A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311)
Summary
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.
Arms & interventions
- DrugTarlatamab
Administered as an IV infusion.
- DrugAB248
Administered either as an IV infusion followed by a flush or using a syringe pump without a flush.
Outcome measures
Primary
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
Secondary
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
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
Eligibility criteria
Study locations (13)
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
University of Southern California, Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Moffitt Cancer Center
Tampa, Florida, 33612
Emory University
Atlanta, Georgia, 30322
Norton Cancer Institute - Downtown
Louisville, Kentucky, 40202-1703
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Siteman Cancer Center
St Louis, Missouri, 63110
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, 19107
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
Baptist Cancer Center
Memphis, Tennessee, 38120
Swedish Cancer Institute Medical Oncology
Seattle, Washington, 98109