NCT06767800

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 204 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Gastroesophageal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	TQB2102 for injection (7.5 mg) +Benmelstobart+Chemotherapy	TQB2102 for injection is an antibody-coupled drug Benmelstobart is a Programmed cell death -Ligand 1 (PD-L1) Antibody
DRUG	TQB2102 for injection (6 mg/7.5 mg) +Benmelstobart+Chemotherapy	TQB2102 for injection is an antibody-coupled drug Benmelstobart is a PD-L1 Antibody
DRUG	TQB2102 for injection (6 mg/7.5 mg) +Penpulimab+Chemotherapy	TQB2102 for injection is an antibody-coupled drug

Timeline

• Start date: 2024-11-21
• Primary completion: 2026-09-01
• Completion: 2027-09-01
• First posted: 2025-01-10
• Last updated: 2025-07-30

Locations

39 sites across 1 country: China