Clinical trial NCT05002127: A Study of Evorpacept (ALX148) in Patients With Advanced HER2+ Gastric Cancer (ASPEN-06)
Official title: A Phase 2/3 Study of Evorpacept (ALX148) in Patients With Advanced HER2-Overexpressing Gastric/Gastroesophageal Junction Adenocarcinoma (ASPEN-06)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Gastric Cancer
Gastroesophageal Junction Adenocarcinoma
Gastric Adenocarcinoma
Keywords: ALX148
CD47
SIRPα
Gastric
Gastroesophageal
GEJ
HER2 positive
Ramucirumab
Evorpacept
Lead sponsor: ALX Oncology Inc.
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2021-08-12
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 outcomes:
measure: Phase 2
timeFrame: Last randomized patient on study at least 16 weeks
measure: Phase 3
timeFrame: From the date of randomization to the date of death (due to any cause), up to 36 months postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: The Oncology Institute of Hope & Innovation
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Fairfax
country: United States
facility: NEXT Virginia
state: Virginia
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center
state: Washington
city: Southport
country: Australia
facility: Icon Cancer Centre Southport
state: Queensland
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Antwerp
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire de Liège
city: Hradec Králové
country: Czechia
facility: Fakultní Nemocnice Hradec Králové
city: Olomouc
country: Czechia
facility: Fakultní Nemocnice Olomouc
city: Prague
country: Czechia
facility: Vseobecna Fakultni Nemocnice v Praze
city: Besançon
country: France
facility: Centre Hospitalier Régional et Universitaire de Besançon - Hôpital Jean-Minjoz
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire de Bordeaux
city: Brest
country: France
facility: Hôpital Morvan
city: Lyon
country: France
facility: Centre Léon Bérard
city: Lyon
country: France
facility: Hôpital Privé Jean Mermoz
city: Marseille
country: France
facility: Institut Paoli-Calmettes
city: Paris
country: France
facility: Hôpital Saint-Antoine
city: Paris
country: France
facility: Hôpital Trousseau
city: Toulouse
country: France
facility: Hôpital Rangueil
city: Catania
country: Italy
facility: Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi
city: Florence
country: Italy
facility: Azienda Ospedaliero - Universitaria Careggi
city: Milano
country: Italy
facility: Fondazione IRCCS - Istituto Nazionale dei Tumori
city: Roma
country: Italy
facility: Policlinico Universitario Campus Bio-Medico
city: Udine
country: Italy
facility: Azienda Sanitaria Universitaria Friuli Centrale - P.O. Santa Maria della Misericordia
city: Chiba
country: Japan
facility: National Cancer Center Hospital East
city: Fukuoka
country: Japan
facility: Kyushu Cancer Center
city: Gifu
country: Japan
facility: Gifu University Hospital
city: Kumamoto
country: Japan
facility: Japanese Red Cross Kumamoto Hospital
city: Kyoto
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital
city: Osaka
country: Japan
facility: Osaka Prefectural Hospital Organization - Osaka International Cancer Institute
city: Osaka
country: Japan
facility: Kindai University Hospital
city: Saitama
country: Japan
facility: Saitama Cancer Center
city: Sendai
country: Japan
facility: Tohoku University Hospital
city: Shizuoka
country: Japan
facility: Shizuoka Cancer Center
city: Tokyo
country: Japan
facility: National Cancer Center Hospital
city: Tokyo
country: Japan
facility: Cancer Institute Hospital of JFCR
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center
city: Ōita
country: Japan
facility: Oita University Hospital - Hasama Campus
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Dongan
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center - Korea
city: Jeonju
country: Korea, Republic of
facility: Jeonbuk National University Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Suwon
country: Korea, Republic of
facility: The Catholic University of Korea Saint Vincent's Hospital
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
city: Singapore
country: Singapore
facility: Icon Cancer Centre Farrer Park
city: Alicante
country: Spain
facility: Hospital General Universitario de Elche
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Quirónsalud Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebrón
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Beitou
country: Taiwan
facility: Koo Foundation Sun Yat-Sen Cancer Center
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Tainan
country: Taiwan
facility: Chi Mei Hospital - Liouying
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: Guy's and Saint Thomas' NHS Foundation Trust
city: London
country: United Kingdom
facility: The Royal Marsden Hospital
Study officials:
References: