A Study 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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат BMS-986504
  Specified dose on specified days
• Препарат [14C]-BMS-986504
  Specified dose on specified days

Первичные конечные точки

• Maximum observed concentration (Cmax) [Срок оценки: Up to 2 weeks]
• Time of maximum observed drug concentration (Tmax) [Срок оценки: Up to 2 weeks]
• Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) [Срок оценки: Up to 2 weeks]
• Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) [Срок оценки: Up to 2 weeks]
• Terminal elimination half-life (T-HALF) [Срок оценки: Up to 2 weeks]
• Apparent total body clearance (CLT/F) [Срок оценки: Up to 2 weeks]
• Apparent volume of distribution during the terminal phase (Vz/F) [Срок оценки: Up to 2 weeks]
• Percentage of estimated part for the calculation of AUC(INF) (%AUC(INF)) [Срок оценки: Up to 2 weeks]
• Blood-to-plasma total radioactivity (TRA) ratio [Срок оценки: Up to 2 weeks]
• Total amount of administered dose recovered in urine (UR) [Срок оценки: Up to 2 weeks]

Вторичные конечные точки (6)

• Number of participants with adverse events (AEs) [Срок оценки: Up to 2 years]
• Number of participants with serious adverse events (SAEs) [Срок оценки: Up to 2 years]
• Number of participants with AEs leading to discontinuation [Срок оценки: Up to 2 years]
• Number of participants with drug-related AEs [Срок оценки: Up to 2 years]
• Number of participants with laboratory abnormalities [Срок оценки: Up to 2 years]
• Number of deaths [Срок оценки: Up to 2 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 2 центра

• START Rioja, The START Center for cancer research — Logroño
• Centro Integral Oncologico Clara Campal-Hospital HM Universitario Sanchinarro-START Madrid — Madrid

Венгрия · 1 центр

• ICON / PRA Magyarország Kft. Fázis I-es Klinikai Farmakológiai Vizsgálóhely — Budapest

Идентификаторы

NCT: NCT06672523 · CA240-0008

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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