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Набира участници Фаза 1 NCT06533059

A Study to Learn About Study Medicine ALTA2618 in Adults With AKT1 E17K-Mutant Solid Tumors

Фаза 1 – тестване на безопасността при малка група хора
Заболявания: Cancer Breast Cancer Endometrial Cancer Metastatic Cancer Advanced Solid Tumor

Спонсор: Alterome Therapeutics, Inc.

Налично на: БГ
Обобщение
The purpose of this study is to characterize the safety and tolerability of ALTA2618 in adults with AKT1 E17K-mutant advanced solid tumors.
Описание
This is an open-label, multicenter, Phase 1/1b study of ALTA2618, a mutant-selective and orally bioavailable AKT1 E17K inhibitor, in adults with AKT1 E17K-mutant solid tumors. This study will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary clinical activity of ALTA2618, and aims to find the best dose. The study consists of two parts: Part 1 - Dose Escalation and Part 1b - Dose Expansion.
Кой може да участва
Inclusion Criteria: * Histologically confirmed diagnosis of a solid tumor malignancy harboring AKT1 E17K mutation identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic test. * Unresectable or metastatic disease * Progressed on, intolerant to, or declined prior standard-of-care therapy (including targeted therapy, if applicable) appropriate to tumor type and stage * Evaluable or measurable disease per RECIST v1.1 * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate organ function. Exclusion Criteria: * Prior treatment with PI3K and/or mTOR inhibitors * Patients known to have KRAS, NRAS, HRAS, or BRAF genomic alterations in their tumor * Known condition that prohibits ability to swallow or absorb an oral medication Other inclusion/exclusion criteria may apply.
Места на провеждане 8
Австралия (1)
Research Site
Blacktown , New South Wales
Франция (1)
Research Site
Caen
Япония (1)
Research Site
Kyoto
Южна Корея (1)
Research Site
Seoul
Испания (1)
Research Site
Barcelona
Taiwan (1)
Research Site
Changhua
Великобритания (1)
Research Site
London
САЩ (1)
Research Site
La Jolla , California
Технически детайли
Статус
Набира участници
Фаза
Фаза 1
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
22.08.2024
Крайна дата
29.12.2027
Регистрационен номер
NCT06533059
Източник
anzctr
Запитване за медицински туризъм

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