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ACTIVE NOT RECRUITING

NCT03319940

PHASE1

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

Sponsor: Amgen

View on ClinicalTrials.gov

Summary

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

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

269

Start Date

2017-12-26

Completion Date

2027-12-31

Last Updated

2025-11-19

Healthy Volunteers

Conditions

Small Cell Lung Carcinoma

Interventions

DRUG

Tarlatamab

Tarlatamab is a Half-Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3)

DRUG

Pembrolizumab

Pembrolizumab is a potent humanized IgG4 monoclonal antibody (mAb) with high specificity of binding to the PD-1 receptor, thus inhibiting its interaction with PD-L1 and PD-L2

DRUG

CRS Mitigation Strategies

Participants will be treated with one of the CRS mitigation strategies.

Inclusion Criteria: * Participant has provided informed consent prior to initiation of any study-specific activities/procedures * Age greater than or equal to 18 years old at the time of signing the informed consent * Histologically or cytologically confirmed SCLC. For parts A, C, D, E, F, and G: relapsed/refractory small cell lung cancer (R/R SCLC) who progressed or recurred following platinum-based regimen * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Participants with treated brain metastases are eligible provided they meet defined criteria * Adequate organ function as defined in protocol Exclusion Criteria: * History of other malignancy within the past 2 years prior to first dose of tarlatamab with exceptions * Major surgery within 28 days of first dose tarlatamab * Untreated (includes new lesions or progression in previously treated lesions) or symptomatic brain metastases and leptomeningeal disease (regardless of symptomatic or not). * Prior anti-cancer therapy: at least 28 days must have elapsed between any prior anti-cancer therapy and first dose of tarlatamab with the following exceptions: participants who received conventional chemotherapy are eligible if at least 14 days have elapsed and if all treatment-related toxicity has been resolved to Grade less than or equal to 1; and prior palliative radiotherapy must have been completed at least 7 days before the first dose of tarlatamab * Participants who experienced severe, life-threatening or recurrent (Grade 2 or higher) immune-mediated AEs or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immune-oncology agents * Has evidence of interstitial lung disease or active, non-infectious pneumonitis * Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of tarlatamab * Part C only: history of solid organ transplantation or active autoimmune disease that has required systemic treatment within the past 2 years * Participant with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of investigational product administration

Locations (39)

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

St 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

Würzburg, 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, Wakayama, Japan

Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis

Amsterdam, Netherlands

Maastricht Universitair Medisch Centrum

Maastricht, Netherlands

Biokinetica SA

Józefów, Poland

Europejskie Centrum Zdrowia Otwock Szpital imienia Fryderyka Chopina

Otwock, Poland

Hospital Universitari Vall d Hebron

Barcelona, Catalonia, Spain

Hospital Clinic i Provincial de Barcelona

Barcelona, Catalonia, 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 City, Taiwan

Tri-Service General Hospital

Taipei, Taiwan

Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation

Taoyuan District, Taiwan

Christie Hospital

Manchester, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (39)