A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of Subcutaneous Tarlatamab in Subjects With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)
Summary
The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab.
Arms & interventions
- DrugTarlatamab
Administered by SC injection.
Outcome measures
Primary
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
Secondary
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
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
Eligibility criteria
Study locations (6)
University of Southern California, Norris Comprehensive Cancer Center
Los Angeles, California, 90033
University of Illinois Chicago
Chicago, Illinois, 60612
Trinity Health Saint Joseph Mercy Ann Arbor
Ann Arbor, Michigan, 48106
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Swedish Cancer Institute
Seattle, Washington, 98104