NCT05002127

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

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

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: ALX Oncology Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized phase 2 (open-label) / 3 (blinded), 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. The Sponsor has decided not to proceed with the Phase 3 portion of the study due to strategic considerations.

Conditions

• Gastric Cancer
• Gastroesophageal Junction Adenocarcinoma
• Gastric Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Evorpacept (ALX148)	IV Q2W
DRUG	Trastuzumab	IV Q2W
DRUG	Ramucirumab	IV Q2W
DRUG	Paclitaxel	IV Days 1, 8, and 15 of a 28-day cycle

Timeline

• Start date: 2022-01-15
• Primary completion: 2024-05-24
• Completion: 2026-06-01
• First posted: 2021-08-12
• Last updated: 2025-08-07

Locations

83 sites across 12 countries: United States, Australia, Belgium, Czechia, France, Italy, Japan, Singapore, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study