TQB2102 for injection is a novel antibody-coupled drug (ADC) that enhances binding to tumor cell surface HER2 proteins by simultaneously targeting the two non-overlapping epitopes of the HER2 protein, Endothelial Cell Dysfunction 2 (ECD2) and Endothelial Cell Dysfunction 4 (ECD4), increasing HER2 internalization, and then down-regulating the tumor cell surface HER2 proteins more effectively, and doubly blocking the HER2 signaling, to achieve the effects of trastuzumab and Pertuzumab alone and in combination. This is a Phase II study to evaluate the efficacy and safety of TQB2102 for injection in combination with Benmelstobart Injection /Penpulimab Injection ± chemotherapy in patients with unresectable locally advanced, recurrent or metastatic HER2-positive gastroesophageal adenocarcinoma
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
204
TQB2102 for injection is an antibody-coupled drug Benmelstobart is a Programmed cell death -Ligand 1 (PD-L1) Antibody
TQB2102 for injection is an antibody-coupled drug Benmelstobart is a PD-L1 Antibody
TQB2102 for injection is an antibody-coupled drug
Fuyang Cancer Hospital
Fuyang, Anhui, China
NOT_YET_RECRUITINGLu'an People's Hospital
Lu'an, Anhui, China
NOT_YET_RECRUITINGMaanshan People's Hospital
Maanshan, Anhui, China
RECRUITINGPeking Union Medical College Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGObjective Response Rate (ORR)
Defined as the percentage of Complete Response (CR) plus partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria and guidelines for response criteria for use in trials testing immunotherapeutics (iRECIST )for solid tumors.
Time frame: Through study completion, an average of 1 year
Progression-free survival (PFS)
Defined as the time from first use of TQB2102 to first disease progression or death from any cause
Time frame: Baseline up to disease progression or die, an average of 3 year
Duration of Response (DOR)
Defined as the time from first documented response to documented disease progression or death
Time frame: Through study completion, an average of 1 year
Overall survival(OS)
Overall survival refers to the time from the first treatment to death from any cause
Time frame: Baseline up to die, an average of 3 year
Number of patients with adverse events (AEs) and serious adverse events (SAEs)
Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: Baseline up to 28 days after the last dose
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The first affiliated hospital of chongqing medical university
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGFujian Cancer Hospital
Fuzhou, Fujian, China
NOT_YET_RECRUITINGGansu Prouincial Cancer Hospital
Lanzhou, Gansu, China
NOT_YET_RECRUITINGGansu Wuwei Tumour Hospital
Wuwei, Gansu, China
NOT_YET_RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGNanfang Hospital
Guangzhou, Guangdong, China
NOT_YET_RECRUITING...and 29 more locations