TQB2102 for injection (7.5 mg) +Benmelstobart+Chemotherapy
DrugTQB2102 for injection is an antibody-coupled drug Benmelstobart is a Programmed cell death -Ligand 1 (PD-L1) Antibody
NCT Number: NCT06767800
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
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 2
Fuyang Cancer Hospital, Fuyang, Anhui, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Through study completion, an average of 1 year
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: Baseline up to disease progression or die, an average of 3 year
Defined as the time from first use of TQB2102 to first disease progression or death from any cause
Time frame: Through study completion, an average of 1 year
Defined as the time from first documented response to documented disease progression or death
Time frame: Baseline up to die, an average of 3 year
Overall survival refers to the time from the first treatment to death from any cause
Time frame: Baseline up to 28 days after the last dose
Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Contact information is provided by the study sponsor or research team.
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Industry
Phase II Clinical Trial Evaluating the Efficacy and Safety of TQB2102 for Injection in Chemotherapy With Behmosubstituted Monoclonalb/Pembrolizumab ± Chemotherapy in Patients With Unresectable, Locally Advanced, Recurrent, or Metastatic HER2-Positive Gastroesophageal Adenocarcinoma
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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