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Recruiting Phase 1 NCT06598306

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

Phase 1 – testing safety in a small group of people
Conditions: Extensive Stage Small Cell Lung Cancer

Sponsor: Amgen

trial.available_in: БГ
Overview
The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab.
Who can participate
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.
Locations 10
Australia (1)
Chris OBrien Lifehouse
Camperdown , New South Wales
Belgium (1)
Universitair Ziekenhuis Gent
Ghent
China (1)
Shanghai Pulmonary Hospital
Shanghai , Shanghai Municipality
Germany (1)
Universitaetsklinikum Regensburg
Regensburg
Japan (1)
Okayama University Hospital
Okayama , Okayama-ken
Poland (1)
Uniwersyteckie Centrum Kliniczne
Gdansk
Spain (1)
Hospital Regional Universitario de Malaga
Málaga , Andalusia
Switzerland (1)
Kantonsspital Graubuenden
Chur
Turkey (1)
Adana Sehir Egitim ve Arastirma Hastanesi
Adana
United States (1)
University of Southern California, Norris Comprehensive Cancer Center
Los Angeles , California
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
07.10.2024
Completion date
27.03.2030
Registry ID
NCT06598306
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.