이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2026년 6월 12일 업데이트: 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).

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

71

단계

  • 2 단계
  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: TQB2930 injection + Oxaliplatin injection + Capecitabine tablets + Bevacizumab injection
의약품: 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.
활성 비교기: TQB2930 injection + Oxaliplatin injection + Capecitabine tablets
의약품: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Recommended Phase 2 Dose
기간: 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)
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Half-life
기간: 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
기간: 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
기간: 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
기간: Baseline up to 24 months
Describe the drug distribution in the body.
Baseline up to 24 months
Trough plasma concentration
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Baseline up to 24 months
Proportion of anti-drug antibody produced in the population of patients using the drug.
Baseline up to 24 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

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

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 7월 1일

기본 완료 (추정된)

2027년 6월 1일

연구 완료 (추정된)

2028년 12월 1일

연구 등록 날짜

최초 제출

2026년 6월 12일

QC 기준을 충족하는 최초 제출

2026년 6월 12일

처음 게시됨 (실제)

2026년 6월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 12일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • TQB2930-Ib/II-02

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

대장암에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Mexico

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다