Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

A Phase 2/3 Study of Evorpacept (ALX148) in Combination With Trastuzumab, Ramucirumab, and Paclitaxel in Patients With Advanced HER2-overexpressing gastric/GEJ adenocarcinoma.

Official Title

A Phase 2/3 Study of Evorpacept (ALX148) in Patients With Advanced HER2-Overexpressing Gastric/Gastroesophageal Junction Adenocarcinoma (ASPEN-06)

Details

This is a randomized phase 2 (open-label) / 3 (double-blind), international, multi-center study of patients with metastatic HER2-overexpressing gastric/GEJ adenocarcinoma that has progressed on or after prior HER2-directed therapy and fluoropyrimidine- or platinum-containing chemotherapy and are suitable for chemotherapy (2nd-line or 3rd-line). Approximately 450 adult patients are expected to be enrolled in the study across both phases.

Keywords

Gastric Cancer Gastroesophageal Junction Adenocarcinoma Gastric Adenocarcinoma ALX148 CD47 SIRPα Gastric Gastroesophageal GEJ HER2 positive Ramucirumab Evorpacept Adenocarcinoma Stomach Neoplasms Esophageal Neoplasms Paclitaxel Trastuzumab Evorpacept (ALX148)

Eligibility

You can join if…

Open to people ages 18 years and up

  • HER2-overexpressing advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma that has progressed on or after a prior HER2-directed agent and fluoropyrimidine- or platinum-containing chemotherapy (2nd-line or 3rd-line)
  • Adequate Bone Marrow Function.
  • Adequate Renal & Liver Function.
  • Adequate Performance Status

You CAN'T join if...

  • Patients with known symptomatic CNS metastases or leptomeningeal disease requiring steroids.
  • Prior treatment with any anti-CD47 or anti-SIRPα agent.
  • Prior treatment with ramucirumab.

Locations

  • The Oncology Institute of Hope & Innovation accepting new patients
    Anaheim California 92801 United States
  • Vanderbilt University Medical Center accepting new patients
    Nashville Tennessee 37232 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
ALX Oncology Inc.
ID
NCT05002127
Phase
Phase 2/3 research study
Study Type
Interventional
Participants
Expecting 450 study participants
Last Updated