Actively Recruiting
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
Led by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Updated on 2025-07-30
204
Participants Needed
39
Research Sites
144 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years with an ECOG performance status of 0 to 1 and life expectancy of at least 3 months
- Histopathologically confirmed unresectable locally advanced, recurrent or metastatic HER2-positive gastroesophageal adenocarcinoma
- HER2 expression confirmed as Immunohistochemistry (IHC) 3+ or IHC 2+ with In Situ Hybridization (ISH) positivity
- Ability to provide prior compliant PD-L1 expression test results or sufficient tumor tissue for PD-L1 testing
- No prior systemic therapy for locally advanced or metastatic gastric cancer, or tumor recurrence/metastasis at least 6 months after prior adjuvant/neoadjuvant therapy
- At least one measurable lesion according to RECIST 1.1 criteria
- Adequate function of main organs
- Willingness to use effective contraception during the study and for at least 6 months after last dose
You will not qualify if you...
- Having a concurrent secondary malignancy or other malignancy without disease evidence for more than 5 years
- Uncontrollable toxic reactions above grade 1 due to prior therapy, excluding alopecia
- Major surgery, incisional biopsy, significant injury, unhealed wound or fracture within 28 days prior to first dose
- History or current interstitial lung disease or pneumonia requiring steroids
- Arterial or venous thrombotic events within 6 months prior to first dose
- History of psychiatric drug abuse or mental disorders preventing quitting
- Presence of any severe or uncontrolled disease
- Recent treatment with other antitumor drugs within 4 weeks or proprietary Chinese medicine with antitumor indication within 2 weeks prior to first dose
- Hemorrhagic or bleeding events of grade 3 or higher in the month before study
- Known central nervous system metastases or carcinomatous meningitis
- Severe bone damage or spinal cord compression from tumor bone metastases
- History of live attenuated vaccination within 28 days prior to first dose or planned during study
- Severe hypersensitivity to study drugs or their components
- Active autoimmune disease requiring systemic therapy within 2 years prior to first dose
- Immunodeficiency or ongoing immunosuppressive therapy within 2 weeks prior to study
- Participation in other anti-tumor clinical trials within 4 weeks prior to first medication
- Unstable or serious concurrent medical conditions increasing risk-benefit ratio
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 39 locations
1
Fuyang Cancer Hospital
Fuyang, Anhui, China, 23600
Not Yet Recruiting
2
Lu'an People's Hospital
Lu'an, Anhui, China, 237000
Not Yet Recruiting
3
Maanshan People's Hospital
Maanshan, Anhui, China, 243000
Actively Recruiting
4
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Not Yet Recruiting
5
The first affiliated hospital of chongqing medical university
Chongqing, Chongqing Municipality, China, 400016
Not Yet Recruiting
6
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350014
Not Yet Recruiting
7
Gansu Prouincial Cancer Hospital
Lanzhou, Gansu, China, 730000
Not Yet Recruiting
8
Gansu Wuwei Tumour Hospital
Wuwei, Gansu, China, 733099
Not Yet Recruiting
9
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Not Yet Recruiting
10
Nanfang Hospital
Guangzhou, Guangdong, China, 510515
Not Yet Recruiting
11
Jiangmen Central Hospital
Jiangmen, Guangdong, China, 529000
Not Yet Recruiting
12
Meizhou People's Hospital
Meizhou, Guangdong, China, 514031
Not Yet Recruiting
13
The Second Affiliated Hospital of Guilin Medical College
Guilin, Guangxi, China, 541004
Not Yet Recruiting
14
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China, 530021
Not Yet Recruiting
15
The first affiliated hospital of hainan medical university
Haikou, Hainan, China, 570102
Not Yet Recruiting
16
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050010
Not Yet Recruiting
17
Tangshan People's Hospital
Tangshan, Hebei, China, 063001
Not Yet Recruiting
18
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081
Not Yet Recruiting
19
Anyang Cancer Hospital
Anyang, Henan, China, 455000
Not Yet Recruiting
20
The 1st Affiliated Hospital of He'nan University of Science and Technology
Luoyang, Henan, China, 471000
Not Yet Recruiting
21
Puyang Oilfield General Hospital
Puyang, Henan, China, 457001
Not Yet Recruiting
22
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450000
Not Yet Recruiting
23
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430023
Not Yet Recruiting
24
Xiangyang Central Hospital
Xiangyang, Hubei, China, 441000
Not Yet Recruiting
25
Hunan Cancer Hospital
Changsha, Hunan, China, 410000
Not Yet Recruiting
26
The Second Xiangya Hospital Of Central South University
Changsha, Hunan, China, 410000
Not Yet Recruiting
27
NanJing Drum Tower Hospital
Nanjing, Jiangsu, China, 210000
Not Yet Recruiting
28
Jiangning Hospital of Nanjing City
Nanjing, Jiangsu, China, 211100
Not Yet Recruiting
29
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China, 225009
Not Yet Recruiting
30
Jilin Cancer Hospital
Changchun, Jilin, China, 130012
Not Yet Recruiting
31
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China, 264000
Not Yet Recruiting
32
Fudan university shanghai cancer center
Shanghai, Shanghai Municipality, China, 200032
Not Yet Recruiting
33
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200120
Not Yet Recruiting
34
Shanxi Cancer hospital
Taiyuan, Shanxi, China, 030000
Not Yet Recruiting
35
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an, Shanxi, China, 710000
Not Yet Recruiting
36
Nanchong Central Hospital
Nanchong, Sichuan, China, 637000
Not Yet Recruiting
37
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300202
Not Yet Recruiting
38
Xinjiang Medical University Affiliated Cancer Hospital
Ürümqi, Xinjiang, China, 810000
Not Yet Recruiting
39
Wenzhou Medical University Affiliated First Hospital
Wenzhou, Zhejiang, China, 325000
Not Yet Recruiting
Research Team
R
Ruihua Xu, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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