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Active, Not Recruiting

NCT Number: NCT05002127

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Icon Cancer Centre Southport, Southport, Queensland, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 central nervous system (CNS) metastases or leptomeningeal disease requiring steroids.
  • Prior treatment with any anti-CD47 or anti-SIRPα agent.
  • Prior treatment with ramucirumab.

Treatment and study plan

Evorpacept (ALX148)

Drug

IV Q2W

Trastuzumab

Drug

IV Q2W

Other names: Herceptin

Ramucirumab

Drug

IV Q2W

Other names: Cyramza

paclitaxel

Drug

IV Days 1, 8, and 15 of a 28-day cycle

Other names: Taxol

Primary outcomes

  1. Phase 2

    Time frame: Last randomized patient on study at least 16 weeks

    Percentage of patients with objective response per RECIST 1.1

  2. Phase 3

    Time frame: From the date of randomization to the date of death (due to any cause), up to 36 months postdose

    Overall Survival

Sponsors and collaborators

Lead sponsor

ALX Oncology Inc.

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Aug 12, 2021
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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