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