Идёт набор NCT06525298

EIS-12656 as Single Agent and in Combination in Patients With Specified Solid Tumors

Фаза I / Фаза II С лечением Advanced Solid Tumor Homologous Recombination Deficiency HRR Deficiency

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: EIS-12656, Olaparib, Trastuzumab deruxtecan.
Кому может быть актуально: Состояния в реестре: Advanced Solid Tumor, Homologous Recombination Deficiency, HRR Deficiency. 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
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 1/2, Open Label Trial to Investigate the Safety, Tolerability, and Preliminary Efficacy of EIS-12656 as Single Agent and in Combination With a Poly-ADP Ribose Polymerase (PARP) Inhibitor or Trastuzumab Deruxtecan (T-DXd), an Antibody Drug Conjugate (ADC), in Participants With Specified Solid Tumors

Обзор

This trial investigates a new drug, EIS-12656, in participants with specified advanced solid tumors carrying pre-specified mutations. The trial consists of a dose escalation part (Phase 1) and a dose expansion part (Phase 2).

Подробное описание

The trial is a Phase 1/2, open label, uncontrolled trial to investigate the safety and preliminary efficacy of EIS-12656 alone or in combination with a PARPi or T-DXd in patients with specified advanced or metastatic solid tumors with homologous recombination deficient (HRD) mutations.

In the Phase 1 dose escalation phase participants will receive ascending doses of EIS-12656 to evaluate the safety and tolerability and to determine an effective and safe dose for the Phase 2 part.

In the Phase 2 dose expansion phase participants will either receive EIS-12656 monotherapy at the recommended Phase 2 dose (RP2D) (Module 1) or EIS-12656 in combination with a PARPi or T-DXd (Modules 2 and 3). The objective is to evaluate the safety and tolerability and anti-tumor activity of EIS-12656 alone or in combination.

Вмешательства

Препарат EIS-12656
EIS-12656 tablets given daily
Препарат Olaparib
as per USPI/SmPC
Препарат Trastuzumab deruxtecan
as per USPI/SmPC

Первичные конечные точки

Number and percentage of participants experiencing treatment-emergent adverse events (TEAEs) [Срок оценки: From screening until end of treatment follow-up (45 days after last dose) (up to 7 months)]
Number and percentage of participants experiencing a dose limiting toxicity (DLT) (dose escalation part only) [Срок оценки: Within 21 days of first dose]

Вторичные конечные точки (6)

Maximum plasma concentration of EIS-12656 (Cmax) [Срок оценки: At pre-defined intervals from pre-dose Day 1 to Day 29]
Area under the curve (AUC0-24) [Срок оценки: At pre-defined intervals from pre-dose Day 1 to Day 29]
Time to maximum concentration (Tmax) [Срок оценки: At pre-defined intervals from pre-dose Day 1 to Day 29]
Overall Response Rate [Срок оценки: From screening to disease progression (approximately 1 year)]
Duration of Response [Срок оценки: From screening to disease progression or death (approximately 1 year)]
Progression Free Survival [Срок оценки: From screening to disease progression or death (approximately 1 year)]

Критерии участия

Критерии включения

Recurrent locally advanced or metastatic solid tumors
Homologous recombination deficient mutations
Progressed on at least on prior line of treatment or intolerant to additional effective standard therapy
Measurable disease (RECIST 1.1 Criteria)
Adequate organ and bone marrow function
ECOG Performance Status 0 or 1
Life expectancy > 3 months