RecruitingPhase 1Phase 2NCT05894824

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

Sponsor

Yonsei University

Enrollment

58 participants

Start Date

Feb 5, 2024

Study Type

INTERVENTIONAL

Conditions

Gastric Cancer GastroEsophageal Junction (GEJ) Cancer

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.

Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether combining T-DXd (trastuzumab deruxtecan, an antibody-drug conjugate targeting HER2) with ramucirumab (a drug that blocks blood vessel growth in tumors) is safe and effective for people with HER2-low gastric or gastroesophageal junction cancer. **You may be eligible if...** - You are 19 or older - You have confirmed metastatic or locally advanced gastric or gastroesophageal junction cancer with HER2-low expression (1+ by staining, or 2+ without gene amplification) - You have given written consent **You may NOT be eligible if...** - You have HER2-negative (score 0) or HER2-high (score 3+) cancer - Your cancer is not gastric or gastroesophageal in origin - You are under 19 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGT-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