NCT06492317

RC48 Plus AK104 as First-line Treatment for HER2-overexpressing Advanced Gastric Cancer

A Prospective, Single-center, Phase II Clinical Study of First-line Treatment for HER2 (Human Epidermal Growth Factor Receptor 2) Overexpressing Advanced Gastric Cancer With Disitamab Vedotin in Combination With Cadonilimab

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: The First Affiliated Hospital of Zhengzhou University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A single-arm, single-center phase II trial study to assess the efficacy and safety of disitamab vedotin plus cadonilimab as first-line therapy for HER2-overexpressing advanced stomach carcinoma

Detailed description

This study is a prospective, single-arm, single-center phase II trial. The purpose of the trial is evaluated Disitamab Vedotin (RC48) plus Cadonilimab (AK104) as first-line therapy for HER2-overexpressing advanced stomach carcinoma, and also check the adverse events (AEs) when participants are administered the combination treatment regimen. This study will include patients with HER2-overexpressing, locally advanced unresectable or metastatic gastric/gastroesophageal junction cancer who have not previously received systemic treatment including chemotherapy, targeted therapy, and immunotherapy. Enrolled patients will be treated with disitamab vedotin (2.5mg/kg, D1, ivdrip, Q2W) combined with cadonilimab (6mg/kg, D1, ivdrip, Q2W) until progressive disease (PD) or intolerable toxicity.

Conditions

• HER2-positive Gastric Cancer

Interventions

Type	Name	Description
DRUG	Disitamab Vedotin	Disitamab Vedotin: 2.5mg/kg, d1, ivdrip, Q2W (every 2 weeks)
DRUG	Cadonilimab	Cadonilimab: 6mg/kg, d1, ivdrip, Q2W (every 2 weeks)

Timeline

• Start date: 2024-07-06
• Primary completion: 2026-07-06
• Completion: 2027-07-06
• First posted: 2024-07-09
• Last updated: 2024-07-09

Locations

1 site across 1 country: China