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

NCT05002127 · tracked via the Priya Life Science USA tracker

Sponsor

ALX Oncology Inc.

Phase

Phase 2/3

Started

2022-01-15

Last updated

2025-08-07

Condition(s) studied

Gastric CancerGastroesophageal Junction AdenocarcinomaGastric Adenocarcinoma

Investigational drug(s) / intervention(s)

Evorpacept (ALX148)TrastuzumabRamucirumabPaclitaxel

Evorpacept (ALX148): IV Q2W

Trastuzumab: IV Q2W

Ramucirumab: IV Q2W

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

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

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 sites (83)

Facility	City	Region
The Oncology Institute of Hope & Innovation	Anaheim	California
University of California Los Angeles	Los Angeles	California
Vanderbilt University Medical Center	Nashville	Tennessee
NEXT Virginia	Fairfax	Virginia
Fred Hutchinson Cancer Center	Seattle	Washington
Icon Cancer Centre Southport	Southport	Queensland
Monash Medical Centre	Clayton	Victoria
Universitair Ziekenhuis Antwerpen	Antwerp	Belgium
Universitair Ziekenhuis Leuven - Campus Gasthuisberg	Leuven	Belgium
Centre Hospitalier Universitaire de Liège	Liège	Belgium
Fakultní Nemocnice Hradec Králové	Hradec Králové	Czechia
Fakultní Nemocnice Olomouc	Olomouc	Czechia
Vseobecna Fakultni Nemocnice v Praze	Prague	Czechia
Centre Hospitalier Régional et Universitaire de Besançon - Hôpital Jean-Minjoz	Besançon	France
Centre Hospitalier Universitaire de Bordeaux	Bordeaux	France
Hôpital Morvan	Brest	France
Centre Léon Bérard	Lyon	France
Hôpital Privé Jean Mermoz	Lyon	France
Institut Paoli-Calmettes	Marseille	France
Hôpital Saint-Antoine	Paris	France
Hôpital Trousseau	Paris	France
Hôpital Rangueil	Toulouse	France
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi	Catania	Italy
Azienda Ospedaliero - Universitaria Careggi	Florence	Italy
Fondazione IRCCS - Istituto Nazionale dei Tumori	Milan	Italy
Policlinico Universitario Campus Bio-Medico	Roma	Italy
Azienda Sanitaria Universitaria Friuli Centrale - P.O. Santa Maria della Misericordia	Udine	Italy
National Cancer Center Hospital East	Chiba	Japan
Kyushu Cancer Center	Fukuoka	Japan
Gifu University Hospital	Gifu	Japan
Japanese Red Cross Kumamoto Hospital	Kumamoto	Japan
University Hospital Kyoto Prefectural University of Medicine	Kyoto	Japan
Nagasaki University Hospital	Nagasaki	Japan
Osaka Prefectural Hospital Organization - Osaka International Cancer Institute	Osaka	Japan
Kindai University Hospital	Osaka	Japan
Oita University Hospital - Hasama Campus	Ōita	Japan
Saitama Cancer Center	Saitama	Japan
Tohoku University Hospital	Sendai	Japan
Shizuoka Cancer Center	Shizuoka	Japan
National Cancer Center Hospital	Tokyo	Japan

+ 43 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05002127 on ClinicalTrials.gov ↗ ← All trials in the USA