A study to assess the safety, tolerability, and PK of tarlatamab in participants with SCLC
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)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
269
Tarlatamab is a Half-Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3)
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
Participants will be treated with one of the CRS mitigation strategies.
Number of participants with dose limiting toxicities (DLT) for all indications
Time frame: 6 months
Number of participants with treatment-emergent adverse events (AEs) for all indications
Time frame: 4 years
Number of participants with treatment-related AEs for all indications
Time frame: 4 years
Number of participants with clinically significant changes in vital signs for all indications
Time frame: 4 years
Number of participants with significant changes in electrocardiogram (ECG) for all indications
Time frame: 4 years
Number of participants with significant changes in physical examinations for all indications
Time frame: 4 years
Number of participants with significant changes in clinical laboratory tests for all indications
Time frame: 4 years
Maximum observed concentration (Cmax) following intravenous administration for all indications
Time frame: 4 years
Minimum observed concentration (Cmin) following intravenous administration for all indications
Time frame: 4 years
Area under the concentration-time curve (AUC) over the 2 week dosing interval for all indications
Time frame: 4 years
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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
...and 29 more locations
Accumulation following multiple dosing for all indications
Time frame: 4 years
Half-life (t1/2) following intravenous administration for all indications
Time frame: 4 years
Objective Response (OR) per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Only for parts A, D, E, F, and G
Time frame: 4 years
Duration of Response (DOR) for all indications
Time frame: 4 years
Time to Response (TTR)
Time frame: 4 years
9-month Progression-Free Survival (PFS) for all indications
Time frame: 9 months
9-month Overall Survival (OS) for all indications
Time frame: 9 months