NCT05894824

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

An Open Label, Single-arm, Multicenter Phase Ib/II Study to Evaluate the Safety and Efficacy of T-Dxd in Combination With Ramucirumab as a 2nd Line in Patients With HER2 Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 after first-line treatment. 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.

Conditions

• Gastric Cancer
• Gastroesophageal Junction (GEJ) Cancer

Interventions

Type	Name	Description
DRUG	T-Dxd(Trastuzmab deruxtecan), Ramucirumab	Phase Ib will use a standard 3+3 scheme with the planned doses of T-DXd (4.4\~6.4 mg/kg) once every 3 weeks in combination with Ramucirumab 8mg/kg administered once every 2 weeks. * Dosing Regimen * Trastruzumab deruxtecan : One IV infusion every 3 weeks on Day 1 of each 21-day cycle * Ramucirumab : One IV infusion on every 2 weeks on Day 1,15 of each 28-day cycle

Timeline

• Start date: 2024-02-05
• Primary completion: 2025-12-01
• Completion: 2026-01-01
• First posted: 2023-06-08
• Last updated: 2025-07-11

Locations

1 site across 1 country: South Korea