drugset
drugset / Trial / NCT06773312

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

NCT06773312 ↗

Phase 1 Recruiting 80 enrolled Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd. Peking University Cancer Hospital & Institute · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-02-28
Primary completion
2026-10
Completion
2027-04

Drugs

EvaluationDrugModalityDoseRoute
Subject BC001 Unknown 8 mg/kg Intravenous
Subject BC001 Unknown 12 mg/kg Intravenous
Subject BC001 Unknown 16 mg/kg Intravenous
Background Capecitabine Small molecule 1000 mg/m2 Oral
Background Oxaliplatin Small molecule 130 mg/m2 Intravenous
Background Sintilimab Monoclonal antibody 3 mg/kg Intravenous
Background Sintilimab Monoclonal antibody 200 mg Intravenous

Indications

gastroesophageal junction adenocarcinoma