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

12 juin 2026 mis à jour par: 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).

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

71

Phase

  • Phase 2
  • La phase 1

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Ruihua Xu, Doctor
  • Numéro de téléphone: 020-87343468
  • E-mail: xurh@syscc.org.cn

Lieux d'étude

  • Chine
    • Beijing Municipality
      • Beijing, Beijing Municipality, Chine, 100034
        • Peking University First Hospital
        • Contact:
    • Gansu
      • Lanzhou, Gansu, Chine, 730050
        • Gansu Provincial Tumor Hospital
        • Contact:
    • Guangxi
      • Nanning, Guangxi, Chine, 530000
        • Guangxi Zhuang Autonomous Region Cancer Hospital
        • Contact:
          • Rong Liang, Doctor
          • Numéro de téléphone: 18677070811
          • E-mail: 53371159@qq.com
    • Guizhou
      • Zunyi, Guizhou, Chine, 563000
        • The Affiliated Hospital of Zunyi Medical University
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, Chine, 150000
        • Harbin Medical University Cancer Hospital
        • Contact:
        • Contact:
    • Henan
      • Zhengzhou, Henan, Chine, 450000
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
      • Zhengzhou, Henan, Chine, 450000
        • Henan Cancer Hospital
        • Contact:
      • Zhengzhou, Henan, Chine, 450000
        • The Third People's Hospital of Zhengzhou
        • Contact:
          • HaiCun Wang, Master
          • Numéro de téléphone: 13803833783
          • E-mail: whc1975@126.com
    • Hubei
      • Jingzhou, Hubei, Chine, 434099
        • Jingzhou First People's Hospital
        • Contact:
      • Wuhan, Hubei, Chine, 430022
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
    • Hunan
      • Changsha, Hunan, Chine, 410013
        • Hunan Cancer Hospital
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, Chine, 210009
        • Zhongda Hospital Southeast University
        • Contact:
      • Nanjing, Jiangsu, Chine, 210000
        • Jiangsu Provincial Cancer Hospital
        • Contact:
    • Jilin
      • Changchun, Jilin, Chine, 130021
        • The First Hospital of Jilin University
        • Contact:
      • Changchun, Jilin, Chine, 130021
        • Jilin cancer hospital
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, Chine, 110000
        • Liaoning Cancer Hospital & Institute
        • Contact:
    • Shaanxi
      • Xi'an, Shaanxi, Chine, 710000
        • The First Affiliated Hospital of Xi'an Jiaotong University Medical College
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Chine, 200127
        • Renji Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:
    • Shanxi
      • Xi’an, Shanxi, Chine, 710000
        • The Second Affiliated Hospital of Air Force Medical University
        • Contact:
          • Haichuan Su, Doctor
          • Numéro de téléphone: 18629190366
          • E-mail: cntdgcp@163.com
      • Xi’an, Shanxi, Chine, 710000
        • The First Affiliated Hospital of Air Force Medical University
        • Contact:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Chine, 300121
        • Tianjin Union Medical Center
        • Contact:
          • Mingqing Zhang, Doctor
          • Numéro de téléphone: 15122875158
          • E-mail: zmq1003@163.com
      • Tianjin, Tianjin Municipality, Chine, 300202
        • Tianjin Medical University Cancer Institute & Hospital
        • Contact:
          • Zhanyu Pan, Master
          • Numéro de téléphone: 18622221256
          • E-mail: tjpanzy@126.com
    • Xinjiang
      • Ürümqi, Xinjiang, Chine, 830054
        • Xinjiang Medical University Affiliated Tumor Hospital
        • Contact:
    • Zhejiang
      • Lishui, Zhejiang, Chine, 323000
        • Lishui Municipal Central Hospital
        • Contact:
          • Yanru Xie, Master
          • Numéro de téléphone: 13567615770
          • E-mail: 43437677@qq.com

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: TQB2930 injection + Oxaliplatin injection + Capecitabine tablets + Bevacizumab injection
Médicament: 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.
Comparateur actif: TQB2930 injection + Oxaliplatin injection + Capecitabine tablets
Médicament: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Recommended Phase 2 Dose
Délai: 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)
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Half-life
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline up to 24 months
Describe the drug distribution in the body.
Baseline up to 24 months
Trough plasma concentration
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline up to 24 months
Proportion of anti-drug antibody produced in the population of patients using the drug.
Baseline up to 24 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juillet 2026

Achèvement primaire (Estimé)

1 juin 2027

Achèvement de l'étude (Estimé)

1 décembre 2028

Dates d'inscription aux études

Première soumission

12 juin 2026

Première soumission répondant aux critères de contrôle qualité

12 juin 2026

Première publication (Réel)

17 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

17 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

12 juin 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • TQB2930-Ib/II-02

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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