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Идёт набор NCT07524322

Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors

Фаза I С лечением Breast Cancer Ovarian Cancer Endometrial Cancer PIK3CA 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: RGT-490.
Кому может быть актуально
Состояния в реестре: Breast Cancer, Ovarian Cancer, Endometrial Cancer, PIK3CA 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
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 1/1b Open-Label, Multicenter, First-in-Human Study Evaluating Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of RGT-490 as a Single Agent in Adult Subjects With Locally Advanced or Metastatic PIK3CA-Mutated Solid Tumors Including HR+/HER2- Breast Cancers

Обзор

This is a phase 1/1b, open-label, multicenter study consisting of sequential parts designed to evaluate the safety, tolerability, and effects pharmacokinetic (PK) profile, and antitumor activity of RGT-490, an investigational oral therapy, in adults with locally advanced or metastatic solid tumors including breast cancer. Participants enrolled in the study have advanced disease that is not amendable to curative treatment and whose tumors harbor alterations in the PI3KCA gene.

Вмешательства

  • Препарат RGT-490
    Oral tablets

Первичные конечные точки

  • Incidence of dose limiting toxicities (DLTs) [Срок оценки: 4 weeks (1 cycle)]
  • Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: Every cycle (4-week cycles) until study discontinuation, approximately 12 months]
Вторичные конечные точки (9)
  • Characterize the Cmax (PK) of RGT-490 monotherapy in Dose Escalation [Срок оценки: First 3 treatment cycles (each cycle is 28 days)]
  • Characterize the Tmax (PK) of RGT-490 monotherapy in Dose Escalation [Срок оценки: First 3 treatment cycles (each cycle is 28 days)]
  • Characterize the AUC (PK) of RGT-490 monotherapy in Dose Escalation [Срок оценки: First 3 treatment cycles (each cycle is 28 days)]
  • Measure PD effects of RGT-490 monotherapy in Dose Escalation and Phase 1b [Срок оценки: First 7 cycles (each cycle is 28 days) and at study discontinuation]
  • Changes in fasting blood glucose [Срок оценки: Approximately every week in Cycle 1 and Cycle 2 (4-week cycle), every 2 weeks in Cycles 3-6 (4-week cycle), and every cycle through end of treatment (4-week cycles), approximately 24 months]
  • Changes in longitudinal glucose metabolism (All Phases) [Срок оценки: Approximately every cycle (4-week cycles) until study discontinuation, approximately 24 months]
  • Assess preliminary efficacy of RGT-490 monotherapy in dose escalation and Phase 1b [Срок оценки: Approximately every 8 weeks until progressive disease, approximately 12 months]
  • Evaluate additional measures of efficacy of RGT-490 [Срок оценки: Approximately every 8 weeks until progressive disease, approximately 36 months]
  • Evaluate additional measures of efficacy of RGT-490 [Срок оценки: Approximately every 8 weeks until progressive disease, approximately 36 months]

Критерии участия

Критерии включения

  • Adults with metastatic or locally advanced, unresectable solid tumors that have progressed on or after at least one available therapy.
  • Presence of one or more documented activating PIK3CA mutation in tumor tissue and/or blood.
  • At least 1 measurable lesion or evaluable disease per RECIST v1.1.
  • An ECOG performance status of 0 or 1.
  • Adequate organ function

Критерии исключения

  • Diabetes mellitus requiring anti-hyperglycemic medication.
  • Prior treatment with PI3Kα inhibitors
  • Symptomatic, untreated, or uncontrolled central nervous system metastases.
  • Receipt of any local or systemic anticancer therapy or investigational anticancer agent within a protocol-defined washout period prior to study treatment.
  • Unresolved clinically significant toxicities from prior anticancer therapy
  • History of a another malignancy within 2 years prior to screening (exception adequately treated cancers).

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 · 5 центров
  • START Los Angeles — Los Angeles
  • The University of Texas MD Anderson Cancer Center — Houston
  • NEXT Houston — Houston
  • NEXT San Antonio — San Antonio
  • NEXT Virginia — Fairfax

Идентификаторы

NCT: NCT07524322 · RGT-490-101

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗