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
NCT06767800 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 204
Last updated 2025-07-30
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
- 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
Sponsors & Collaborators
-
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-11-21
- Primary Completion
- 2026-09-30
- Completion
- 2027-09-30
Countries
- China
Study Locations
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