drugset / Trial / NCT05894824

T-Dxd in Combination With Ramucirumab as HER2 Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

NCT05894824

Phase 1/2 Recruiting 58 enrolled Yonsei University
NaSingle-groupOpen-labelTreatment

Summary

This is a Phase Ib/II study to identify the RP2D of T-DXd combination with Ram and to assess the safety and clinical efficacy of this combined treatment in advanced gastric cancer. The study will be conducted in two parts: Phase Ib dose escalation study to determine the MTD and RP2D of T-DXd combination and Ram, and Phase II to further evaluate the safety and tolerability of T-DXd combinations with Ram at the RP2D and determine anti-tumor activity.

Timeline

Start
2024-02-05
Primary completion
2025-12-01
Completion
2026-01-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Ramucirumab Monoclonal antibody 8 mg/kg Intravenous
Subject Trastuzmab deruxtecan Unknown 4.4 mg/kg Intravenous
Subject Trastuzmab deruxtecan Unknown 6.4 mg/kg Intravenous