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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
71
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. Irinotecan hydrochloride injection inhibits topoisomerase-I via its active metabolite SN-38, prevents religation of DNA single-strand breaks, causes irreversible DNA double-strand damage and induces tumor cell apoptosis. Capecitabine inhibits thymidylate synthase (TS) and interferes with DNA synthesis. Bevacizumab blocks VEGF binding to receptors and inhibits tumor angiogenesis.
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. Irinotecan hydrochloride injection inhibits topoisomerase-I via its active metabolite SN-38, prevents religation of DNA single-strand breaks, causes irreversible DNA double-strand damage and induces tumor cell apoptosis. Capecitabine inhibits thymidylate synthase (TS) and interferes with DNA synthesis.
Peking University First Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGGansu Provincial Tumor Hospital
Lanzhou, Gansu, China
NOT_YET_RECRUITINGThe First People's Hospital of Foshan
Foshan, Guangdong, China
NOT_YET_RECRUITINGRecommended Phase 2 Dose
It refers to the safe and effective dose range that can be used for phase II study determined through phase I clinical trial.
Time frame: Baseline up to 21 days
Adverse event (AE)
Incidence and severity of adverse events.
Time frame: 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)
Objective Response Rate
The proportion of participants achieving complete response and partial response among the total evaluable cases.
Time frame: Baseline up to 24 months
Half-life
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.
Time frame: Baseline up to 24 months
Plasma concentration-time profiles
Total area covered under the curve plotted with time as X-axis and plasma concentration as Y-axis.
Time frame: Baseline up to 24 months
Apparent clearance
The rate at which the drug is cleared from the body.
Time frame: Baseline up to 24 months
Apparent terminal volume of distribution
Describe the drug distribution in the body.
Time frame: Baseline up to 24 months
Trough plasma concentration
Minimum plasma drug concentration level at the end of the dosing interval (before the next dosing).
Time frame: Baseline up to 24 months
Disease Control Rate
The percentage of participants with a complete response, partial response, or stable disease as determined by RECIST 1.1.
Time frame: Baseline up to 24 months
Duration Of Response
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.
Time frame: Baseline up to 24 months
Progression Free Survival
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.
Time frame: Baseline up to 24 months
Overall Survival
The time from the start of initial treatment to death from any cause.
Time frame: Baseline up to 24 months
Anti-Drug Antibodies (ADA) incidence
Proportion of anti-drug antibody produced in the population of patients using the drug.
Time frame: Baseline up to 24 months
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The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGGuangxi Zhuang Autonomous Region Cancer Hospital
Nanning, Guangxi, China
NOT_YET_RECRUITINGThe Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China
RECRUITINGHarbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
NOT_YET_RECRUITINGQiqihar First Hospital
Qiqihar, Heilongjiang, China
NOT_YET_RECRUITING...and 21 more locations