ACTIVE_NOT_RECRUITING

A Study of Evorpacept (ALX148) in Patients With Advanced HER2+ Gastric Cancer (ASPEN-06)

Talk to us

Conditions

Gastric CancerGastroesophageal Junction AdenocarcinomaGastric AdenocarcinomaALX148CD47SIRPαGastricGastroesophagealGEJHER2 positiveRamucirumabEvorpacept

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2022-01-15
Study Completion:2028-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05002127

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * Adequate Bone Marrow Function.
  3. * Adequate Renal \& Liver Function.
  4. * Adequate Performance Status
  1. * Patients with known symptomatic central nervous system (CNS) metastases or leptomeningeal disease requiring steroids.
  2. * Prior treatment with any anti-CD47 or anti-SIRPα agent.
  3. * Prior treatment with ramucirumab.

Contacts and Locations

Study Locations (Sites)

The Oncology Institute of Hope & Innovation
Anaheim, California, 92801
United States
University of California Los Angeles
Los Angeles, California, 90095
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
NEXT Virginia
Fairfax, Virginia, 22031
United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: ALX Oncology Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-15
Study Completion Date2028-08

Study Record Updates

Study Start Date2022-01-15
Study Completion Date2028-08

Terms related to this study

Keywords Provided by Researchers

  • ALX148
  • CD47
  • SIRPα
  • Gastric
  • Gastroesophageal
  • GEJ
  • HER2 positive
  • Ramucirumab
  • Evorpacept

Additional Relevant MeSH Terms

  • Gastric Cancer
  • Gastroesophageal Junction Adenocarcinoma
  • Gastric Adenocarcinoma