drugset / Trial / NCT07529613

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

NCT07529613

Phase 1/2 Completed 30 enrolled National Cancer Center Hospital East
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2023-12-20
Primary completion
2025-12-31
Completion
2025-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 750 mg/m2 Oral
Subject Nivolumab Monoclonal antibody 360 mg Intravenous
Subject Oxaliplatin Small molecule 70 mg/m2 Intravenous
Subject Trastuzumab deruxtecan Monoclonal antibody 4.4 mg/kg Intravenous