A Phase I Clinical Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of BC001 in Combination with Sintilimab and XELOX in the Treatment of HER-2 Negative Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma (GC/GEJ).
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).
• According to RECIST version 1.1, there must be at least one measurable tumor lesion shown by CT or MRI examination.
• Subjects with normal oral intake.
• ECOG (Eastern Cooperative Oncology Group) performance score of 0 - 1.
• Expected survival period is greater than 3 months.
• There is no serious hematological, hepatic or renal function abnormality, meeting the following laboratory test results: the absolute neutrophil count (ANC) should be ≥1.5×10⁹/L, platelet (PLT) ≥100×10⁹/L, and hemoglobin (HGB) ≥90g/L; Serum creatinine (Cr) ≤1.5× the upper limit of normal range (ULN). When Cr \> 1.5×ULN, , and creatinine clearance rate (Ccr)≥ 60mL/min(calculated according to the Cockcroft - Gault formula); the qualitative urine protein should be ≤1 +, or if the qualitative urine protein ≥2 +, the 24-hour urine protein \< 1g; total bilirubin (TBIL) ≤1.5×ULN or ≤3×ULN (for patients with liver cancer or liver metastases), alanine aminotransferase (AST) and aspartate aminotransferase (ALT) ≤3.0×ULN or ≤5×ULN (for patients with liver cancer or liver metastases), alkaline phosphatase (ALP) ≤2.5×ULN or ≤5×ULN (for patients with liver cancer or liver metastases); the international normalized ratio (INR) or prothrombin time T (PT) ≤1.5×ULN, and the activated partial thromboplastin time (APTT) ≤1.5×ULN.
⁃ Male or female subjects should take effective contraceptive measures during the treatment period and within 6 months after the last dose administration.