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

Phase 2

Active, not recruiting

• Conditions: Gastric Cancer; Gastroesophageal Junction Adenocarcinoma; Gastric Adenocarcinoma
• Interventions: Drug: Evorpacept (ALX148); Drug: Trastuzumab; Drug: Ramucirumab; Drug: Paclitaxel

• Registration Number: NCT05002127
• Lead Sponsor: ALX Oncology Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2021-07-27
• Study First Submitted QC: 2021-08-04
• Study First Posted: 2021-08-12
• Study Start: 2022-01-15
• Primary Completion: 2024-05-24
• Disposition First Posted: 2024-09-19
• Disposition First Submitted: 2025-05-23
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-10
• Last Update Posted: 2025-06-12
• Study Completion: 2028-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 450

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phase 2 - Arm A	Evorpacept (ALX148)	Evorpacept (ALX148) 30 mg/kg every two weeks (Q2W) intravenous (IV), trastuzumab (initial dose of 6 mg/kg followed by 4 mg/kg) Q2W IV, ramucirumab 8 mg/kg Q2W IV, and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle.
Phase 2 - Arm A	Trastuzumab	Evorpacept (ALX148) 30 mg/kg every two weeks (Q2W) intravenous (IV), trastuzumab (initial dose of 6 mg/kg followed by 4 mg/kg) Q2W IV, ramucirumab 8 mg/kg Q2W IV, and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle.
Phase 2 - Arm A	Ramucirumab	Evorpacept (ALX148) 30 mg/kg every two weeks (Q2W) intravenous (IV), trastuzumab (initial dose of 6 mg/kg followed by 4 mg/kg) Q2W IV, ramucirumab 8 mg/kg Q2W IV, and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle.
Phase 2 - Arm A	Paclitaxel	Evorpacept (ALX148) 30 mg/kg every two weeks (Q2W) intravenous (IV), trastuzumab (initial dose of 6 mg/kg followed by 4 mg/kg) Q2W IV, ramucirumab 8 mg/kg Q2W IV, and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle.
Phase 2 - Arm B	Trastuzumab	Trastuzumab (initial dose of 6 mg/kg followed by 4 mg/kg) Q2W IV, ramucirumab 8 mg/kg Q2W IV, and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle.
Phase 2 - Arm B	Ramucirumab	Trastuzumab (initial dose of 6 mg/kg followed by 4 mg/kg) Q2W IV, ramucirumab 8 mg/kg Q2W IV, and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle.
Phase 2 - Arm B	Paclitaxel	Trastuzumab (initial dose of 6 mg/kg followed by 4 mg/kg) Q2W IV, ramucirumab 8 mg/kg Q2W IV, and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle.
Phase 3 - Arm A	Evorpacept (ALX148)	Evorpacept (ALX148) 30 mg/kg Q2W IV, trastuzumab (initial dose of 6 mg/kg followed by 4 mg/kg) Q2W IV, ramucirumab 8 mg/kg Q2W IV, and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle.
Phase 3 - Arm A	Trastuzumab	Evorpacept (ALX148) 30 mg/kg Q2W IV, trastuzumab (initial dose of 6 mg/kg followed by 4 mg/kg) Q2W IV, ramucirumab 8 mg/kg Q2W IV, and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle.
Phase 3 - Arm A	Ramucirumab	Evorpacept (ALX148) 30 mg/kg Q2W IV, trastuzumab (initial dose of 6 mg/kg followed by 4 mg/kg) Q2W IV, ramucirumab 8 mg/kg Q2W IV, and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle.
Phase 3 - Arm A	Paclitaxel	Evorpacept (ALX148) 30 mg/kg Q2W IV, trastuzumab (initial dose of 6 mg/kg followed by 4 mg/kg) Q2W IV, ramucirumab 8 mg/kg Q2W IV, and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle.
Phase 3 - Arm B	Ramucirumab	Ramucirumab 8 mg/kg Q2W IV and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle.
Phase 3 - Arm B	Paclitaxel	Ramucirumab 8 mg/kg Q2W IV and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle.

Primary Outcome Measures

Name	Time	Method
Phase 2	Last randomized patient on study at least 16 weeks	Percentage of patients with objective response per RECIST 1.1
Phase 3	From the date of randomization to the date of death (due to any cause), up to 36 months postdose	Overall Survival

Trial Locations

Locations (83)

The Oncology Institute of Hope & Innovation; 🇺🇸 Anaheim, California, United States

University of California Los Angeles; 🇺🇸 Los Angeles, California, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

NEXT Virginia; 🇺🇸 Fairfax, Virginia, United States

Fred Hutchinson Cancer Center; 🇺🇸 Seattle, Washington, United States

Icon Cancer Centre Southport; 🇦🇺 Southport, Queensland, Australia

Monash Medical Centre; 🇦🇺 Clayton, Victoria, Australia

Universitair Ziekenhuis Antwerpen; 🇧🇪 Antwerp, Belgium

Universitair Ziekenhuis Leuven - Campus Gasthuisberg; 🇧🇪 Leuven, Belgium

Centre Hospitalier Universitaire de Liège; 🇧🇪 Liège, Belgium

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