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

Launched by CHIA TAI TIANQING PHARMACEUTICAL GROUP NANJING SHUNXIN PHARMACEUTICAL CO., LTD. · Jan 6, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called TQB2102, which is being tested for patients with a specific type of cancer known as HER2-positive gastroesophageal adenocarcinoma. This type of cancer is difficult to treat because it cannot be removed through surgery and may have spread to other parts of the body. TQB2102 is designed to target cancer cells more effectively by binding to unique parts of a protein called HER2 on the surface of these cells. The study will see how well TQB2102 works when given together with other treatments, including some new injections and possibly chemotherapy.

To be eligible for this trial, participants need to be between 18 and 75 years old and have a certain level of HER2-positive cancer that hasn't been treated with other systemic therapies recently. They should also be in good general health and able to undergo the necessary tests to confirm their cancer status. Participants can expect to receive a combination of treatments and will be closely monitored for any side effects or changes in their condition. It's important to know that this trial is not yet recruiting participants, so it may take some time before it is open for enrollment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.