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A Clinical Trial Evaluating TQB2102 for Injection in Combination With Behmosubaisumab/Payamprolizumab With or Without Chemotherapy in Unresectable Locally Advanced, Recurrent, or Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Gastroesophageal Adenocarcinoma

StatusRecruiting
PhasePhase 2
Started2024-11-21
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 30, 2025 (before its estimated September 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2025-07-28
notable
Not Yet Recruiting→Recruiting Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-02→confirmed 2024-11-21
Enrollment target168→204
Study sites36→39
Study arms2→3
InterventionsTQB2102 for injection+Benmelstobart (Drug), TQB2102 for injection+Benmelstobart+Chemotherapy (Drug)→TQB2102 for injection (6 mg/7.5 mg) +Benmelstobart+Chemotherapy (Drug), TQB2102 for injection (6 mg/7.5 mg) +Penpulimab+Chemotherapy…
2025-02-11
minor
Study Identification, Study Status, Arms and Interventions v1
InterventionsTQB2102 for injection+Benmelstobart (Drug), TQB2102 for injection+Benmelstobart+Capecitabine (Drug)→TQB2102 for injection+Benmelstobart (Drug), TQB2102 for injection+Benmelstobart+Chemotherapy (Drug)
Study title+7 characters
A Clinical Trial Evaluating TQB2102 for Injection in Combination With BenmelstobartBehmosubaisumab/PenpulimabPayamprolizumab With or Without CapecitabineChemotherapy in Unresectable Locally Advanced, Recurrent, or Metastatic [...]
2025-01-06
minor
Original filing
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
Trial Details
NCT Number NCT06767800
Lead Sponsor Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Conditions Gastroesophageal Adenocarcinoma
Enrollment 204 participants
Start Date 2024-11-21
Primary Completion 2026-09 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2025-07-30