Gastroesophageal AdenocarcinomaPhase 2NCT06767800
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
A Phase 2 study testing TQB2102 for injection (7.5 mg) +Benmelstobart+Chemotherapy, TQB2102 for injection (6 mg/7.5 mg) +Benmelstobart+Chemotherapy and TQB2102 for injection (6 mg/7.5 mg) +Penpulimab+Chemotherapy in people with Gastroesophageal Adenocarcinoma, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 39 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastroesophageal Adenocarcinoma
- What is being tested?
- TQB2102 for injection (7.5 mg) +Benmelstobart+Chemotherapy, TQB2102 for injection (6 mg/7.5 mg) +Benmelstobart+Chemotherapy and TQB2102 for injection (6 mg/7.5 mg) +Penpulimab+Chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 39 sitesChina
- Study dates
- 21 Nov 2024to Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- Patients who have not received prior systemic therapy for locally advanced or metastatic gastric cancer and who have experienced tumor recurrence or metastasis at least 6 months after the completion of prior adjuvant or neoadjuvant therapy may be enrolled;
- Confirmation of at least one measurable lesion according to RECIST 1.1 criteria;
- The main organs function well;
- Male or female patient had no plans to become pregnant and voluntarily take effective contraceptive measures from agree with the study to at least 6 months after the last dose of study drug.
Who cannot join
- 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;
- Arterial/venous thrombotic events, such as cerebrovascular accidents, deep vein thrombosis, and pulmonary embolism, have occurred within 6 months prior to the first dose;
- Individuals with a history of psychiatric drug abuse who are unable to quit or have mental disorders;
Show all 16Show fewer
- Subjects with the presence of any severe and/or uncontrolled disease；
- Subjects who have received other antitumor drugs such as chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the first dose, or who are still within the 5 half-life of the drug (whichever occurs shortest); have received a proprietary Chinese medicine with an antitumor indication as specified in the National Medical Products Administration(NMPA) -approved drug insert within 2 weeks prior to the first dose; and have experienced any hemorrhagic or bleeding event in the month prior to the initiation of study treatment ≥CTC Patients with AE grade 3;
- Subjects with known Central nervous system (CNS) metastases and/or carcinomatous meningitis
- Presence of severe bone damage and spinal cord compression due to tumor bone metastases;
- History of live attenuated vaccination within 28 days prior to the first dose or planned live attenuated vaccination during the study;
- History of severe hypersensitivity reactions to large molecule drugs or hypersensitivity to known components of TQB2102, benmelstobart or pembrolizumab for injection;
- Active autoimmune disease requiring systemic therapy (e.g., use of disease-mitigating drugs, corticosteroids, or immunosuppressive agents) within 2 years prior to the first dose of medication
- Diagnosis of immunodeficiency or undergoing systemic glucocorticoid therapy or any other form of immunosuppressive therapy that was continued within 2 weeks prior to initiation of study treatment.
- Participants who have participated in and used other anti-tumor clinical trial drugs within 4 weeks before the first medication use
- Unstable or serious concurrent medical conditions, as assessed by the Investigators, that would substantially increase the risk-benefit ratio of participating in the study.
Trial locations and contacts
39 sites in 1 country. Contact the study team or a site near you to ask about taking part.
39 sites in 1 country
China39 sites, 39 recruiting
- Not yet recruiting
Anyang Cancer Hospital
Anyang, Henan, 455000
Jin Xia, Master, 15890750990, 15890750990@126.com
- Not yet recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Yi Ba, Doctor, 18622221230, bayi@tjmuch.com
- Not yet recruiting
Jilin Cancer Hospital
Changchun, Jilin, 130012
Jingjing Liu, Master, 15948708961, jingjingstone@126.com
- Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410000
Yi He, Doctor, 18692237222, heyi@hnca.org.cn
Zhenyang Liu, Doctor, 18673181133, 1323081926@qq.com
- Not yet recruiting
The Second Xiangya Hospital Of Central South University
Changsha, Hunan, 410000
Yawen Gao, Doctor, 18673194699, 2948390593@qq.com
- Not yet recruiting
The first affiliated hospital of chongqing medical university
Chongqing, Chongqing Municipality, 400016
Jun Zhang, Doctor, 13617666067, zjun2323@sina.cn
- Not yet recruiting
Fuyang Cancer Hospital
Fuyang, Anhui, 23600
Hesheng Qian, Bachelor, 13956814015, qianhesheng@soho.com
- Not yet recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Rongbo Lin, Bachelor, 13705919382, rongbo_lin@163.com
- Not yet recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Ruihua Xu, Doctor, 86-20-87343468, ruihxu@163.com
- Not yet recruiting
Nanfang Hospital
Guangzhou, Guangdong, 510515
Min Shi, Doctor, 13826259986, nfyyzlksm@163.com
- Not yet recruiting
The Second Affiliated Hospital of Guilin Medical College
Guilin, Guangxi, 541004
Bihui Li, Master, 18378316283, lbihui0202@163.com
- Not yet recruiting
The first affiliated hospital of hainan medical university
Haikou, Hainan, 570102
Jinsheng Wu, Master, 13707599070, wjs7911@126.com
- Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Zhiwei Li, Doctor, 15004683651, lzhw0451@163.com
- Not yet recruiting
Jiangmen Central Hospital
Jiangmen, Guangdong, 529000
Gengsheng Yu, Doctor, 13828077428, gengsheng_yu@hotmail.com
- Not yet recruiting
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, 264000
Bo Liu, Master, 15553115688, lb20201110@163.com
- Not yet recruiting
Gansu Prouincial Cancer Hospital
Lanzhou, Gansu, 730000
Yuhua/ Liu, Bachelor, 15682892029, tianlujyx@163.com
Zhihu Li, Master, 18993042850, zhihu_li666@163.com
- Not yet recruiting
Lu'an People's Hospital
Lu'an, Anhui, 237000
Feng Rong, Master, 13635649383, wazhl1996@163.com
- Not yet recruiting
The 1st Affiliated Hospital of He'nan University of Science and Technology
Luoyang, Henan, 471000
Jun Yao, Doctor, 13663790098, 13663790098@163.com
- Recruiting
Maanshan People's Hospital
Maanshan, Anhui, 243000
Dequan Ding, Bachelor, 18055569797, 35559686@qq.com
- Not yet recruiting
Meizhou People's Hospital
Meizhou, Guangdong, 514031
Xiaoyang Wang, Bachelor, 13543209534, 1002192141@qq.com
- Not yet recruiting
Nanchong Central Hospital
Nanchong, Sichuan, 637000
Yonghong Sun, Bachelor, 13890718829, 372821574@qq.com
- Not yet recruiting
NanJing Drum Tower Hospital
Nanjing, Jiangsu, 210000
Jia Wei, Doctor, 13951785234, jiawei99@nju.edu.cn
- Not yet recruiting
Jiangning Hospital of Nanjing City
Nanjing, Jiangsu, 211100
JinLi Ding, Master, 15895913452, djlcl0301@126.com
- Not yet recruiting
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530021
Yongqiang Li, Master, 13457161928, lyq702702@126.com
- Not yet recruiting
Puyang Oilfield General Hospital
Puyang, Henan, 457001
Wenbin Yue, Doctor, 13839276125, yuewenbin2013@163.com
- Not yet recruiting
Fudan university shanghai cancer center
Shanghai, Shanghai Municipality, 200032
Zhe Zhang, Doctor, 18121299381, zhangzhe2010fduscc@gmail.com
- Not yet recruiting
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200120
Xiuying Xiao, Doctor, 13564579313, xiaoxiuying2002@163.com
- Not yet recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050010
Qun Zhao, Doctor, 13930162111, zhaoqun516@126.com
- Not yet recruiting
Shanxi Cancer hospital
Taiyuan, Shanxi, 030000
Wenhui Yang, Doctor, 15835133400, yangwenhui10012@163.com
- Not yet recruiting
Tangshan People's Hospital
Tangshan, Hebei, 063001
Zhiwu Wang, Doctor, 18931506162, tcm2000@163.com
- Not yet recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300202
Hongli Li, Doctor, 022-23340123-3252, hongli@126.com
- Not yet recruiting
Xinjiang Medical University Affiliated Cancer Hospital
Ürümqi, Xinjiang, 810000
YanLi Qu, Master, 18160627936, quyanli73@163.com
- Not yet recruiting
Wenzhou Medical University Affiliated First Hospital
Wenzhou, Zhejiang, 325000
Shuqin Jin, Bachelor, 139 5778 9842, zjwzjsq@163.com
- Not yet recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430023
Hongli Liu, Doctor, 13995680822, hongli_liu@hust.edu.cn
- Not yet recruiting
Gansu Wuwei Tumour Hospital
Wuwei, Gansu, 733099
Linzhi Lu, Bachelor, 13659359016, lulinzh12006@163.com
- Not yet recruiting
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an, Shanxi, 710000
Aili Suo, Doctor, 18991232561, ailisuo@mail.xjtu.edu.cn
- Not yet recruiting
Xiangyang Central Hospital
Xiangyang, Hubei, 441000
Wei Gong, Doctor, 13597483320, 44828977@qq.com
- Not yet recruiting
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225009
Xianwen Zhang, Doctor, 18051060926, zhangxwok@163.com
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Yanru Qin, Doctor, 13676932999, yanruqin@163.com
About this study
Official title: 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
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
- Being tested
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB2102 for injection (7.5 mg) +Benmelstobart+ChemotherapyDrug
TQB2102 for injection is an antibody-coupled drug Benmelstobart is a Programmed cell death -Ligand 1 (PD-L1) Antibody
TQB2102 for injection (6 mg/7.5 mg) +Benmelstobart+ChemotherapyDrug
TQB2102 for injection is an antibody-coupled drug Benmelstobart is a PD-L1 Antibody
TQB2102 for injection (6 mg/7.5 mg) +Penpulimab+ChemotherapyDrug
TQB2102 for injection is an antibody-coupled drug
| Study group | Role | What they receive |
|---|---|---|
| TQB2102 for injection (7.5 mg) +Benmelstobart+Chemotherapy | Experimental | TQB2102 for Injection and bemarituzumab are administered intravenously every three weeks, while chemotherapy is given orally from Day 1 to Day 15, with each treatment cycle lasting 21 days.
TQB2102 and bemosubicinumab for injection every three weeks and capecitabine Day1-Day15 administered orally in 21-day cycles Receives: Drug: TQB2102 for injection (7.5 mg) +Benmelstobart+Chemotherapy |
| TQB2102 for injection (6 mg/7.5 mg) +Benmelstobart+Chemotherapy | Experimental | TQB2102 for Injection and bemarituzumab are administered intravenously every three weeks, while chemotherapy is given orally from Day 1 to Day 15, with each treatment cycle lasting 21 days. Receives: Drug: TQB2102 for injection (6 mg/7.5 mg) +Benmelstobart+Chemotherapy |
| TQB2102 for injection (6 mg/7.5 mg) +Penpulimab+Chemotherapy | Experimental | TQB2102 for Injection and Penpulimab are administered intravenously every three weeks, while chemotherapy is given orally from Day 1 to Day 15, with each treatment cycle lasting 21 days. Receives: Drug: TQB2102 for injection (6 mg/7.5 mg) +Penpulimab+Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Defined as the percentage of Complete Response (CR) plus partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria and guidelines for response criteria for use in trials testing immunotherapeutics (iRECIST )for solid tumors.
Measured: Through study completion, an average of 1 year
Secondary outcomes (4)
Progression-free survival (PFS)
Defined as the time from first use of TQB2102 to first disease progression or death from any cause
Measured: Baseline up to disease progression or die, an average of 3 year
Duration of Response (DOR)
Defined as the time from first documented response to documented disease progression or death
Measured: Through study completion, an average of 1 year
Overall survival(OS)
Overall survival refers to the time from the first treatment to death from any cause
Measured: Baseline up to die, an average of 3 year
Number of patients with adverse events (AEs) and serious adverse events (SAEs)
Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: Baseline up to 28 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start21 Nov 2024
- Primary completionSep 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06767800
- Sponsor's protocol ID
- TQB2102-II-04
- Status last verified
- Aug 2024
- First submitted
- 6 Jan 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06767800
- Acronym / sponsor ID
- TQB2102-II-04
- Conditions
- Gastroesophageal Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Nov 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TQB2102 for injection (7.5 mg) +Benmelstobart+Chemotherapy | Experimental | Drug: TQB2102 for injection (7.5 mg) +Benmelstobart+ChemotherapyTQB2102 for Injection and bemarituzumab are administered intravenously every three weeks, while chemotherapy is given orally from Day 1 to Day 15, with each treatment cycle lasting 21 days. TQB2102 and bemosubicinumab for injection every three weeks and capecitabine Day1-Day15 administered orally in 21-day cycles |
| TQB2102 for injection (6 mg/7.5 mg) +Benmelstobart+Chemotherapy | Experimental | Drug: TQB2102 for injection (6 mg/7.5 mg) +Benmelstobart+ChemotherapyTQB2102 for Injection and bemarituzumab are administered intravenously every three weeks, while chemotherapy is given orally from Day 1 to Day 15, with each treatment cycle lasting 21 days. |
| TQB2102 for injection (6 mg/7.5 mg) +Penpulimab+Chemotherapy | Experimental | Drug: TQB2102 for injection (6 mg/7.5 mg) +Penpulimab+ChemotherapyTQB2102 for Injection and Penpulimab are administered intravenously every three weeks, while chemotherapy is given orally from Day 1 to Day 15, with each treatment cycle lasting 21 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
- Patients who have not received prior systemic therapy for locally advanced or metastatic gastric cancer and who have experienced tumor recurrence or metastasis at least 6 months after the completion of prior adjuvant or neoadjuvant therapy may be enrolled;
Key exclusion criteria (16 listed)
- 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;
- Arterial/venous thrombotic events, such as cerebrovascular accidents, deep vein thrombosis, and pulmonary embolism, have occurred within 6 months prior to the first dose;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQB2102 for injection (7.5 mg) +Benmelstobart+ChemotherapyTQB2102 for injection is an antibody-coupled drug Benmelstobart is a Programmed cell death -Ligand 1 (PD-L1) Antibody | Drug | TQB2102 for injection (7.5 mg) +Benmelstobart+Chemotherapy |
| TQB2102 for injection (6 mg/7.5 mg) +Benmelstobart+ChemotherapyTQB2102 for injection is an antibody-coupled drug Benmelstobart is a PD-L1 Antibody | Drug | TQB2102 for injection (6 mg/7.5 mg) +Benmelstobart+Chemotherapy |
| TQB2102 for injection (6 mg/7.5 mg) +Penpulimab+ChemotherapyTQB2102 for injection is an antibody-coupled drug | Drug | TQB2102 for injection (6 mg/7.5 mg) +Penpulimab+Chemotherapy |
Primary outcome
Objective Response Rate (ORR)
Time frame: Through study completion, an average of 1 year
Defined as the percentage of Complete Response (CR) plus partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria and guidelines for response criteria for use in trials testing immunotherapeutics (iRECIST )for solid tumors.
4 secondary outcomes
Progression-free survival (PFS)
Time frame: Baseline up to disease progression or die, an average of 3 year
Duration of Response (DOR)
Time frame: Through study completion, an average of 1 year
Overall survival(OS)
Time frame: Baseline up to die, an average of 3 year
Number of patients with adverse events (AEs) and serious adverse events (SAEs)
Time frame: Baseline up to 28 days after the last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TQB2102 for injection (7.5 mg) +Benmelstobart+Chemotherapy, TQB2102 for injection (6 mg/7.5 mg) +Benmelstobart+Chemotherapy and TQB2102 for injection (6 mg/7.5 mg) +Penpulimab+Chemotherapy in people with Gastroesophageal Adenocarcinoma, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 39 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruihua Xu, Doctor (86-20-87343468, ruihxu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025; AzTrials last refreshed its copy on 6 Nov 2026.