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ClinicalTrials.gov ID

NCT07653685

Lead Sponsor

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

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 1Phase 2

Enrollment

71Estimated

Last Update Posted

Jun 17, 2026Actual

Start Date

Jul 2026Estimated

Primary Completion Date

Jun 2027Estimated

Completion Date

Dec 2028Estimated

Official Title

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

Brief Summary

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).

• Colorectal Cancer

• TQB2930 injection + Oxaliplatin injection + Capecitabine tablets + Bevacizumab injection
• TQB2930 injection + Oxaliplatin injection + Capecitabine tablets

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

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

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