The primary objective for dose exploration and dose expansion is to evaluate the safety and tolerability of tarlatamab in combination with AB248. The primary objective for dose exploration only is to determine the recommended dose for expansion and/or maximum tolerated combination dose (MTCD) of AB248 in combination with tarlatamab.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
380
Administered as an IV infusion.
Administered either as an IV infusion followed by a flush or using a syringe pump without a flush.
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Clinically significant changes in vital signs and clinical laboratory tests will be reported as adverse events.
Time frame: Up to 2.5 years
Dose Exploration: Number of Participants with Dose-limiting Toxicities (DLTs)
Time frame: Up to 35 days
Maximum Serum Concentration (Cmax) of Tarlatamab
Time frame: Up to approximately 21 weeks
Minimum Serum Concentration (Cmin) of Tarlatamab
Time frame: Up to approximately 21 weeks
Area Under the Concentration-time Curve (AUC) of Tarlatamab
Time frame: Up to approximately 21 weeks
Half-life (t1/2) of Tarlatamab
Time frame: Up to approximately 21 weeks
Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time frame: Up to 2.5 years
Duration of Response (DOR) per RECIST 1.1
Time frame: Up to 2.5 years
Time to Response (TTR) per RECIST 1.1
Time frame: Up to 2.5 years
Disease Control (DC) per RECIST 1.1
Time frame: Up to 2.5 years
Progression-free Survival (PFS) per RECIST 1.1
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University of Southern California, Norris Comprehensive Cancer Center
Los Angeles, California, United States
RECRUITINGMoffitt Cancer Center
Tampa, Florida, United States
RECRUITINGEmory University
Atlanta, Georgia, United States
RECRUITINGNorton Cancer Institute - Downtown
Louisville, Kentucky, United States
RECRUITINGDana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGSiteman Cancer Center
St Louis, Missouri, United States
RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITINGSidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States
RECRUITINGAllegheny General Hospital
Pittsburgh, Pennsylvania, United States
RECRUITING...and 9 more locations
Time frame: Up to 2.5 years
Time to Progression (TTP) per RECIST 1.1
Time frame: Up to 2.5 years
Time to Subsequent Therapy
Time frame: Up to 2.5 years
Overall Survival (OS)
Time frame: Up to 2.5 years
Number of Participants with Anti-AB248 Antibody Formation
Time frame: Up to 2.5 years