A Phase 1 Study to Evaluate the Mass Balance, Metabolism, Excretion, and Pharmacokinetics of [14C]-BMS-986504 (MRTX1719) in Patients With Advanced Solid Tumors With Homozygous MTAP Deletion
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 8
- 试验地点
- 4
- 主要终点
- Maximum observed concentration (Cmax)
研究概览
简要总结
The purpose of this study is to evaluate the mass balance, metabolism, elimination, and drug levels of [14C]-BMS-986504 (MRTX1719) in participants with advanced solid tumors with homozygous methylthioadenosine phosphorylase deletion.
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 an advanced, unresectable, or metastatic solid tumor malignancy with a deletion of the methylthioadenosine phosphorylase (MTAP) gene.
- •Participants must have received, be refractory to, be ineligible for, or be intolerant of available standard care for their cancer.
排除标准
- •Participants must not have a history of any surgical or medical conditions possibly affecting how the study drug is distributed, broken down (metabolized) and removed (excreted or eliminated) from the body.
- •Participants must not have participated in a clinical study involving a radiolabeled study drug within 12 months prior to admission to the research center.
- •Participants must not have a current or recent (within 3 months of study drug administration) gastrointestinal disease.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
[14C]-BMS-986504 followed by BMS-986504 Monotherapy
Part A: Participants will receive a single oral dose of radiolabeled [14C]-BMS-986504 on C1D1.
Part B: Participants will receive non-radiolabeled BMS-986504, starting from C1D1 and until criteria for treatment discontinuation are met.
干预措施: [14C]-BMS-986504 (Drug)
[14C]-BMS-986504 followed by BMS-986504 Monotherapy
Part A: Participants will receive a single oral dose of radiolabeled [14C]-BMS-986504 on C1D1.
Part B: Participants will receive non-radiolabeled BMS-986504, starting from C1D1 and until criteria for treatment discontinuation are met.
干预措施: BMS-986504 (Drug)
结局指标
主要结局
Maximum observed concentration (Cmax)
时间窗: Up to 2 weeks
Time of maximum observed drug concentration (Tmax)
时间窗: Up to 2 weeks
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
时间窗: Up to 2 weeks
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
时间窗: Up to 2 weeks
Terminal elimination half-life (T-HALF)
时间窗: Up to 2 weeks
Apparent total body clearance (CLT/F)
时间窗: Up to 2 weeks
Apparent volume of distribution during the terminal phase (Vz/F)
时间窗: Up to 2 weeks
Percentage of estimated part for the calculation of AUC(INF) (%AUC(INF))
时间窗: Up to 2 weeks
Blood-to-plasma total radioactivity (TRA) ratio
时间窗: Up to 2 weeks
Total amount of administered dose recovered in urine (UR)
时间窗: Up to 2 weeks
Percent of administered dose recovered in urine (%UR)
时间窗: Up to 2 weeks
Renal clearance (CLR) in urine
时间窗: Up to 2 weeks
Total radioactivity in UR
时间窗: Up to 2 weeks
Total radioactivity in %UR
时间窗: Up to 2 weeks
Total radioactivity in total amount of administered dose recovered in feces (FR)
时间窗: Up to 2 weeks
Total radioactivity in percent of administered dose recovered in feces (%FR)
时间窗: Up to 2 weeks
Total amount of radioactivity recovered (Rtotal)
时间窗: Up to 2 weeks
Total percent of radioactivity recovered (%TOTAL)
时间窗: Up to 2 weeks
TRA amount recovered and fraction of the radioactive dose in vomit if applicable
时间窗: Up to 2 weeks
次要结局
- Number of participants with adverse events (AEs)(Up to 2 years)
- Number of participants with serious adverse events (SAEs)(Up to 2 years)
- Number of participants with AEs leading to discontinuation(Up to 2 years)
- Number of participants with drug-related AEs(Up to 2 years)
- Number of participants with laboratory abnormalities(Up to 2 years)
- Number of deaths(Up to 2 years)