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

12 giugno 2026 aggiornato da: 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).

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

71

Fase

  • Fase 2
  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Cina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Cina, 100034
        • Peking University First Hospital
        • Contatto:
    • Gansu
      • Lanzhou, Gansu, Cina, 730050
        • Gansu Provincial Tumor Hospital
        • Contatto:
    • Guangxi
      • Nanning, Guangxi, Cina, 530000
        • Guangxi Zhuang Autonomous Region Cancer Hospital
        • Contatto:
          • Rong Liang, Doctor
          • Numero di telefono: 18677070811
          • Email: 53371159@qq.com
    • Guizhou
      • Zunyi, Guizhou, Cina, 563000
        • The Affiliated Hospital of Zunyi Medical University
        • Contatto:
    • Heilongjiang
      • Harbin, Heilongjiang, Cina, 150000
        • Harbin Medical University Cancer Hospital
        • Contatto:
        • Contatto:
    • Henan
      • Zhengzhou, Henan, Cina, 450000
        • The First Affiliated Hospital of Zhengzhou University
        • Contatto:
      • Zhengzhou, Henan, Cina, 450000
        • Henan Cancer Hospital
        • Contatto:
      • Zhengzhou, Henan, Cina, 450000
        • The Third People's Hospital of Zhengzhou
        • Contatto:
          • HaiCun Wang, Master
          • Numero di telefono: 13803833783
          • Email: whc1975@126.com
    • Hubei
      • Jingzhou, Hubei, Cina, 434099
        • Jingzhou First People's Hospital
        • Contatto:
      • Wuhan, Hubei, Cina, 430022
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contatto:
    • Hunan
      • Changsha, Hunan, Cina, 410013
        • Hunan Cancer Hospital
        • Contatto:
    • Jiangsu
      • Nanjing, Jiangsu, Cina, 210009
        • Zhongda Hospital Southeast University
        • Contatto:
      • Nanjing, Jiangsu, Cina, 210000
        • Jiangsu Provincial Cancer Hospital
        • Contatto:
    • Jilin
      • Changchun, Jilin, Cina, 130021
        • The First Hospital of Jilin University
        • Contatto:
      • Changchun, Jilin, Cina, 130021
        • Jilin Cancer Hospital
        • Contatto:
    • Liaoning
      • Shenyang, Liaoning, Cina, 110000
        • Liaoning Cancer Hospital & Institute
        • Contatto:
    • Shaanxi
      • Xi'an, Shaanxi, Cina, 710000
        • The First Affiliated Hospital of Xi'an Jiaotong University Medical College
        • Contatto:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Cina, 200127
        • Renji Hospital, Shanghai Jiao Tong University School of Medicine
        • Contatto:
    • Shanxi
      • Xi’an, Shanxi, Cina, 710000
        • The Second Affiliated Hospital of Air Force Medical University
        • Contatto:
          • Haichuan Su, Doctor
          • Numero di telefono: 18629190366
          • Email: cntdgcp@163.com
      • Xi’an, Shanxi, Cina, 710000
        • The First Affiliated Hospital of Air Force Medical University
        • Contatto:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Cina, 300121
        • Tianjin Union Medical Center
        • Contatto:
          • Mingqing Zhang, Doctor
          • Numero di telefono: 15122875158
          • Email: zmq1003@163.com
      • Tianjin, Tianjin Municipality, Cina, 300202
        • Tianjin Medical University Cancer Institute & Hospital
        • Contatto:
          • Zhanyu Pan, Master
          • Numero di telefono: 18622221256
          • Email: tjpanzy@126.com
    • Xinjiang
      • Ürümqi, Xinjiang, Cina, 830054
        • Xinjiang Medical University Affiliated Tumor Hospital
        • Contatto:
    • Zhejiang
      • Lishui, Zhejiang, Cina, 323000
        • Lishui Municipal Central Hospital
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: TQB2930 injection + Oxaliplatin injection + Capecitabine tablets + Bevacizumab injection
Droga: 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.
Comparatore attivo: TQB2930 injection + Oxaliplatin injection + Capecitabine tablets
Droga: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Recommended Phase 2 Dose
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Half-life
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline up to 24 months
Describe the drug distribution in the body.
Baseline up to 24 months
Trough plasma concentration
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline up to 24 months
Proportion of anti-drug antibody produced in the population of patients using the drug.
Baseline up to 24 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

1 giugno 2027

Completamento dello studio (Stimato)

1 dicembre 2028

Date di iscrizione allo studio

Primo inviato

12 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

12 giugno 2026

Primo Inserito (Effettivo)

17 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 giugno 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • TQB2930-Ib/II-02

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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