Health Trials

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

ConditionGastroesophageal Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

About this trial

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

Eligibility criteria

Qualifiers

18 to 75 years of age, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, and life expectancy≥3 months;

Histopathologically confirmed unresectable locally advanced, recurrent or metastatic HER2-positive gastroesophageal adenocarcinoma;

HER2 expression levels of Immunohistochemistry(IHC) 3+ or IHC 2+ and In Situ Hybridization (ISH) positivity were confirmed in tumor tissue;

Subject is able to provide previous compliant PD-L1 expression level test results or is able to provide sufficient and competent tumor tissue for PD-L1 expression level testing;

Disqualifiers

Concurrent secondary malignancy. or other malignancy with no evidence of disease for more than 5 years;

Uncontrollable toxic reactions above CTC AE grade 1 due to any prior therapy, excluding alopecia;

Major surgical treatment, incisional biopsy or significant traumatic injury or prolonged unhealed wound or fracture within 28 days prior to first dose;

Prior history of interstitial lung disease/pneumonia (non-infectious) requiring steroidal drug intervention or current concomitant (or suspected) interstitial lung disease/pneumonia;

Trial design

Treatments tested in this trial

  • TQB2102 for injection (7.5 mg) +Benmelstobart+Chemotherapy
  • TQB2102 for injection (6 mg/7.5 mg) +Benmelstobart+Chemotherapy
  • TQB2102 for injection (6 mg/7.5 mg) +Penpulimab+Chemotherapy

Treatment groups

204 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov