RecruitingPhase 1NCT06598306

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

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of Subcutaneous Tarlatamab in Subjects With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)

Sponsor

Amgen

Enrollment

220 participants

Start Date

Oct 7, 2024

Study Type

INTERVENTIONAL

Summary

The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new subcutaneous (under-the-skin injection) form of tarlatamab — an immunotherapy that targets a protein called DLL3 — in patients with extensive-stage small cell lung cancer (ES-SCLC) that has come back or kept growing after platinum-based chemotherapy. **You may be eligible if...** - You are 18 or older - You have confirmed extensive-stage small cell lung cancer - Your cancer progressed or returned after at least one round of platinum-based chemotherapy - You have good functional status (ECOG 0 or 1) - You have adequate heart, lung, kidney, and liver function - You can receive injections in the abdomen **You may NOT be eligible if...** - You have previously received DLL3-targeted therapy - You have untreated or symptomatic brain metastases requiring steroids - You have cancer spreading to the membranes around the brain (leptomeningeal disease) - You require supplemental oxygen at rest Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTarlatamab

Administered by SC injection.

Locations(30)

University of Southern California, Norris Comprehensive Cancer Center

Los Angeles, California, United States

University of Illinois Chicago

Chicago, Illinois, United States

Trinity Health Saint Joseph Mercy Ann Arbor

Ann Arbor, Michigan, United States

Avera Cancer Institute

Sioux Falls, South Dakota, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Swedish Cancer Institute

Seattle, Washington, United States

Chris OBrien Lifehouse

Camperdown, New South Wales, Australia

Calvary Mater Newcastle Hospital

Waratah, New South Wales, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Universitair Ziekenhuis Gent

Ghent, Belgium

Universitair Ziekenhuis Leuven - Campus Gasthuisberg

Leuven, Belgium

Centre Hospitalier Universitaire de Liege - Sart Tilman

Liège, Belgium

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Universitaetsklinikum Regensburg

Regensburg, Germany

Universitaetsklinikum Wuerzburg

Würzburg, Germany

Okayama University Hospital

Okayama, Okayama-ken, Japan

Wakayama Medical University Hospital

Wakayama, Japan

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Instytut Centrum Zdrowia Matki Polki

Lodz, Poland

Wojewodzki Szpital im Sw Ojca Pio w Przemyslu

Przemyśl, Poland

Hospital Regional Universitario de Malaga

Málaga, Andalusia, Spain

Hospital Universitari Vall d Hebron

Barcelona, Catalonia, Spain

Hospital Universitari i Politecnic La Fe

Valencia, Valencia, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Kantonsspital Graubuenden

Chur, Switzerland

Freiburg Spital

Fribourg, Switzerland

Kantonsspital Winterthur

Winterthur, Switzerland

Adana Sehir Egitim ve Arastirma Hastanesi

Adana, Turkey (Türkiye)

Ankara Bilkent Sehir Hastanesi

Ankara, Turkey (Türkiye)

Koc Universitesi Hastanesi

Istanbul, Turkey (Türkiye)

View Full Details on ClinicalTrials.gov

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NCT06598306