Study on Evorpacept (ALX148) for Patients with Advanced HER2+ Gastric Cancer

Sponsor: ALX Oncology Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05002127

Provider View

This clinical trial is testing a new treatment using Evorpacept (ALX148) combined with other cancer drugs to see if it can help patients with advanced HER2+ gastric cancer that has worsened after previous treatments.

Patient Parameters

Program Overview

The study is investigating whether a new drug, Evorpacept (ALX148), when used with Trastuzumab, Ramucirumab, and Paclitaxel, can help treat patients with advanced gastric or gastroesophageal junction (GEJ) cancer that overexpresses HER2. This cancer has progressed despite previous treatments targeting HER2 and chemotherapy containing fluoropyrimidine or platinum. The trial is international and involves multiple centers, aiming to enroll about 450 adult patients in two phases.

Description

This clinical trial is designed to test the effectiveness of a new treatment combination for patients with advanced gastric or gastroesophageal junction (GEJ) cancer that overexpresses HER2. The study is divided into two parts: Phase 2, which is open-label, meaning both doctors and patients know what treatment is being given, and Phase 3, which is double-blind, meaning neither doctors nor patients know who is receiving the new treatment or a standard treatment. The trial will include patients whose cancer has worsened after previous treatments that targeted HER2 and included chemotherapy with fluoropyrimidine or platinum. The study will take place in multiple countries and aims to enroll around 450 adult participants across both phases.

Eligibility Criteria

Inclusion Criteria

  • Have advanced or metastatic gastric or gastroesophageal junction (GEJ) cancer that overexpresses HER2 and has worsened after previous HER2-targeted treatment and chemotherapy with fluoropyrimidine or platinum.
  • Have good bone marrow function.
  • Have good kidney and liver function.
  • Be in good overall health, as determined by a performance status assessment.

Exclusion Criteria

  • Have known brain metastases or cancer in the membranes surrounding the brain that require steroid treatment.
  • Have previously been treated with any drugs targeting CD47 or SIRPα.
  • Have previously been treated with the drug ramucirumab.

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