The Clinical Trial of TQB2102 for Injection Against Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer
Launched by CHIA TAI TIANQING PHARMACEUTICAL GROUP NANJING SHUNXIN PHARMACEUTICAL CO., LTD. · Jun 6, 2024
Trial Information
Current as of July 23, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating a new treatment called TQB2102 for people with a specific type of breast cancer known as HER2 negative recurrent or metastatic breast cancer. This means the cancer has returned or spread and does not have a certain protein, HER2, that is often targeted in other treatments. The study aims to find out how effective TQB2102 is in treating this condition and to ensure it is safe for patients.
To participate in the trial, individuals must be between 18 and 75 years old and have had previous treatments for their cancer that did not work. Participants should also have measurable cancer that cannot be treated with surgery or radiation. It's important for potential participants to be in good overall health and to meet certain medical criteria. Throughout the study, participants will receive the new treatment and be monitored closely for any side effects and how well the treatment is working. If you or someone you know might be interested in this trial, it's a good idea to talk to a doctor to see if it’s a suitable option.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • The participants voluntarily participate in the study and sign an informed consent form.
- • Age: 18-75 years old; Eastern Cooperative Oncology Group (ECOG) score: ≤1 point; Expected survival period exceeds 3 months.
- • Breast cancer patients diagnosed as HER2 negative by pathology, with evidence of local recurrence or distant metastasis are not suitable for surgery or radiation therapy aimed at healing.
- • Sufficient tumor tissue samples must be available for HER2 evaluation by pathologists at the main research center.
- • The participants's previous treatment needs to meet the following criteria: failure after receiving at least first-line systemic chemotherapy during the recurrence /metastasis stage (for hormone receptor positive participants, failure after receiving cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors combined with endocrine therapy during the recurrence/metastasis stage.
- • There exists disease progression or intolerance during or after the most recent treatment before enrollment.
- • According to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 standard, there should be at least one measurable lesion.
- • The main organ functions well and meets certain standards.
- • Female participants of childbearing age should agree to use contraceptive measures during the study period and within 6 months after the end of the study; within 7 days prior to enrollment, the serum pregnancy test was negative and must be a non lactating subject; male participants should agree to adopt avoidance measures during the study period and within 6 months after the end of the study period.
- Exclusion Criteria:
- * Concomitant diseases and medical history:
- • 1. Have experienced or currently suffer from other malignant tumors within 5 years prior to the first medication use;
- • 2. Uncontrollable toxic reactions above CTCAE level 1 caused by any previous treatment;
- • 3. Received significant surgical treatment or significant traumatic injury within 28 days prior to the first medication use;
- • 4. Long term unhealed wounds or fractures;
- • 5. Participants who have a history of interstitial lung disease/pneumonia (non infectious) requiring steroid intervention treatment in the past, or currently have interstitial lung disease/pneumonia, or whose screening imaging suggests suspected interstitial lung disease/pneumonia and cannot be ruled out;
- • 6. An arterial/venous thrombotic event occurred within 6 months prior to the first medication use;
- • 7. Individuals with a history of psychiatric drug abuse who are unable to quit or have mental disorders;
- • 8. Subjects with any severe and/or uncontrolled diseases. Rheumatoid arthritis with joint function activity graded as Grade IV or requiring wheelchair or bed rest.
- * Tumor related symptoms and treatment:
- • 1. Participants who have received other anti-tumor drug treatments such as chemotherapy, curative radiotherapy, or immunotherapy within 4 weeks before the first medication, or who are still within the 5 half-lives of the drug (whichever is the shortest); Participants who have previously received local radiotherapy;
- • 2. Received endocrine therapy or traditional Chinese patent medicines and simple preparations with anti-tumor indications specified in the National Medical Products Administration (NMPA) approved drug directions within 2 weeks before the first drug use;
- • 3. Imaging shows that the tumor has invaded important blood vessels, or the researcher determines that the tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during subsequent studies;
- • 4. Uncontrollable pleural effusion, ascites, and moderate or higher amounts of pericardial effusion that require repeated drainage;
- • 5. Known presence of cancerous meningitis or clinically active central nervous system metastasis;
- • 6. Severe bone damage caused by tumor bone metastasis. Suffering from lung diseases that have been determined by the researcher to be unsuitable for participation in this study.
- • Individuals who are known to be allergic to the investigational drug or its excipients, or allergic to humanized monoclonal antibody products.
- • Individuals who have participated in and used other anti-tumor clinical trial drugs within 4 weeks prior to the first medication use.
- • According to the judgment of the researchers, there are situations that seriously endanger the safety of the subjects or affect their completion of the study.
About Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. is a prominent pharmaceutical company based in China, specializing in the research, development, manufacturing, and commercialization of innovative therapeutic solutions. With a strong commitment to advancing healthcare, the company focuses on a diverse range of therapeutic areas, including oncology, infectious diseases, and cardiovascular health. Leveraging cutting-edge technology and a robust R&D pipeline, Chia Tai Tianqing aims to enhance patient outcomes through high-quality pharmaceuticals and clinical trials that adhere to international standards. The company is dedicated to fostering collaborations and partnerships to drive medical innovation and improve global health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Harbin, Heilongjiang, China
Harbin, Heilongjiang, China
Hangzhou, Zhejiang, China
Wuhan, Hubei, China
Xi'an, Shanxi, China
Harbin, , China
Harbin, , China
Changde, Hunan, China
Zhengzhou, Henan, China
Ma'anshan, Anhui, China
Bozhou, Anhui, China
Chuzhou, Anhui, China
Hefei, Anhui, China
Wuhu, Anhui, China
Shanghai, Shanghai, China
Suzhou, Zhejiang, China
Wenzhou, Zhejiang, China
ürümqi, Xinjiang, China
Zhengzhou, Henan, China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported