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Набира участници Фаза 1/2 NCT06618287

A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors

Фаза 1/2 – комбинирано ранно изпитване
Заболявания: Lung Cancer Breast Cancer

Спонсор: Bristol-Myers Squibb

Налично на: БГ
Обобщение
The purpose of this study is to evaluate the safety, tolerability, drug levels, and preliminary efficacy of BMS-986507 combinations in adult participants with advanced solid tumors.
Кой може да участва
Inclusion Criteria * Participants must have at least one measurable lesion per response evaluation criteria in solid tumors. * Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Participants must have a life expectancy of at least 3 months at the time of the first dose. * Group A: Participants must have pathologically confirmed locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or L858R mutation in exon 21, either alone or in combination with other EGFR mutations, which may include T790M in exon 20. Participants with other EGFR mutations (including but not limited to, exon 21 L861Q, exon 18 G719X, and exon 20 S768I mutations, etc.) will also be allowed * Group B: Participants must have pathologically confirmed locally advanced or metastatic NSCLC. * Group C: Participants must have pathologically confirmed locally-advanced, recurrent inoperable, or metastatic TNBC or ER-low, HER2-negative BC. * Group D: Participants must have pathologically confirmed locally-advanced, recurrent inoperable, or metastatic TNBC per ASCO/CAP criteria, based on the most recently analyzed biopsy or another pathology specimen. * Group E: Participants must have pathologically confirmed locally advanced or metastatic NSCLC, not amenable to treatment in curative intent. Exclusion Criteria * Participants must not have any mixed Small Cell Lung Cancer (SCLC) and Non-Small Cell Lung Cancer (NSCLC) histology. * Participants with known mutations in EGFR will be excluded (Group A,B and E). * Participants must not have a history of serious recurrent infections. * Participants must not have a history of severe heart disease. * Other protocol-defined Inclusion/Exclusion criteria apply.
Места на провеждане 9
Австралия (1)
Liverpool Hospital
Liverpool , New South Wales
Abhijit Pal, Site 0027
Канада (1)
Cross Cancer Institute
Edmonton , Alberta
Quincy Chu, Site 0024
Chile (1)
Local Institution - 0105
Valdivia , Los Ríos Region
NOT_YET_RECRUITING
Франция (1)
Local Institution - 0077
Nice , Alpes-Maritimes
WITHDRAWN
Италия (1)
Cro-Irccs
Aviano , Friuli Venezia Giulia
Alessandra Bearz, Site 0034
Нидерландия (1)
Leids Universitair Medisch Centrum
Leiden , South Holland
Egbert Smit, Site 0004
Испания (1)
CHUS - Hospital Clinico Universitario
Santiago de Compostela , A Coruña [La Coruña]
Великобритания (1)
Royal Free Hospital
London , England
Alexa Childs, Site 0030
САЩ (1)
University of Alabama at Birmingham
Birmingham , Alabama
Aakash Desai, Site 0066
Технически детайли
Статус
Набира участници
Фаза
Фаза 1/2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
04.02.2025
Крайна дата
26.02.2031
Регистрационен номер
NCT06618287
Източник
anzctr
Запитване за медицински туризъм

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