A Clinical Study of TQB2930 Injection and Chemotherapy With or Without Bevacizumab in the Treatment of Advanced Colorectal Cancer

Starting soon · Phase 1/Phase 2

Conditions studied: Colorectal Cancer

In brief

To assess the safety and preliminary efficacy of TQB2930 and chemotherapy with or without bevacizumab in subjects with HER2-positive unresectable locally advanced or metastatic colorectal cancer (CRC).

Key facts

Study ID

NCT07653685

Run by

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

People needed

71

Starts

2026-07-01

Expected to finish

2028-12-01

Last updated by the study team

2026-06-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects voluntarily participate in this study, sign the informed consent form, and have good compliance
• Age: 18-75 years (including the boundary when signing the informed consent form)
• Eastern Cooperative Oncology Group (ECOG) score: 0-1
• Expected survival of more than 3 months
• Unresectable locally advanced or metastatic colorectal cancer diagnosed by histopathology/cytology
• HER2 positive tested
• Presence of at least one measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
• Subjects should agree to use contraception during the study and for 6 months after the end

You may not qualify if…

• Patients with previously confirmed Microsatellite Instability Microsatellite Instability-High Deficient Mismatch Repair (MSI-H/dMMR)
• Presence of conditions affecting intravenous, venous blood sampling, or multiple factors affecting oral medications
• Active inflammatory bowel disease within 28 days prior to first dose
• Other malignancies within 5 years prior to the first dose or currently suffering from other malignancies
• Unresolved toxicity greater than CTCAE Grade 1 due to any prior therapy
• Major surgical treatment, significant traumatic injury within 28 days prior to the first dose or anticipation of major surgery during study treatment
• Had wounds or fractures that had not been healed for a long time
• Cerebrovascular accident, deep venous thrombosis and pulmonary embolism within 6 months prior to the first dose
• Patients with a history of psychotropic substance abuse who cannot quit or have mental disorders
• Subjects with any severe and/or uncontrolled disease
• Known tumor-related carcinomatous meningitis with symptoms of brain metastases or symptom control for less than 4 weeks
• Patients with imaging suggestive of tumor invasion of major blood vessels or fatal massive hemorrhage due to tumor rupture or invasion of major blood vessels judged by the investigator to be very likely to occur during the study
• Failure to control serous effusions requiring repeated drainage
• Local radiotherapy or 4. Bone marrow irradiation > 30% for bone metastasis before the first medication
• Known tumor-related spinal cord compression, weight-bearing bone pathological fracture, extensive bone metastasis, or uncontrollable tumor bone metastasis-related pain
• Patients who have received chemotherapy, targeted therapy, immunotherapy or other systemic anti-tumor drug therapy before the first medication;
• Received Chinese patent medicine treatment with anti-tumor indications in the package insert of National Medical Products Administration (NMPA) approved drugs before study treatment
• History of live attenuated vaccination before the first dose or planned live attenuated vaccination during the study;
• Previous history of severe allergy of unknown origin
• According to the investigator's judgment, there are concomitant diseases that seriously endanger the subject's safety or affect the completion of the study, or the subject is considered unsuitable for other reasons

Where it is running

• Peking University First Hospital — Beijing, Beijing Municipality, China
• Gansu Provincial Tumor Hospital — Lanzhou, Gansu, China
• Guangxi Zhuang Autonomous Region Cancer Hospital — Nanning, Guangxi, China
• The Affiliated Hospital of Zunyi Medical University — Zunyi, Guizhou, China
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China
• Henan Cancer Hospital — Zhengzhou, Henan, China
• The first affiliated hospital of Zhengzhou university — Zhengzhou, Henan, China
• The Third People's Hospital of Zhengzhou — Zhengzhou, Henan, China
• Jingzhou First People's Hospital — Jingzhou, Hubei, China
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China
• Hunan Cancer Hospital — Changsha, Hunan, China
• Jiangsu Provincial Cancer Hospital — Nanjing, Jiangsu, China
• Zhongda Hospital Southeast University — Nanjing, Jiangsu, China
• Jilin Cancer Hospital — Changchun, Jilin, China
• The first hospital of Jilin University — Changchun, Jilin, China
• Liaoning Cancer Hospital & Institute — Shenyang, Liaoning, China
• The First Affiliated Hospital of Xi'an Jiaotong University Medical College — Xi'an, Shaanxi, China
• Renji Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China
• The First Affiliated Hospital of Air Force Medical University — Xi’an, Shanxi, China
• The Second Affiliated Hospital of Air Force Medical University — Xi’an, Shanxi, China
• Tianjin Union Medical Center — Tianjin, Tianjin Municipality, China
• Tianjin Medical University Cancer Institute & Hospital — Tianjin, Tianjin Municipality, China
• Xinjiang Medical University Affiliated Tumor Hospital — Ürümqi, Xinjiang, China
• Lishui Municipal Central Hospital — Lishui, Zhejiang, China

Full record on ClinicalTrials.gov

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