NCT06773312

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).

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This trial is an open-label Phase I clinical trial, which is divided into the dose escalation phase and the dose expansion phase. It aims to evaluate the safety, tolerability, pharmacokinetic (PK) characteristics and preliminary efficacy of BC001 in combination with Sintilimab and XELOX, and to determine the recommended Phase 2 dose (RP2D) and preliminary efficacy of BC001 in combination with Sintilimab and XELOX in the treatment of patients with HER-2 negative advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJ) who have never received systemic treatment before. The dose escalation phase adopts a 3+3 dose escalation design and three dose groups are planned initially. The dose expansion study will recommend two appropriate dose groups based on data from the dose escalation phase, and 30 subjects planned to be enrolled in each group. According to the safety and efficacy of each group, one of the doses will be selected and determined as the recommended Phase 2 dose (RP2D).

Conditions

• Advanced or Metastatic Gastric Cancer
• Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
BIOLOGICAL	BC001+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.

Timeline

• Start date: 2025-02-28
• Primary completion: 2026-10-01
• Completion: 2027-04-01
• First posted: 2025-01-14
• Last updated: 2025-03-10

Locations

1 site across 1 country: China