NCT07529613

Trastuzumab Deruxtecan Plus Nivolumab Plus Capecitabine Plus Oxaliplatin for HER2 Low Gastric and Gastroesophageal Junction Adenocarcinoma

An Open Label Phase 1b/2 Study to Evaluate Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd) Plus Nivolumab Plus Capecitabine Plus Oxaliplatin for Patients With HER2-Low Gastric and Gastroesophageal Junction Adenocarcinoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: National Cancer Center Hospital East · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and tolerability of the combination therapy of T-DXd, nivolumab, and chemotherapy in patients with untreated HER2-low gastric or gastroesophageal junction adenocarcinoma, and to determine the recommended dose. Subsequently, the efficacy and safety at the recommended dose will be assessed.

Conditions

• Gastric Adenocarcinoma
• Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	T-DXd	T-DXd (4.4mg/kg, intravenous, q3w)
DRUG	Nivolumab	Nivolumab (360 mg, intravenous, q3w)
DRUG	Capecitabine	Capecitabine (750mg/m2 twice daily, days 1-14, orally)
DRUG	Oxaliplatin	Oxaliplatin (70mg/m2, intravenous, q3w)

Timeline

• Start date: 2023-12-20
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2026-04-14
• Last updated: 2026-04-14

Locations

1 site across 1 country: Japan