Идёт набор NCT07077434

A Study to Assess Safety, Tolerability and Drug Levels of Navlimetostat (BMS-986504) in Participants With Advanced Solid Tumors

Фаза I С лечением Advanced Solid Tumors

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: BMS-986504.
Кому может быть актуально: Состояния в реестре: Advanced Solid Tumors. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Китай, Япония
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

The purpose of this study is to evaluate the safety, tolerability and drug levels of Navlimetostat (BMS-986504) in participants with advanced solid tumors.

Вмешательства

Препарат BMS-986504
Specified dose on specified days

Первичные конечные точки

Maximum Plasma Concentration (Cmax) of BMS-986504 [Срок оценки: Up to approximately Day 64]
Time to Reach Maximum Plasma Concentration (Tmax) of BMS-986504 [Срок оценки: Up to approximately Day 64]
Area Under Curve (AUC) of BMS-986504 [Срок оценки: Up to approximately Day 64]
Mean Elimination Half-life (T-HALF) of BMS-986504 [Срок оценки: Up to approximately Day 64]
Apparent Total Body Clearance (CLT/F) of BMS-986504 [Срок оценки: Up to approximately Day 64]
Apparent Volume of Distribution During the Terminal Phase (Vz/F) of BMS-986504 [Срок оценки: Up to approximately Day 64]

Вторичные конечные точки (10)

Number of Participants With Dose-limiting Toxicities (DLTs) [Срок оценки: Up to approximately Day 25]
Number of Participants With Treatment-related Adverse Events (AE) [Срок оценки: Up to approximately 28 days after last dose of BMS-986504]
Number of Participants With all-cause AEs [Срок оценки: Up to approximately 28 days after last dose of BMS-986504]
Number of Participants With Treatment-related Serious AEs (SAEs) [Срок оценки: Up to approximately 28 days after last dose of BMS-986504]
Number of Participants With all-cause SAEs [Срок оценки: Up to approximately 28 days after last dose of BMS-986504]
Number of Participants With AEs Leading to Dose Interruption [Срок оценки: Up to approximately 28 days after last dose of BMS-986504]
Number of Participants With AEs Leading to Dose Reduction [Срок оценки: Up to approximately 28 days after last dose of BMS-986504]
Number of Participants With AEs Leading to Treatment Discontinuation [Срок оценки: Up to approximately 28 days after last dose of BMS-986504]
Number of Participants With AEs Leading to Death [Срок оценки: Up to approximately 28 days after last dose of BMS-986504]
Number of Participants With Laboratory Abnormalities [Срок оценки: Up to approximately 28 days after last dose of BMS-986504]

Критерии участия

Критерии включения

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 1.
Participants must have presence of at least one measurable tumor lesion per RECIST 1.1 at baseline.

Критерии исключения

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.

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

Здоровые добровольцы: Нет