Език: EN EN
← Назад към резултатите
Активно (без набиране) Фаза 1/2 NCT06077877

A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Anticancer Activity of GSK4524101 Alone or With Niraparib in Participants With Solid Tumors

Фаза 1/2 – комбинирано ранно изпитване
Заболявания: Neoplasms

Спонсор: GlaxoSmithKline

Налично на: БГ
Обобщение
The primary purpose of this study is to determine the maximum tolerated dose of GSK4524101 monotherapy (MTD) and GSK4524101 in combination with niraparib (MTDc). The study consists of two parts - Part 1 (Dose Escalation) and Part 2 (Dose Expansion).
Кой може да участва
Inclusion Criteria: * More than or equal to (≥)18 years of age * Eastern cooperative oncology group (ECOG) class 0-2 * Life expectancy of a minimum of 3 month * Participant has histologically diagnosed advanced or metastatic solid tumor and has exhausted all standard of care treatment options (Part 1). * Participant has metastatic, gBRCAmut, HER2-negative or HER2-low breast cancer who has completed at most 3 or more prior lines of therapy (Part 2). Exclusion Criteria: * Participant has not recovered (i.e., to Grade less than or equal to \[≤1\] or to baseline) from prior chemotherapy-induced AEs. * Participant is currently participating in a treatment study or has participated in a study of any investigational agent within 4 weeks of the first dose of treatment. * Participant has symptomatic uncontrolled brain or leptomeningeal metastases. * Participant has a known additional malignancy that progressed or required active treatment within the last 2 years * Participant has a known history of Myelodysplastic syndrome (MDS) or Acute myeloid leukemia (AML). * Participant has uncontrolled hypertension with sustained systolic blood pressure (BP) \>140 millimetres of mercury (mmHg) or diastolic BP \>90 mmHg.
Интервенции
GSK4524101
DRUG
Niraparib
DRUG
Места на провеждане 11
Канада (3)
GSK Investigational Site
Edmonton , Alberta
GSK Investigational Site
Montreal , Quebec
GSK Investigational Site
Toronto , Ontario
Panama (2)
GSK Investigational Site
Panama City
GSK Investigational Site
Punta Pacifica Panama City Panama
САЩ (6)
GSK Investigational Site
Dallas , Texas
GSK Investigational Site
Fairfax , Virginia
GSK Investigational Site
Houston , Texas
GSK Investigational Site
San Antonio , Texas
GSK Investigational Site
San Francisco , California
GSK Investigational Site
St Louis , Missouri
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 1/2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
24.10.2023
Крайна дата
30.06.2026
Регистрационен номер
NCT06077877
Източник
clinicaltrials.gov
Запитване за медицински туризъм

Информацията е извлечена автоматично от ClinicalTrials.gov. Консултирайте се с вашия лекар преди да предприемете действия.