NCT07653685 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.
| NCT ID | NCT07653685 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 71 participants |
| Start Date | 2026-09-03 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 71 participants in total. It began in 2026-09-03 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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 participants' safety or affect the completion of the study, or the participant is considered unsuitable for other reasons
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07653685 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07653685 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07653685 currently recruiting?
Yes, NCT07653685 is actively recruiting participants. Contact the research team at xurh@syscc.org.cn for enrollment information.
Where is the NCT07653685 trial being conducted?
This trial is being conducted at Beijing, China, Chongqing, China, Lanzhou, China, Foshan, China and 11 additional locations.
Who is sponsoring the NCT07653685 clinical trial?
NCT07653685 is sponsored by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.. The trial plans to enroll 71 participants.
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