NCT06776770

A Phase Ib/II Study of Adebrelimab in Combination with Capecitabine and Oxaliplatin in Cancer

A Phase Ib/II Study of Adebrelimab in Combination with Capecitabine and Oxaliplatin in Previously Untreated Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this study, the combination of Adebrelimab (PD-L1 monoclonal antibody) on the basis of standard treatment (two-drug chemotherapy regimen of fluorouracil and platinum drugs) may enhance the immune response in order to enhance the killing effect on tumor cells and bring survival benefits to patients with advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma.

Detailed description

This study is divided into two phases: Phase Ib is a study on the tolerance and safety of Adebrelimab combined with capecitabine and oxaliplatin in the treatment of patients with advanced solid tumors; Phase II is a single-arm, open-label clinical study to observe and evaluate the improvement of objective response rate (ORR) in advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma treated with adebrelimab combination therapy. A total of 52 subjects are expected to be enrolled in this study.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Adebrelimab	Phase I: Cohort 1: Adebrelimab 10 mg/kg Q3W plus capecitabine and oxaliplatin (XELOX regimen); 21-day treatment cycle; Cohort 2: Adebrelimab 1200 mg or 20 mg/kg Q3W plus capecitabine and oxaliplatin (XELOX regimen); 21-day treatment cycle. Phase II: Adebrelimab (RP2D, Q3W) + (XELOX regimen), with a 3-week (21-day) treatment cycle. XELOX regimen：Oxaliplatin 130 mg/m2 iv.gtt d1，Capecitabine 1,000 mg/m2 p.o.b.i.d.d1\~14.

Timeline

• Start date: 2024-08-03
• Primary completion: 2026-09-30
• Completion: 2026-12-31
• First posted: 2025-01-15
• Last updated: 2025-01-15

Locations

1 site across 1 country: China