drugset / Trial / NCT05894824
T-Dxd in Combination With Ramucirumab as HER2 Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |