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

12 juni 2026 bijgewerkt door: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

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).

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

71

Fase

  • Fase 2
  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100034
        • Peking University First Hospital
        • Contact:
    • Gansu
      • Lanzhou, Gansu, China, 730050
        • Gansu Provincial Tumor Hospital
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China, 530000
        • Guangxi Zhuang Autonomous Region Cancer Hospital
        • Contact:
    • Guizhou
      • Zunyi, Guizhou, China, 563000
        • The Affiliated Hospital of Zunyi Medical University
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • Harbin Medical University Cancer Hospital
        • Contact:
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450000
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
      • Zhengzhou, Henan, China, 450000
        • Henan Cancer Hospital
        • Contact:
      • Zhengzhou, Henan, China, 450000
        • The Third People's Hospital of Zhengzhou
        • Contact:
    • Hubei
      • Jingzhou, Hubei, China, 434099
        • Jingzhou First People's Hospital
        • Contact:
      • Wuhan, Hubei, China, 430022
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410013
        • Hunan Cancer Hospital
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Zhongda Hospital Southeast University
        • Contact:
      • Nanjing, Jiangsu, China, 210000
        • Jiangsu Provincial Cancer Hospital
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University
        • Contact:
      • Changchun, Jilin, China, 130021
        • Jilin cancer hospital
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110000
        • Liaoning Cancer Hospital & Institute
        • Contact:
    • Shaanxi
      • Xi'an, Shaanxi, China, 710000
        • The First Affiliated Hospital of Xi'an Jiaotong University Medical College
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200127
        • Renji Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:
    • Shanxi
      • Xi’an, Shanxi, China, 710000
        • The Second Affiliated Hospital of Air Force Medical University
        • Contact:
      • Xi’an, Shanxi, China, 710000
        • The First Affiliated Hospital of Air Force Medical University
        • Contact:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300121
        • Tianjin Union Medical Center
        • Contact:
          • Mingqing Zhang, Doctor
          • Telefoonnummer: 15122875158
          • E-mail: zmq1003@163.com
      • Tianjin, Tianjin Municipality, China, 300202
        • Tianjin Medical University Cancer Institute & Hospital
        • Contact:
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830054
        • Xinjiang Medical University Affiliated Tumor Hospital
        • Contact:
    • Zhejiang
      • Lishui, Zhejiang, China, 323000
        • Lishui Municipal Central Hospital
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: TQB2930 injection + Oxaliplatin injection + Capecitabine tablets + Bevacizumab injection
Geneesmiddel: 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.
Actieve vergelijker: TQB2930 injection + Oxaliplatin injection + Capecitabine tablets
Geneesmiddel: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Recommended Phase 2 Dose
Tijdsspanne: Baseline up to 21 days
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)
Tijdsspanne: 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)
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
Tijdsspanne: Baseline up to 24 months
The proportion of patients achieving complete response and partial response among the total evaluable cases.
Baseline up to 24 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Half-life
Tijdsspanne: Baseline up to 24 months
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
Tijdsspanne: Baseline up to 24 months
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
Tijdsspanne: Baseline up to 24 months
The rate at which the drug is cleared from the body.
Baseline up to 24 months
Apparent terminal volume of distribution
Tijdsspanne: Baseline up to 24 months
Describe the drug distribution in the body.
Baseline up to 24 months
Trough plasma concentration
Tijdsspanne: Baseline up to 24 months
Minimum plasma drug concentration level at the end of the dosing interval (before the next dosing).
Baseline up to 24 months
Disease Control Rate
Tijdsspanne: Baseline up to 24 months
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
Tijdsspanne: Baseline up to 24 months
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
Tijdsspanne: Baseline up to 24 months
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
Tijdsspanne: Baseline up to 24 months
The time from the start of initial treatment to death from any cause.
Baseline up to 24 months
Anti-Drug Antibodies (ADA) incidence
Tijdsspanne: Baseline up to 24 months
Proportion of anti-drug antibody produced in the population of patients using the drug.
Baseline up to 24 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juli 2026

Primaire voltooiing (Geschat)

1 juni 2027

Studie voltooiing (Geschat)

1 december 2028

Studieregistratiedata

Eerst ingediend

12 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

12 juni 2026

Eerst geplaatst (Werkelijk)

17 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

12 juni 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • TQB2930-Ib/II-02

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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