A Clinical Trial Evaluating TQB2930 Injection and Chemotherapy With or Without Bevacizumab in Patients With HER2-Abnormally Expressed Unresectable Locally Advanced or Metastatic Colorectal Cancer.
A Phase Ib/II Clinical Study to Evaluate the Efficacy and Safety of TQB2930 Injection and Chemotherapy With or Without Bevacizumab in Participants With HER2-Abnormally Expressed Unresectable Locally Advanced or Metastatic Colorectal Cancer.
1 other identifier
interventional
71
1 country
31
Brief Summary
To assess the safety and preliminary efficacy of TQB2930 and chemotherapy with or without bevacizumab in sparticipants with HER2-Abnormally Expressed locally advanced or metastatic colorectal cancer (CRC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 colorectal-cancer
Started Sep 2026
Shorter than P25 for phase_1 colorectal-cancer
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2026
CompletedFirst Posted
Study publicly available on registry
June 17, 2026
CompletedStudy Start
First participant enrolled
September 3, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
September 22, 2026
September 1, 2026
9 months
June 12, 2026
September 17, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
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 participants 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 participants achieving complete response and partial response among the total evaluable cases.
Baseline up to 24 months
Secondary Outcomes (10)
Half-life
Baseline up to 24 months
Plasma concentration-time profiles
Baseline up to 24 months
Apparent clearance
Baseline up to 24 months
Apparent terminal volume of distribution
Baseline up to 24 months
Trough plasma concentration
Baseline up to 24 months
- +5 more secondary outcomes
Study Arms (2)
TQB2930 injection +chemotherapy + Bevacizumab injection
EXPERIMENTALTQB2930 injection +chemotherapy
ACTIVE COMPARATORInterventions
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. Irinotecan hydrochloride injection inhibits topoisomerase-I via its active metabolite SN-38, prevents religation of DNA single-strand breaks, causes irreversible DNA double-strand damage and induces tumor cell apoptosis. Capecitabine inhibits thymidylate synthase (TS) and interferes with DNA synthesis. Bevacizumab blocks VEGF binding to receptors and inhibits tumor angiogenesis.
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. Irinotecan hydrochloride injection inhibits topoisomerase-I via its active metabolite SN-38, prevents religation of DNA single-strand breaks, causes irreversible DNA double-strand damage and induces tumor cell apoptosis. Capecitabine inhibits thymidylate synthase (TS) and interferes with DNA synthesis.
Eligibility Criteria
You may qualify if:
- Participants 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-Abnormally Expressed tested
- Presence of at least one measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
- Participants should agree to use contraception during the study and for 6 months after the end
You may not qualify if:
- Participants 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
- Participants 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016, China
Gansu Provincial Tumor Hospital
Lanzhou, Gansu, 730050, China
The First People's Hospital of Foshan
Foshan, Guangdong, 528000, China
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510000, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Guangxi Zhuang Autonomous Region Cancer Hospital
Nanning, Guangxi, 530000, China
The Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563000, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000, China
Qiqihar First Hospital
Qiqihar, Heilongjiang, 161005, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
The first affiliated hospital of Zhengzhou university
Zhengzhou, Henan, 450000, China
The Third People's Hospital of Zhengzhou
Zhengzhou, Henan, 450000, China
Jingzhou First People's Hospital
Jingzhou, Hubei, 434099, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
Jiangsu Provincial Cancer Hospital
Nanjing, Jiangsu, 210000, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009, China
Jiangxi Provincal People's Hospital
Nanchang, Jiangxi, 330000, China
Jilin Cancer Hospital
Changchun, Jilin, 130021, China
The first hospital of Jilin University
Changchun, Jilin, 130021, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110000, China
The First Affiliated Hospital of Xi'an Jiaotong University Medical College
Xi'an, Shaanxi, 710000, China
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127, China
The First Affiliated Hospital of Air Force Medical University
Xi’an, Shanxi, 710000, China
The Second Affiliated Hospital of Air Force Medical University
Xi’an, Shanxi, 710000, China
Tianjin Union Medical Center
Tianjin, Tianjin Municipality, 300121, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300202, China
Xinjiang Medical University Affiliated Tumor Hospital
Ürümqi, Xinjiang, 830054, China
Lishui Municipal Central Hospital
Lishui, Zhejiang, 323000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2026
First Posted
June 17, 2026
Study Start
September 3, 2026
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
December 1, 2028
Last Updated
September 22, 2026
Record last verified: 2026-09