The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
220
Administered by SC injection.
Number of Participants with Dose-limiting toxicities (DLTs)
Time frame: Up to day 21
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to approximately 24 months
Number of Participants with Changes in Vital Signs
Time frame: Up to approximately 24 months
Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
Time frame: Up to approximately 24 months
Maximum Serum Concentration (Cmax) of Tarlatamab
Time frame: Up to approximately 12 months
Serum Concentration Prior to Dosing (Ctrough) of Tarlatamab
Time frame: Up to approximately 12 months
Time to Cmax (Tmax) of Tarlatamab
Time frame: Up to approximately 12 months
Area Under the Concentration-time Curve (AUC) of Tarlatamab
Time frame: Up to approximately 12 months
Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time frame: Up to approximately 24 months
Duration of Response (DOR) per RECIST 1.1
Time frame: Up to approximately 24 months
Time to Response (TTR) per RECIST 1.1
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University of Southern California, Norris Comprehensive Cancer Center
Los Angeles, California, United States
RECRUITINGUniversity of Illinois Chicago
Chicago, Illinois, United States
RECRUITINGTrinity Health Saint Joseph Mercy Ann Arbor
Ann Arbor, Michigan, United States
RECRUITINGAvera Cancer Institute
Sioux Falls, South Dakota, United States
RECRUITINGUniversity of Texas MD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGSwedish Cancer Institute
Seattle, Washington, United States
RECRUITINGChris OBrien Lifehouse
Camperdown, New South Wales, Australia
RECRUITINGCalvary Mater Newcastle Hospital
Waratah, New South Wales, Australia
RECRUITINGThe Alfred Hospital
Melbourne, Victoria, Australia
RECRUITINGUniversitair Ziekenhuis Gent
Ghent, Belgium
RECRUITING...and 21 more locations
Time frame: Up to approximately 24 months
Progression-free Survival (PFS) per RECIST 1.1
Time frame: Up to approximately 24 months
Time to Progression per RECIST 1.1
Time frame: Up to approximately 24 months
Time to Subsequent Therapy
Time frame: Up to approximately 24 months
Overall Survival (OS)
Time frame: Up to approximately 24 months
Number of Participants with Anti-tarlatamab Antibody Formation
Time frame: Up to approximately 24 months