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Spots Global Cancer Trial Database for Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC)

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Trial Identification

Brief Title: Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC)

Official Title: A Phase 1 Study Evaluating the Safety, Tolerability and Pharmacokinetics of Tarlatamab in Subjects With Small Cell Lung Cancer (DeLLphi-300)

Study ID: NCT03319940

Study Description

Brief Summary: A study to assess the safety, tolerability, and PK of tarlatamab in participants with SCLC

Detailed Description: This is an open-label, ascending, multiple doses, phase 1 study evaluating tarlatamab monotherapy, in combination with anti-PD1 therapy and with additional cytokine release syndrome (CRS) mitigation strategies. Tarlatamab will be administered as a short term intravenous (IV) infusion in participants with SCLC. Tarlatamab is a Half-Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3)

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

City of Hope National Medical Center, Duarte, California, United States

Yale New Haven Hospital, New Haven, Connecticut, United States

Moffitt Cancer Center, Tampa, Florida, United States

Winship Cancer Institute, Atlanta, Georgia, United States

University of Chicago, Chicago, Illinois, United States

Ochsner Clinic Foundation, New Orleans, Louisiana, United States

John Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States

Henry Ford Health System, Detroit, Michigan, United States

Washington University, Saint Louis, Missouri, United States

Memorial Sloan Kettering Cancer Center, New York, New York, United States

University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States

The Ohio State University Wexner Medical Center - Thoracic Oncology Clinic, Columbus, Ohio, United States

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center Cancer Pavillion, Pittsburgh, Pennsylvania, United States

Sarah Cannon Research Institute, Nashville, Tennessee, United States

Chris OBrien Lifehouse, Camperdown, New South Wales, Australia

Medizinische Universitaet Graz, Graz, , Austria

Landeskrankenhaus Salzburg, Salzburg, , Austria

Gustave Roussy, Villejuif, , France

Universitaetsklinikum Wuerzburg, Wuerzburg, , Germany

Prince of Wales Hospital, Shatin, New Territories, , Hong Kong

National Cancer Center Hospital East, Kashiwa-shi, Chiba, Japan

National Cancer Center Hospital, Chuo-ku, Tokyo, Japan

Wakayama Medical University Hospital, Wakayama-shi, Wakayama, Japan

Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis, Amsterdam, , Netherlands

Maastricht Universitair Medisch Centrum, Maastricht, , Netherlands

Biokinetica SA, Jozefow, , Poland

Europejskie Centrum Zdrowia Otwock Szpital imienia Fryderyka Chopina, Otwock, , Poland

Hospital Universitari Vall d Hebron, Barcelona, Cataluña, Spain

Hospital Clinic i Provincial de Barcelona, Barcelona, Cataluña, Spain

Hospital Universitario Ramon y Cajal, Madrid, , Spain

Hospital Universitario 12 de Octubre, Madrid, , Spain

Hospital Universitario La Paz, Madrid, , Spain

Centre Hospitalier Universitaire Vaudois, Lausanne, , Switzerland

Kantonsspital St Gallen, Sankt Gallen, , Switzerland

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, , Taiwan

Tri-Service General Hospital, Taipei, , Taiwan

Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation, Taoyuan, , Taiwan

Christie Hospital, Manchester, , United Kingdom

Contact Details

Name: MD

Affiliation: Amgen

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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