A Study of Evorpacept (ALX148) in Patients with Advanced HER2+ Gastric Cancer (ASPEN-06)
Sponsor: ALX Oncology Inc.
ClinicalTrials ID:NCT05002127
This Phase 2/3 study evaluates Evorpacept with trastuzumab, ramucirumab, and paclitaxel in patients with metastatic HER2+ gastric/GEJ adenocarcinoma post-HER2 therapy and chemotherapy. Enrolling 450 adults, it requires adequate organ function and excludes those with CNS metastases or prior anti-CD47/SIRPα or ramucirumab treatment. Interventions are administered intravenously.
Patient Parameters
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Program Overview
A Phase 2/3 Study of Evorpacept (ALX148) in Combination With Trastuzumab, Ramucirumab, and Paclitaxel in Patients With Advanced HER2-overexpressing gastric/GEJ adenocarcinoma.
Description
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| The Oncology Institute of Hope & Innovation | 92801 | Anaheim | California |
| University of California Los Angeles | 90095 | Los Angeles | California |
| Vanderbilt University Medical Center | 37232 | Nashville | Tennessee |
| NEXT Virginia | 22031 | Fairfax | Virginia |
| Fred Hutchinson Cancer Center | 98109 | Seattle | Washington |
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