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

Sponsor
Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd.
Study ID
NCT06773312
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced or Metastatic Gastric Cancer
  • Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • BC001+Sintilimab+XELOX — BIOLOGICAL
    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.

Study Details

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.

Key Dates

First listed
Jan 14, 2025
Start date
Feb 28, 2025
Status verified
Mar 2025
Primary completion
Oct 31, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BC001+Sintilimab+XELOX
    BC001+Sintilimab+XELOX

Primary Outcome Measure

Adverse events [ Time Frame: Through study completion, assessed up to 2 years ]

Central Contacts

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