The goal of this clinical trial is to learn the efficaty and safety of BC001 in combination with Sintilimab and XELOX in treating patients with advanced or metastatic GC/GEJ.
Participants will:
Be administered with BC001, Sintilimab and Oxaliplatin once every three weeks for up to 24 months or until disease progression as per RECIST 1.1 or withdrawal from this study.
Take Capecitabine once daily in the first two weeks of each three-week treatment cycle for up to 24 months or until disease progression as per RECIST 1.1 or withdrawal from this study.
Subjects must be able to understand and voluntarily sign the written informed consent.
Subjects must be willing and able to complete the study procedures and follow-up examinations.
Male or female subjects aged between 18 and 75 years old (including 18 and 75 years old).
HER-2 negative patients with advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJ) (according to the 8th edition of AJCC/UICC TNM staging) confirmed by histopathology or cytopathology, who have never received systemic treatment before (the time interval from the end of previous neoadjuvant treatment/adjuvant treatment to the recurrence of the disease > 6 months will be regarded as untreated).
Subjects who have undergone major organ surgical operations (excluding needle biopsy) or had significant trauma within 4 weeks prior to the first use of the study drug, or who need to undergo elective surgeries during the trial period.
Subjects whose original lesions have invaded the central nervous system (CNS) with symptoms, are unstable or require high-dose steroids (≥10mg dexamethasone or equivalent dose) to achieve control.
Subjects suffering from other primary malignancies, except for malignancies with low metastasis risk and low death risk (5-year survival rate > 90%), such as malignancies that have been cured and have not relapsed within 3 years before enrollment in the study; completely resected basal cell and squamous cell skin cancers; completely resected carcinomas in situ of any type.
Subjects with active infections (such as viral, bacterial or fungal infections) that require systemic treatment.
Single group
BC001+Sintilimab+XELOX
Biological/Vaccinepatients will be given : BC001 8mg/kg, 12mg/kg or 16mg/kg intravenously once every three weeks; Sintilimab 3mg/kg（body weight\<60kg）or 200mg（body weight≥60kg）intravenously once every three weeks; Oxaliplatin 130mg/m2 intravenously once every three weeks; Capecitabine 1000mg/m2 orally once daily in the first two weeks of each three-week treatment cycle.
Adverse events
The frequency, severity of adverse events during the trial.
Maximum tolerated dose（dose escalation phase）
Recommended Phase 2 Dose(expansion phase)
Maximum Plasma Concentration (Cmax)
VEGF concentration in serum
Immunogenicity
Anti-BC001 antibody.
Objective response rate (ORR)
Defined as the proportion of patients who have a complete response (CR) or a partial response (PR) per RECIST 1.1.
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Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd.
Lead sponsor
Peking University Cancer Hospital & Institute
Collaborator
