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Набира участници Фаза 1 NCT06598306

Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)

Фаза 1 – тестване на безопасността при малка група хора
Заболявания: Extensive Stage Small Cell Lung Cancer

Спонсор: Amgen

Налично на: БГ
Обобщение
The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab.
Кой може да участва
Inclusion Criteria: * Participants ≥ 18 years of age (or ≥ legal adult age within country if it is older than 18 years) at time of signing informed consent. * Participants with histologically or cytologically confirmed ES-SCLC that progressed or recurred following at least one line of platinum-based anti-cancer therapy for SCLC. Note: Participants with prior treatment for LS-SCLC should have also received another regimen for their recurrent, ES-SCLC disease. * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1. * Participants must have adequate organ function (cardiac, pulmonary, kidney, and liver). * Participants must be able to have SC injections administered in the abdomen. * Participants without measurable disease or tumor tissue (fresh biopsy or archival) available may be permitted after discussion with and approval by Amgen Medical Monitor. Exclusion Criteria: * Participants that have received prior DLL3 targeted therapy. * Participants with untreated or symptomatic brain metastases or those requiring therapy with steroids. * Note: Participants with asymptomatic brain metastatic lesions are allowed following definitive treatment (Amgen Medical Monitor may approve untreated, asymptomatic brain metastasis if local therapy is not required per investigator judgment). * Participants with leptomeningeal disease. * Participants with baseline oxygen requirement.
Места на провеждане 10
Австралия (1)
Chris OBrien Lifehouse
Camperdown , New South Wales
Белгия (1)
Universitair Ziekenhuis Gent
Ghent
Китай (1)
Shanghai Pulmonary Hospital
Shanghai , Shanghai Municipality
Германия (1)
Universitaetsklinikum Regensburg
Regensburg
Япония (1)
Okayama University Hospital
Okayama , Okayama-ken
Полша (1)
Uniwersyteckie Centrum Kliniczne
Gdansk
Испания (1)
Hospital Regional Universitario de Malaga
Málaga , Andalusia
Швейцария (1)
Kantonsspital Graubuenden
Chur
Турция (1)
Adana Sehir Egitim ve Arastirma Hastanesi
Adana
САЩ (1)
University of Southern California, Norris Comprehensive Cancer Center
Los Angeles , 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
07.10.2024
Крайна дата
27.03.2030
Регистрационен номер
NCT06598306
Източник
anzctr
Запитване за медицински туризъм

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