RecruitingPhase 1NCT06773312

BC001 in Combination with Sintilimab and XELOX in the Treatment of HER-2 Negative Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma.

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).

Sponsor

Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd.

Enrollment

80 participants

Start Date

Feb 28, 2025

Study Type

INTERVENTIONAL

Conditions

Gastroesophageal Junction Adenocarcinoma Advanced or Metastatic Gastric Cancer

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of BC001 (a new antibody drug), sintilimab (an immunotherapy drug), and XELOX (a standard chemotherapy regimen) as a first-line treatment for people with advanced or metastatic gastric (stomach) cancer or gastroesophageal junction cancer that is HER2-negative. **You may be eligible if...** - You are 18–75 years old with confirmed HER2-negative advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma - You have not received prior systemic treatment for advanced disease - You have measurable disease on imaging - Your general health and organ function are adequate **You may NOT be eligible if...** - You had major surgery or significant trauma within the past 4 weeks - Your cancer has spread to the brain or spinal cord causing symptoms - You have active autoimmune disease requiring systemic treatment - You have active hepatitis B, hepatitis C, or HIV - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALBC001+Sintilimab+XELOX

patients 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.