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Идёт набор NCT06810544

Safety and Tolerability of TNG456 Alone and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss

Фаза I / Фаза II С лечением Non Small Cell Lung Cancer Glioma Glioblastoma Multiforme Glioma, Malignant Solid Tumor

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: TNG456, abemaciclib.
Кому может быть актуально
Состояния в реестре: Non Small Cell Lung Cancer, Glioma Glioblastoma Multiforme, Glioma, Malignant, Solid Tumor. 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
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Официальное название

A Phase 1/2, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Antitumor Activity of TNG456 Monotherapy and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss

Обзор

This is a first in human study of TNG456 alone and in combination with abemaciclib in patients with advanced or metastatic solid tumors known to have an MTAP loss. The first part of the study is an open-label, dose escalation and the second part is an open label dose expansion in specific solid tumor types with a confirmed MTAP loss. The study drug, TNG456, is a selective PRMT5 inhibitor administered orally. The study is planned to treat up to 191 participants.

Подробное описание

This is a Phase 1/2 multi-center, open label study in solid tumor patients who have a confirmed MTAP loss in their tumor. The Phase 1 portion is a dose escalation study of oral TNG456 administered as a single agent and in combination with oral abemaciclib in solid tumor patients with confirmed MTAP loss. In the Phase 2 expansion part of the study, 6 arms defined by confirmed tumor types will enroll in parallel at the RP2D(s) of TNG456 and in combination. In both parts of the study participants who tolerate the drug may continue treatment until disease progression.

Вмешательства

  • Препарат TNG456
    A selective PRMT5 inhibitor
  • Препарат abemaciclib
    A kinase inhibitor

Первичные конечные точки

  • Phase 1 Maximum Tolerated Dose [Срок оценки: 21 days]
  • Phase 2 Anti-neoplastic Activity Single Agent [Срок оценки: 18 weeks]
  • Phase 2 Anti-neoplastic Activity Combination Treatment [Срок оценки: 18 weeks]
Вторичные конечные точки (5)
  • Phase 1 Anti-neoplastic Activity Single Agent [Срок оценки: 18 weeks]
  • Phase 1 and 2 Adverse Event Profile [Срок оценки: 21 days]
  • Phase 1 and 2 Concentration versus Time Curve [Срок оценки: 16 days]
  • Phase 1 and 2 Time to Achieve Maximal Plasma Concentration [Срок оценки: 16 days]
  • Phase 1 and 2 Maximum Observed Plasma Concentration [Срок оценки: 16 days]

Критерии участия

Критерии включения

  • Has a tumor with a confirmed MTAP loss
  • Is ≥18 years of age at the time of signature of the main study ICF
  • Has had progression or an inadequate response to or is intolerant of the approved standard of care therapy, no standard of care therapy exists, or the investigator has determined that treatment with the standard of care therapy is not appropriate.
  • Is able to swallow tablets
  • Adequate Organ function/reserve per local labs
  • Negative serum pregnancy test result at screening
  • Has an ECOG performance status score of 0 to 1
  • Has measurable disease based on RECIST v1.1 or a confirmed glioblastoma (IDH-wildtype) with radiographic evidence of disease progression or recurrence defined by RANO 2.0.
  • Has an ECOG performance score of 0 to 1 or for GBM has a Karnofsky performance status score ≥70.

Критерии исключения

  • A female patient is who is pregnant or breastfeeding
  • Has impaired GI function or disease that may significantly alter the absorption of oral study treatment(s)
  • Has an active infection requiring systemic therapy
  • Has received prior treatment with a PRMT5 inhibitor or a MAT2A inhibitor
  • Patients in the expansion receiving the combination therapy that have received prior treatment with a CDK4/6 inhibitor
  • Clinically relevant cardiovascular disease
  • Has a prior or ongoing clinically significant illness may affect the safety of the patient, impair the assessment of study results or compliance with the protocol

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 15 центров
  • Mayo Clinic Scottsdale — Scottsdale
  • University of California, Irvine — Irvine
  • University of California Los Angeles — Los Angeles
  • University of California at San Francisco — San Francisco
  • Sibley Memorial Hospital — Washington D.C.
  • Mayo Clinic Jacksonville — Jacksonville
  • Northwestern Memorial Hospital — Chicago
  • Dana Farber Cancer Institute — Boston
  • … и ещё 7 центров

Идентификаторы

NCT: NCT06810544 · TNG456-C101

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗