The primary aim of this study is to evaluate the efficacy of tarlatamab as assessed by objective response rate (ORR) based on blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
IV infusion
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
The Second Affiliated Hospital of Army Medical University, People's Liberation Army
Chongqing, Chongqing Municipality, China
Army Special Medical Center of Peoples Liberation Army
ORR Based on BICR per RECIST 1.1
Time frame: Approximately 24 months
Duration of Response (DOR) Based on BICR per RECIST 1.1
Time frame: Approximately 24 months
Disease Control (DC) Based on BICR per RECIST 1.1
Time frame: Approximately 24 months
Duration of DC Based on BICR per RECIST 1.1
Time frame: Approximately 24 months
Progression-free Survival (PFS) Based on BICR per RECIST 1.1
Time frame: Approximately 24 months
ORR Based on Investigator Assessment per RECIST 1.1
Time frame: Approximately 24 months
DOR Based on Investigator Assessment per RECIST 1.1
Time frame: Approximately 24 months
DC Based on Investigator Assessment per RECIST 1.1
Time frame: Approximately 24 months
Duration of DC Based on Investigator Assessment per RECIST 1.1
Time frame: Approximately 24 months
PFS Based on Investigator Assessment per RECIST 1.1
Time frame: Approximately 24 months
Overall Survival (OS)
Time frame: Approximately 24 months
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Chongqing, Chongqing Municipality, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Jiangmen Central Hospital
Jiangmen, Guangdong, China
Harbin Meidical University Cancer Hospital
Harbin, Heilongjiang, China
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
...and 2 more locations
Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs)
Time frame: Approximately 24 months
Serum Concentration of Tarlatamab
Time frame: Approximately 24 months
Number of Participants with Anti-tarlatamab Antibody Formation
Time frame: Approximately 24 months