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NCT05002127 Clinical Trial

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

Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05002127
Other study ID # AT148006
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date January 15, 2022
Est. completion date August 2028

Study information
Verified date January 2023
Source ALX Oncology Inc.
Contact Philip Fanning, PhD
Phone 650-466-7125
Email info@alxoncology.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 450
Est. completion date August 2028
Est. primary completion date July 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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-SIRPa agent. - Prior treatment with ramucirumab.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Evorpacept (ALX148)
IV Q2W
• Trastuzumab
IV Q2W
• Ramucirumab
IV Q2W
• Paclitaxel
IV Days 1, 8, and 15 of a 28-day cycle

Locations
Country Name City State
Belgium Universitair Ziekenhuis Antwerpen Antwerp
Belgium Universitair Ziekenhuis Leuven - Campus Gasthuisberg Leuven
Belgium Centre Hospitalier Universitaire de Liège Liège
Czechia Vseobecna Fakultni Nemocnice v Praze Hradec Kralove
Czechia Fakultní Nemocnice Hradec Králové Hradec Králové
Czechia Fakultní nemocnice Olomouc Olomouc
France Centre Hospitalier Régional et Universitaire de Besançon - Hôpital Jean-Minjoz Besançon
France Centre Hospitalier Universitaire de Bordeaux Bordeaux
France Centre Léon Bérard Lyon
France Hôpital Saint-Antoine Paris
France Hôpital Trousseau Paris
France Hôpital Rangueil Toulouse
Italy Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi Catania
Italy Azienda Ospedaliero - Universitaria Careggi Florence
Italy Fondazione IRCCS - Istituto Nazionale dei Tumori Milano
Italy Policlinico Universitario Campus Bio-Medico Roma
Italy Azienda Sanitaria Universitaria Friuli Centrale - P.O. Santa Maria della Misericordia Udine
Japan National Cancer Center Hospital Tokyo
Korea, Republic of Dong-A University Hospital Busan
Korea, Republic of Inje University Haeundae Paik Hospital Busan
Korea, Republic of Pusan National University Hospital Busan
Korea, Republic of Yeungnam University Medical Center Daegu
Korea, Republic of Chungnam National University Hospital Daejeon
Korea, Republic of National Cancer Center - Korea Goyang-si
Korea, Republic of Jeonbuk National University Hospital Jeonju
Korea, Republic of Seoul National University Bundang Hospital Seongnam
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Boramae Medical Center Seoul
Korea, Republic of Gangnam Severance Hospital Seoul
Korea, Republic of Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine Seoul
Korea, Republic of Korea University Anam Hospital Seoul
Korea, Republic of Korea University Guro Hospital Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Severance Hospital Seoul
Korea, Republic of The Catholic University of Korea Saint Vincent's Hospital Suwon
Singapore Icon Cancer Centre Farrer Park Singapore
Singapore National Cancer Centre Singapore Singapore
Spain Hospital General Universitario de Elche Alicante
Spain Hospital Universitari Vall d'Hebrón Barcelona
Spain Hospital Universitario Reina Sofía Córdoba
Spain Hospital Universitario Ramón y Cajal Madrid
Spain Hospital Universitario Marqués de Valdecilla Santander
Taiwan China Medical University Hospital Taichung
Taiwan National Cheng Kung University Hospital Tainan
Taiwan National Taiwan University Hospital Taipei
Taiwan Taipei Veterans General Hospital Taipei
United Kingdom Guy's and Saint Thomas' NHS Foundation Trust London
United Kingdom Royal Free Hospital London
United Kingdom The Royal Marsden Hospital London
United States The Oncology Institute of Hope & Innovation Anaheim California
United States NEXT Virginia Fairfax Virginia
United States University of California Los Angeles Los Angeles California
United States Vanderbilt University Medical Center Nashville Tennessee
United States Fred Hutchinson Cancer Center Seattle Washington

Sponsors (2)
Lead Sponsor Collaborator
ALX Oncology Inc. Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Belgium,  Czechia,  France,  Italy,  Japan,  Korea, Republic of,  Singapore,  Spain,  Taiwan,  United Kingdom, 

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