RecruitingPhase 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

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


Sponsor

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

Enrollment

204 participants

Start Date

Nov 21, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria8

  • 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.

Exclusion Criteria16

  • 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;
  • 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.

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Interventions

DRUGTQB2102 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

DRUGTQB2102 for injection (6 mg/7.5 mg) +Benmelstobart+Chemotherapy

TQB2102 for injection is an antibody-coupled drug Benmelstobart is a PD-L1 Antibody

DRUGTQB2102 for injection (6 mg/7.5 mg) +Penpulimab+Chemotherapy

TQB2102 for injection is an antibody-coupled drug


Locations(39)

Fuyang Cancer Hospital

Fuyang, Anhui, China

Lu'an People's Hospital

Lu'an, Anhui, China

Maanshan People's Hospital

Maanshan, Anhui, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

The first affiliated hospital of chongqing medical university

Chongqing, Chongqing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Gansu Prouincial Cancer Hospital

Lanzhou, Gansu, China

Gansu Wuwei Tumour Hospital

Wuwei, Gansu, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Nanfang Hospital

Guangzhou, Guangdong, China

Jiangmen Central Hospital

Jiangmen, Guangdong, China

Meizhou People's Hospital

Meizhou, Guangdong, China

The Second Affiliated Hospital of Guilin Medical College

Guilin, Guangxi, China

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

The first affiliated hospital of hainan medical university

Haikou, Hainan, China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Tangshan People's Hospital

Tangshan, Hebei, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Anyang Cancer Hospital

Anyang, Henan, China

The 1st Affiliated Hospital of He'nan University of Science and Technology

Luoyang, Henan, China

Puyang Oilfield General Hospital

Puyang, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Xiangyang Central Hospital

Xiangyang, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

The Second Xiangya Hospital Of Central South University

Changsha, Hunan, China

NanJing Drum Tower Hospital

Nanjing, Jiangsu, China

Jiangning Hospital of Nanjing City

Nanjing, Jiangsu, China

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, China

Jilin Cancer Hospital

Changchun, Jilin, China

Cancer Hospital of Shandong First Medical University

Jinan, Shandong, China

Fudan university shanghai cancer center

Shanghai, Shanghai Municipality, China

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Shanxi Cancer hospital

Taiyuan, Shanxi, China

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi’an, Shanxi, China

Nanchong Central Hospital

Nanchong, Sichuan, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

Xinjiang Medical University Affiliated Cancer Hospital

Ürümqi, Xinjiang, China

Wenzhou Medical University Affiliated First Hospital

Wenzhou, Zhejiang, China

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NCT06767800


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