Идёт набор NCT05490472

JAB-2485 Activity in Adult Patients With Advanced Solid Tumors

Фаза I / Фаза II С лечением Solid Tumors ER+ Breast Cancer Triple Negative Breast Cancer, TNBC ARID1A Gene Mutation

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: JAB-2485 (Aurora A inhibitor), JAB-2485 (Aurora A inhibitor).
Кому может быть актуально: Состояния в реестре: Solid Tumors, ER+ Breast Cancer, Triple Negative Breast Cancer, TNBC, ARID1A Gene Mutation. 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: США, Китай
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 1/2a, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-2485 in Adult Patients With Advanced Solid Tumors

Обзор

This study is to evaluate the safety and tolerability of JAB-2485 monotherapy in adult participants with advanced solid tumors.

Подробное описание

The primary objective of this study is to evaluate the safety and tolerability of JAB-2485 monotherapy to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) during Dose Escalation phase when administered in participants with advanced solid tumors; then to further evaluate preliminary antitumor activity of JAB-2485 monotherapy at the RP2D during Dose Expansion phase in patients with advanced solid tumors such as ER+ breast cancer, triple negative breast cancer (TNBC), AT-rich interaction domain 1A (ARID1A) mutant solid tumors and small cell lung cancer (SCLC).

Вмешательства

Препарат JAB-2485 (Aurora A inhibitor)
Administered orally
Препарат JAB-2485 (Aurora A inhibitor)
Administered orally

Первичные конечные точки

Dose Escalation phase: Number of participants with dose limiting toxicities (DLTs) [Срок оценки: First 21 days of Cycle 1]
Dose Escalation phase: Number of participants with adverse events (AEs) [Срок оценки: Up to 3 years]
Dose Expansion phase: Objective Response Rate (ORR) [Срок оценки: Up to 3 years from baseline to RECIST confirmed Progressive Disease (PD)]
Dose Expansion phase: Duration of Response (DOR) [Срок оценки: Up to 3 years]

Вторичные конечные точки (12)

Dose Escalation phase: Objective Response Rate (ORR) [Срок оценки: Up to 3 years from baseline to RECIST confirmed Progressive Disease (PD)]
Dose Escalation and Dose Expansion phase: Time to response (TTR) [Срок оценки: Up to 3 years]
Dose Escalation phase: Duration of Response (DOR) [Срок оценки: Up to 3 years]
Dose Escalation and Dose Expansion phase: peak plasma concentration (Cmax) [Срок оценки: Up to 3 years]
Dose Escalation and Dose Expansion phase: time to peak plasma concentration(Tmax) [Срок оценки: Up to 3 years]
Dose Escalation and Dose Expansion phase: Ctrough [Срок оценки: Up to 3 years]
Dose Escalation and Dose Expansion phase: Area under the curve (AUC) [Срок оценки: Up to 3 years]
Dose Escalation and Dose Expansion phase: half-life (t½) [Срок оценки: Up to 3 years]
Dose Escalation and Dose Expansion phase: total body clearance [Срок оценки: Up to 3 years]
Dose Expansion phase: Progression Free Survival (PFS) [Срок оценки: Up to 3 years]
Dose Expansion Phase 2a: Overall Survival (OS) [Срок оценки: Up to 3 years]
Dose Expansion phase: Disease Control Rate (DCR) [Срок оценки: Up to 3 years]

Критерии участия

Критерии включения

Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Must be able to provide an archived tumor sample
Must have histologically or cytologically confirmed metastatic or locally advanced solid tumor

Dose Expansion phase cohorts must meet specific expression or gene mutation where indicated
Must be refractory to or become intolerant of existing therapy(ies) known to provide clinical benefit for their condition
Must have at least 1 measurable lesion per RECIST v1.1
Must have adequate organ functions
Must be able to swallow and retain orally administered medication

Критерии исключения

Has central nervous system (CNS) metastases or carcinomatous meningitis, except if CNS metastases treated and no evidence of radiographic progression or hemorrhage for at least 28 days
Active infection requiring systemic treatment within 7 days
Active hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV
Any severe and/or uncontrolled medical conditions
left ventricular ejection fraction (LVEF) ≤50% assessed by echocardiogram (ECHO) or multigated acquisition scan (MUGA)
QT interval using Fridericia's formula (QTcF) interval >470 msec
Experiencing unresolved CTCAE 5.0 Grade >1 toxicities
Clinically significant eye disorders

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

Здоровые добровольцы: Нет