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
• Status: Recruiting
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Small Cell Lung Carcinoma

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

External Links

•   AmgenTrials clinical trials website