 2A (MAT2A) inhibitor.
- •Participants must not have active brain metastases or carcinomatous meningitis.
- •Participants must not have a history of gastrointestinal disease or other gastrointestinal conditions (e.g., uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study treatment or result in inability to swallow oral medications.
- •Participants must not have known severe hypersensitivity to study treatment and/or any of its excipients.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
BMS-986504 Arm
Experimental
干预措施: BMS-986504 (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax) of BMS-986504
时间窗: Up to approximately Day 64
Time to Reach Maximum Plasma Concentration (Tmax) of BMS-986504
时间窗: Up to approximately Day 64
Area Under Curve (AUC) of BMS-986504
时间窗: Up to approximately Day 64
Mean Elimination Half-life (T-HALF) of BMS-986504
时间窗: Up to approximately Day 64
Apparent Total Body Clearance (CLT/F) of BMS-986504
时间窗: Up to approximately Day 64
Apparent Volume of Distribution During the Terminal Phase (Vz/F) of BMS-986504
时间窗: Up to approximately Day 64
次要结局
- Number of Participants With all-cause AEs(Up to approximately 28 days after last dose of BMS-986504)
- Number of Participants With Dose-limiting Toxicities (DLTs)(Up to approximately Day 25)
- Number of Participants With Treatment-related Adverse Events (AE)(Up to approximately 28 days after last dose of BMS-986504)
- Number of Participants With Treatment-related Serious AEs (SAEs)(Up to approximately 28 days after last dose of BMS-986504)
- Number of Participants With all-cause SAEs(Up to approximately 28 days after last dose of BMS-986504)
- Number of Participants With AEs Leading to Dose Interruption(Up to approximately 28 days after last dose of BMS-986504)
- Number of Participants With AEs Leading to Dose Reduction(Up to approximately 28 days after last dose of BMS-986504)
- Number of Participants With AEs Leading to Treatment Discontinuation(Up to approximately 28 days after last dose of BMS-986504)
- Number of Participants With AEs Leading to Death(Up to approximately 28 days after last dose of BMS-986504)
- Number of Participants With Laboratory Abnormalities(Up to approximately 28 days after last dose of BMS-986504)
研究者
研究点 (22)
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