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

A Phase Ib/II Clinical Study to Evaluate the Efficacy and Safety of TQB2930 Injection and Chemotherapy With or Without Bevacizumab in Subjects With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Unresectable Locally Advanced or Metastatic Colorectal Cancer

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: TQB2930 injection + Oxaliplatin injection + Capecitabine tablets + Bevacizumab injection; Drug: TQB2930 injection + Oxaliplatin injection + Capecitabine tablets

• Study Type: Interventional
• Enrollment (Estimated): 71
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Ruihua Xu, Doctor; Phone Number: 020-87343468; Email: xurh@syscc.org.cn

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100034
      • Peking University First Hospital
      • Contact: Shikai Wu, Doctor; Phone Number: 15810037307; Email: Skywu4923@sina.com
  • Gansu
    • Lanzhou, Gansu, China, 730050
      • Gansu Provincial Tumor Hospital
      • Contact: Zhihu Li, Master; Phone Number: 18993042850; Email: 245698692@qq.com
  • Guangxi
    • Nanning, Guangxi, China, 530000
      • Guangxi Zhuang Autonomous Region Cancer Hospital
      • Contact: Rong Liang, Doctor; Phone Number: 18677070811; Email: 53371159@qq.com
  • Guizhou
    • Zunyi, Guizhou, China, 563000
      • The Affiliated Hospital of Zunyi Medical University
      • Contact: Jiwei Wang, Doctor; Phone Number: 18013964231; Email: zmu_wangjw@163.com
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150000
      • Harbin Medical University Cancer Hospital
      • Contact: Tongsen Zheng, Doctor; Phone Number: 15134569619; Email: zhengtongsen@126.com
      • Contact: Yuxian Bai, Doctor; Phone Number: 13945095085; Email: bai_yuxian@126.com
  • Henan
    • Zhengzhou, Henan, China, 450000
      • The First Affiliated Hospital of Zhengzhou University
      • Contact: Yongxu Jia, Doctor; Phone Number: 15237128281; Email: fccjiayx@zzu.edu.cn
    • Zhengzhou, Henan, China, 450000
      • Henan Cancer Hospital
      • Contact: Ying Liu, Doctor; Phone Number: 13783604602; Email: yaya7207@126.com
    • Zhengzhou, Henan, China, 450000
      • The Third People's Hospital of Zhengzhou
      • Contact: HaiCun Wang, Master; Phone Number: 13803833783; Email: whc1975@126.com
  • Hubei
    • Jingzhou, Hubei, China, 434099
      • Jingzhou First People's Hospital
      • Contact: Yan Hu, Master; Phone Number: 18163137369; Email: helensparkle@163.com
    • Wuhan, Hubei, China, 430022
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Hongli Liu, Doctor; Phone Number: 13995680822; Email: hongliliu@hust.edu.cn
  • Hunan
    • Changsha, Hunan, China, 410013
      • Hunan Cancer Hospital
      • Contact: Yi He, Doctor; Phone Number: 18692237222; Email: heyi@hnca.org.cn
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Zhongda Hospital Southeast University
      • Contact: CaiLian Wang, Doctor; Phone Number: 13851756378; Email: wangcailian65@hotmail.com
    • Nanjing, Jiangsu, China, 210000
      • Jiangsu Provincial Cancer Hospital
      • Contact: Yuanhua Liu, Doctor; Phone Number: 13305180356; Email: yuanhualiu02@hotmail.com
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University
      • Contact: Tingting Liang, Doctor; Phone Number: 15804303776; Email: liangting2006@163.com
    • Changchun, Jilin, China, 130021
      • Jilin Cancer Hospital
      • Contact: Hongxia Cui, Master; Phone Number: 13504436090; Email: 2503074283@qq.com
  • Liaoning
    • Shenyang, Liaoning, China, 110000
      • Liaoning Cancer Hospital & Institute
      • Contact: Jingdong Zhang, Doctor; Phone Number: 18040007878; Email: 13804027878@163.com
  • Shaanxi
    • Xi'an, Shaanxi, China, 710000
      • The First Affiliated Hospital of Xi'an Jiaotong University Medical College
      • Contact: Aili Suo, Doctor; Phone Number: 18991232561; Email: Ailisuo@mail.xjtu.edu.cn
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200127
      • Renji Hospital, Shanghai Jiao Tong University School of Medicine
      • Contact: XiuYing Xiao, Doctor; Phone Number: 13564579313; Email: xiaoxiuying2002@163.com
  • Shanxi
    • Xi’an, Shanxi, China, 710000
      • The Second Affiliated Hospital of Air Force Medical University
      • Contact: Haichuan Su, Doctor; Phone Number: 18629190366; Email: cntdgcp@163.com
    • Xi’an, Shanxi, China, 710000
      • The First Affiliated Hospital of Air Force Medical University
      • Contact: Yongzhan Nie, Doctor; Phone Number: 15091520001; Email: nieyongzhan@qq.com
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300121
      • Tianjin Union Medical Center
      • Contact: Mingqing Zhang, Doctor; Phone Number: 15122875158; Email: zmq1003@163.com
    • Tianjin, Tianjin Municipality, China, 300202
      • Tianjin Medical University Cancer Institute & Hospital
      • Contact: Zhanyu Pan, Master; Phone Number: 18622221256; Email: tjpanzy@126.com
  • Xinjiang
    • Ürümqi, Xinjiang, China, 830054
      • Xinjiang Medical University Affiliated Tumor Hospital
      • Contact: YanLi Qu, Master; Phone Number: 18160627963; Email: quyanli73@163.com
  • Zhejiang
    • Lishui, Zhejiang, China, 323000
      • Lishui Municipal Central Hospital
      • Contact: Yanru Xie, Master; Phone Number: 13567615770; Email: 43437677@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TQB2930 injection + Oxaliplatin injection + Capecitabine tablets + Bevacizumab injection	Drug: TQB2930 injection + Oxaliplatin injection + Capecitabine tablets + Bevacizumab injection; TQB2930 enhances the binding to HER2 protein on the surface of tumor cells and increases HER2 internalization by simultaneously targeting ECD2 and ECD4, two non-overlapping epitopes of HER2 protein, which in turn more effectively down-regulates HER2 protein on the surface of tumor cells and dually blocks HER2 signaling. Oxaliplatin can block DNA replication and transcription and induce tumor cell apoptosis. Capecitabine inhibits thymidylate synthase (TS) and interferes with DNA synthesis. Bevacizumab blocks Vascular Endothelial Growth Factor (VEGF) binding to receptors and inhibits tumor angiogenesis.
Active Comparator: TQB2930 injection + Oxaliplatin injection + Capecitabine tablets	Drug: TQB2930 injection + Oxaliplatin injection + Capecitabine tablets; TQB2930 enhances the binding to HER2 protein on the surface of tumor cells and increases HER2 internalization by simultaneously targeting Extracellular Domain 2 (ECD2) and Extracellular Domain 4 (ECD4), two non-overlapping epitopes of HER2 protein, which in turn more effectively down-regulates HER2 protein on the surface of tumor cells and dually blocks HER2 signaling. Oxaliplatin can block DNA replication and transcription and induce tumor cell apoptosis. Capecitabine inhibits thymidylate synthase (TS) and interferes with DNA synthesis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recommended Phase 2 Dose	It refers to the safe and effective dose range that can be used for phase II study determined through phase I clinical trial.	Baseline up to 21 days
Adverse event (AE)	Incidence and severity of adverse events.	From the subject's signing of the informed consent form to 28 days after the last dose or the start of new anti-tumor therapy (whichever occurs first)
Objective Response Rate	The proportion of patients achieving complete response and partial response among the total evaluable cases.	Baseline up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Half-life	The time it takes for the concentration of a drug in the body (usually the plasma concentration) to decrease to half of its initial value.	Baseline up to 24 months
Plasma concentration-time profiles	Total area covered under the curve plotted with time as X-axis and plasma concentration as Y-axis.	Baseline up to 24 months
Apparent clearance	The rate at which the drug is cleared from the body.	Baseline up to 24 months
Apparent terminal volume of distribution	Describe the drug distribution in the body.	Baseline up to 24 months
Trough plasma concentration	Minimum plasma drug concentration level at the end of the dosing interval (before the next dosing).	Baseline up to 24 months
Disease Control Rate	The percentage of subjects with a complete response, partial response, or stable disease as determined by RECIST 1.1.	Baseline up to 24 months
Duration Of Response	The time from the first assessment of the tumor as a complete response or partial response to the first occurrence of disease progression or death from any cause.	Baseline up to 24 months
Progression Free Survival	Progression Free Survival (PFS) is defined as the length of time from the start of treatment until the disease progresses or the patient dies from any cause.	Baseline up to 24 months
Overall Survival	The time from the start of initial treatment to death from any cause.	Baseline up to 24 months
Anti-Drug Antibodies (ADA) incidence	Proportion of anti-drug antibody produced in the population of patients using the drug.	Baseline up to 24 months

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: June 12, 2026
• First Submitted That Met QC Criteria: June 12, 2026
• First Posted (Actual): June 17, 2026

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Coordination Complexes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Nucleosides; Uracil; Pyrimidinones; Deoxyribonucleosides; Fluorouracil; Capecitabine; Oxaliplatin; Bevacizumab
• Other Study ID Numbers: TQB2930-Ib/II-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No