A Study of Evorpacept (ALX148) in Patients With Advanced HER2+ Gastric Cancer (ASPEN-06)
- Trial number:
- NCT05002127
- Trial phase:
- 2, 3
- Study type:
- Immunotherapy, Targeted therapy, Chemotherapy
- Overall status:
- Recruiting
Study start date
January, 2022
Scientific title
A Phase 2/3 Study of Evorpacept (ALX148) in Patients With Advanced HER2-Overexpressing Gastric/Gastroesophageal Junction Adenocarcinoma (ASPEN-06)
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.
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
Study design
Primary purpose:
Treatment, Allocation:
Randomized, Intervention model:
Parallel Assignment, Masking:
None (Open Label), Masking description:
Phase 2 is Open Label; Phase 3 is blinded,
Conditions
Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Gastric Adenocarcinoma
Other study ID numbers
AT148006
Choose trial site (57)
The Oncology Institute of Hope & Innovation
1801 W Romneya Dr Suite 103, Anaheim, CA 92801, USA
Vanderbilt University Medical Center
1211 Medical Center Dr, Nashville, TN 37232, USA
NEXT Virginia
Fairfax, VA 22031, USA
Dong-A University Hospital
26 Daesingongwon-ro, Seo-gu, Busan, South Korea
Jeonbuk National University Hospital
20 Geonji-ro, Geumam 2(i)-dong, Deokjin-gu, Jeonju, Jeollabuk-do, South Korea
Seoul National University Bundang Hospital
82 Gumi-ro 173(baekchilsipsam)beo, Bundang-gu, Seongnam-si, Gyeonggi-do, South Korea
Korea University Guro Hospital
148 Gurodong-ro, Guro-dong, Guro-gu, Seoul, South Korea
Samsung Medical Center
81 Irwon-ro, Gangnam-gu, Seoul, South Korea
Seoul National University Hospital
South Korea, Seoul, Jongno-gu, Daehak-ro, 101 서울대학교암병원
Severance Hospital
50-1 Yonsei-ro, Sinchon-dong, Seodaemun-gu, Seoul, South Korea
Hospital General Universitario de Elche
Carrer Almazara, 11, 03203 Elche, Alicante, Spain
Hospital Universitari Vall d'Hebrón
Passeig de la Vall d'Hebron, 119, 08035 Barcelona, Spain
Hospital Universitario Reina Sofía
Av. Menendez Pidal, s/n, 14004 Córdoba, Spain
Hospital Universitario Ramón y Cajal
M-607, 9, 100, 28034 Madrid, Spain
Hospital Universitario Marqués de Valdecilla
Av. de Valdecilla, 25, 39008 Santander, Cantabria, Spain
China Medical University Hospital
No. 2, Yude Rd, North District, Taichung City, Taiwan 404
National Cancer Centre Singapore
Farrer Park
University of California Los Angeles
Los Angeles, CA 90095, USA
Fred Hutchinson Cancer Center
Seattle, WA 98109, USA
Universitair Ziekenhuis Antwerpen
Drie Eikenstraat 655, 2650 Edegem, Belgium
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Herestraat 49, 3000 Leuven, Belgium
Fakultní Nemocnice Hradec Králové
Sokolská 581, Nový Hradec Králové, 500 05 Hradec Králové, Czechia
Fakultní nemocnice Olomouc
I.P. Pavlova 185/6, 779 00 Olomouc, Czechia
Centre Hospitalier Régional et Universitaire de Besançon - Hôpital Jean-Minjoz
3 Bd Alexandre Fleming, 25000 Besançon, France
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, France
Centre Léon Bérard
28 Prom. Léa et Napoléon Bullukian, 69008 Lyon, France
Hôpital Saint-Antoine
184 Rue du Faubourg Saint-Antoine, 75012 Paris, France
Hôpital Trousseau
26 Av. du Dr Arnold Netter, 75012 Paris, France
Hôpital Rangueil
1 Av. du Professeur Jean Poulhès, 31400 Toulouse, France
Azienda Ospedaliero - Universitaria Careggi
Largo Giovanni Alessandro Brambilla, 3, 50134 Firenze FI, Italy
Fondazione IRCCS - Istituto Nazionale dei Tumori
Via Giacomo Venezian, 1, 20133 Milano MI, Italy
Azienda Sanitaria Universitaria Friuli Centrale - P.O. Santa Maria della Misericordia
Via Pozzuolo, 330, 33100 Udine UD, Italy
National Cancer Center Hospital
5-chōme-1-1 Tsukiji, Chuo City, Tokyo 104-0045, Japan
Inje University Haeundae Paik Hospital
875 Haeun-daero, Haeundae, Busan, South Korea
Yeungnam University Medical Center
Daemyeong-dong, Daegu, South Korea
National Cancer Center - Korea
323 Ilsan-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do, South Korea
Asan Medical Center
88 Olympic-ro 43-gil, Songpa-gu, Seoul, South Korea
Gangnam Severance Hospital
211 Eonju-ro, Gangnam-gu, Seoul, South Korea
Korea University Anam Hospital
South Korea, Seoul, Seongbuk-gu, 고려대로 73
The Catholic University of Korea Saint Vincent's Hospital
93 Jungbu-daero, Paldal-gu, Suwon, Gyeonggi-do, South Korea
Icon Cancer Centre Farrer Park
1 Farrer Park Station Rd, Singapore 217562
National Cancer Centre Singapore
11 Hospital Cres, Singapore 169610
National Cheng Kung University Hospital
No. 138號, Shengli Rd, North District, Tainan City, Taiwan 704
National Taiwan University Hospital
No. 7號, Zhongshan S Rd, Zhongzheng District, Taipei City, Taiwan 100
Taipei Veterans General Hospital
No. 201, Section 2, Shipai Rd, Beitou District, Taipei City, Taiwan 112
Guy's and Saint Thomas' NHS Foundation Trust
London, UK
Centre Hospitalier Universitaire de Liège
Avenue de l'Hôpital 1, 4000 Luik, Belgium
Vseobecna Fakultni Nemocnice v Praze
Hradec Kralove, Czechia
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi
Catania, Metropolitan city of Catania, Italy
Policlinico Universitario Campus Bio-Medico
Via Álvaro del Portillo, 200, 00128 Roma RM, Italy
Pusan National University Hospital
179 Gudeok-ro, Seo-gu, Busan, South Korea
Chungnam National University Hospital
282 Munhwa-ro, Jung-gu, Daejeon, South Korea
Boramae Medical Center
South Korea, Seoul, 보라매병원
Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine
25-2 Seonggyungwan-ro, Jongno-gu, Seoul, South Korea
Royal Free Hospital
Pond St, London NW3 2QG, UK
The Royal Marsden Hospital
203 Fulham Rd., London SW3 6JJ, UK