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NCT03319940 Clinical Trial

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

Small Cell Lung Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03319940
Other study ID # 20160323
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date December 26, 2017
Est. completion date October 18, 2025

Study information
Verified date June 2024
Source Amgen
Contact Amgen Call Center
Phone 866-572-6436
Email medinfo@amgen.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility
Status Recruiting
Enrollment 392
Est. completion date October 18, 2025
Est. primary completion date October 18, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Tarlatamab
Tarlatamab is a Half-Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3)
• 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
• CRS Mitigation Strategies
Participants will be treated with one of the CRS mitigation strategies.

Locations
Country Name City State
Australia Chris OBrien Lifehouse Camperdown New South Wales
Austria Medizinische Universitaet Graz Graz
Austria Landeskrankenhaus Salzburg Salzburg
France Gustave Roussy Villejuif
Germany Universitaetsklinikum Wuerzburg Wuerzburg
Hong Kong Prince of Wales Hospital Shatin, New Territories
Japan National Cancer Center Hospital Chuo-ku Tokyo
Japan National Cancer Center Hospital East Kashiwa-shi Chiba
Japan Wakayama Medical University Hospital Wakayama-shi Wakayama
Netherlands Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis Amsterdam
Netherlands Maastricht Universitair Medisch Centrum Maastricht
Poland Biokinetica SA Jozefow
Poland Europejskie Centrum Zdrowia Otwock Szpital imienia Fryderyka Chopina Otwock
Spain Hospital Clinic i Provincial de Barcelona Barcelona Cataluña
Spain Hospital Universitari Vall d Hebron Barcelona Cataluña
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Universitario La Paz Madrid
Spain Hospital Universitario Ramon y Cajal Madrid
Switzerland Centre Hospitalier Universitaire Vaudois Lausanne
Switzerland Kantonsspital St Gallen Sankt Gallen
Taiwan 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
United Kingdom Christie Hospital Manchester
United States Winship Cancer Institute Atlanta Georgia
United States John Hopkins Sidney Kimmel Comprehensive Cancer Center Baltimore Maryland
United States University of Chicago Chicago Illinois
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 Henry Ford Health System Detroit Michigan
United States City of Hope National Medical Center Duarte California
United States Sarah Cannon Research Institute Nashville Tennessee
United States Yale New Haven Hospital New Haven Connecticut
United States Ochsner Clinic Foundation New Orleans Louisiana
United States Memorial Sloan Kettering Cancer Center New York New York
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States University of Pittsburgh Medical Center Cancer Pavillion Pittsburgh Pennsylvania
United States Washington University Saint Louis Missouri
United States Moffitt Cancer Center Tampa Florida

Sponsors (1)
Lead Sponsor Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Australia,  Austria,  France,  Germany,  Hong Kong,  Japan,  Netherlands,  Poland,  Spain,  Switzerland,  Taiwan,  United Kingdom, 

References & Publications (1)

Owen DH, Giffin MJ, Bailis JM, Smit MD, Carbone DP, He K. DLL3: an emerging target in small cell lung cancer. J Hematol Oncol. 2019 Jun 18;12(1):61. doi: 10.1186/s13045-019-0745-2. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with dose limiting toxicities (DLT) for all indications 6 months
Primary Number of participants with treatment-emergent adverse events (AEs) for all indications 4 years
Primary Number of participants with treatment-related AEs for all indications 4 years
Primary Number of participants with clinically significant changes in vital signs for all indications 4 years
Primary Number of participants with significant changes in electrocardiogram (ECG) for all indications 4 years
Primary Number of participants with significant changes in physical examinations for all indications 4 years
Primary Number of participants with significant changes in clinical laboratory tests for all indications 4 years
Secondary Maximum observed concentration (Cmax) following intravenous administration for all indications 4 years
Secondary Minimum observed concentration (Cmin) following intravenous administration for all indications 4 years
Secondary Area under the concentration-time curve (AUC) over the 2 week dosing interval for all indications 4 years
Secondary Accumulation following multiple dosing for all indications 4 years
Secondary Half-life (t1/2) following intravenous administration for all indications 4 years
Secondary Objective Response (OR) per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Only for parts A, D, E, F, and G 4 years
Secondary Duration of Response (DOR) for all indications 4 years
Secondary Time to Response (TTR) 4 years
Secondary 9-month Progression-Free Survival (PFS) for all indications 9 months
Secondary 9-month Overall Survival (OS) for all indications 9 months
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