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Идёт набор NCT06678659

A Study of REC-1245 in Participants With Unresectable, Locally Advanced, or Metastatic Cancer

Фаза I / Фаза II С лечением Unresectable Locally Advanced Metastatic Cancers Relapsed/Refractory Lymphomas

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: REC-1245.
Кому может быть актуально
Состояния в реестре: Unresectable, Locally Advanced, Metastatic Cancers, Relapsed/Refractory Lymphomas. Базовые параметры: от 12 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, Канада
Следующий шаг
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Официальное название

A Phase 1 / 2, Open-Label Study of REC-1245 in Participants With Unresectable, Locally Advanced, or Metastatic Cancer

Обзор

This is a multi-center, open-label study to investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary activity of REC-1245 administered orally on a once daily (QD) schedule in participants with unresectable, locally advanced, or metastatic solid tumors.

Подробное описание

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of REC-1245 for the treatment of participants with unresectable locally advanced or metastatic solid tumors. Participants will receive treatment with REC-1245 for up to 2 years.

Вмешательства

  • Препарат REC-1245
    Oral

Первичные конечные точки

  • Phase 1-Part 1A (Dose Finding)- Number of Participants With Dose Limiting Toxicities (DLTs) [Срок оценки: Initiation of study drug through 4 weeks]
  • Phase 1 and 2 - Number of Participants With a Treatment-emergent Adverse Event [Срок оценки: Initiation of study drug through 30 days after the last dose (up to approximately 24 months)]
  • Phase 2- Objective Response Rate (ORR) [Срок оценки: Initiation from study drug until disease progression (up to approximately 24 months)]
Вторичные конечные точки (11)
  • Phase 1- ORR [Срок оценки: Initiation from study drug until disease progression (up to approximately 24 months)]
  • Phase 1 and 2- Disease Control Rate (DCR) [Срок оценки: Initiation from study drug until disease progression as applicable (up to approximately 24 months)]
  • Phase 1 and 2 - Duration of Response (DOR) [Срок оценки: Initiation from study drug until disease progression as applicable (up to approximately 24 months)]
  • Phase 1 and 2 - Duration of Stable Disease (SD) [Срок оценки: Initiation from study drug until disease progression as applicable (up to approximately 24 months)]
  • Phase 1 and 2 - Time to Response (TTR) [Срок оценки: Initiation from study drug until disease progression as applicable (up to approximately 24 months)]
  • Phase 1 and 2 - Progression Free Survival (PFS) [Срок оценки: Initiation from study drug until disease progression as applicable (up to approximately 24 months)]
  • Phase 1 and 2 - Overall Survival (OS) [Срок оценки: Initiation from study drug until disease progression as applicable (up to approximately 24 months)]
  • Phase 1 - Maximum Plasma Concentration (Cmax) [Срок оценки: Initiation of study drug through Week 9]
  • Phase 1 - Time to Reach Maximum Plasma Concentration (Tmax) [Срок оценки: Initiation of study drug through Week 9]
  • Phase 1 - Plasma Concentration Before the Next Dose (Ctrough) [Срок оценки: Initiation of study drug through Week 9]
  • Phase 1 - Area Under Plasma Concentration-time Curve (AUC) [Срок оценки: Initiation of study drug through Week 9]

Критерии участия

Критерии включения

  • Have histologically-confirmed unresectable, locally advanced, or metastatic select solid tumors or select relapsed / refractory lymphoma
  • Have experienced progressive disease, relapsed disease, or be intolerant to at least one established standard systemic anti-cancer treatment for a given tumor type, or have been considered ineligible for standard therapy.
  • Eastern cooperative oncology group (ECOG) performance status ≤1; for adolescent participants, Lansky Performance Status Scale or Karnofsky Performance Status Scale score of ≥70.
  • Measurable disease at baseline per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 / Lugano criteria and documented by computed tomography (CT) and / or magnetic resonance imaging (MRI)

Критерии исключения

  • Received treatment with another RBM39 degrader
  • Clinically significant gastrointestinal (GI) or GI malabsorption

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 4 центра
  • City of Hope — Duarte
  • Cleveland Clinic — Cleveland
  • SCRI Oncology Partners - PPDS — Nashville
  • START Mountain Region — West Valley City
Канада · 2 центра
  • Princess Margaret Cancer Centre — Toronto
  • McGill University Health Centre (MUHC) - The Montreal — Québec

Идентификаторы

NCT: NCT06678659 · REC-1245-101

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗