Imugene has concluded patient enrolment in a Phase lb clinical trial of its HER-Vaxx cancer vaccine IMU-131 for the treatment of patients with HER-2 gastric cancer.
The open-label, multi-centre, dose-escalation trial has enrolled 18 patients.
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It indents to evaluate three different doses of IMU-131 in combination with current standard of care chemotherapy Cisplatin and either Fluorouracil or Capecitabine.
The primary objectives of the trial comprise the safety, tolerability, immunogenicity and recommended phase 2 dose (RP2D) of IMU-131.
A cohort review committee will determine the RP2D, which will be investigated in a dose-expansion Phase ll trial.
Imugene managing director and CEO Leslie Chong said: “Clinicians at the trial sites observed no toxicities and report all vaccinated patients developed immune responses and antibodies to the HER-2 protein which encourages cancer growth.
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By GlobalData“We look forward to reporting on further milestones and completing the analysis in the coming months.”
“Completion of recruitment is an important milestone for the study and the many medical professionals seeking treatments for patients with advanced gastric cancer who often have very few medical options.”
Imugene has already started work on the Phase ll trial, which is designed to examine the efficacy, safety and immune response of the RP2D of IMU-131 in 68 gastric cancer patients with metastatic gastric cancer overexpressing the HER-2 protein.
In the trial, two cohorts of patients will be randomised to receive either IMU-131 plus standard-of-care (chemotherapy) or standard-of-care alone.
The trial’s endpoints are progression-free survival and overall survival.
Both the Phase lb and Phase ll trial are being conducted across Asia and Eastern Europe.
