NCT07653685招募中1 期
A Phase Ib/II Clinical Study to Evaluate the Efficacy and Safety of TQB2930 Injection and Chemotherapy With or Without Bevacizumab in Participants With HER2-Abnormally Expressed Unresectable Locally Advanced or Metastatic Colorectal Cancer.
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.31 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2026年9月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 71
- 试验地点
- 31
- 主要终点
- Objective Response Rate
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
TQB2930 injection +chemotherapy + Bevacizumab injection
Experimental
干预措施: TQB2930 injection +(Oxaliplatin for injection + Capecitabine tablets)/( Irinotecan hydrochloride injection+ Capecitabine tablets)+Bevacizumab injection (Drug)
TQB2930 injection +chemotherapy
Active Comparator
干预措施: TQB2930 injection +(Oxaliplatin for injection + Capecitabine tablets)/( Irinotecan hydrochloride injection+ Capecitabine tablets) (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: Baseline up to 24 months
The proportion of participants achieving complete response and partial response among the total evaluable cases.
Adverse event (AE)
时间窗: From the participants 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.
Recommended Phase 2 Dose
时间窗: 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.
次要结局
- Disease Control Rate(Baseline up to 24 months)
- Half-life(Baseline up to 24 months)
- Plasma concentration-time profiles(Baseline up to 24 months)
- Apparent clearance(Baseline up to 24 months)
- Apparent terminal volume of distribution(Baseline up to 24 months)
- Trough plasma concentration(Baseline up to 24 months)
- Duration Of Response(Baseline up to 24 months)
- Progression Free Survival(Baseline up to 24 months)
- Overall Survival(Baseline up to 24 months)
- Anti-Drug Antibodies (ADA) incidence(Baseline up to 24 months)
研究者
研究点 (31)
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