A Study of Evorpacept (ALX148) in Patients With Advanced HER2+ Gastric Cancer (ASPEN-06)
- Conditions
- Gastric CancerGastroesophageal Junction AdenocarcinomaGastric Adenocarcinoma
- Interventions
- 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 (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 & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 450
- 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
- Patients with known symptomatic 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 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 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 2 - 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 2 - 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 2 - 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 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 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 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 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 B Paclitaxel 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.
- 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
- Secondary Outcome Measures
Name Time Method
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
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
🇮🇹Milano, 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
Saitama Cancer Center
🇯🇵Saitama, Japan
Tohoku University Hospital
🇯🇵Sendai, Japan
Shizuoka Cancer Center
🇯🇵Shizuoka, Japan
National Cancer Center Hospital
🇯🇵Tokyo, Japan
Cancer Institute Hospital of JFCR
🇯🇵Tokyo, Japan
Kanagawa Cancer Center
🇯🇵Yokohama, Japan
Oita University Hospital - Hasama Campus
🇯🇵Ōita, Japan
Inje University Haeundae Paik Hospital
🇰🇷Busan, Korea, Republic of
Dong-A University 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
Hallym University Sacred Heart Hospital
🇰🇷Dongan, 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
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea Saint Vincent's Hospital
🇰🇷Suwon, Korea, Republic of
National Cancer Centre Singapore
🇸🇬Singapore, Singapore
Icon Cancer Centre Farrer Park
🇸🇬Singapore, Singapore
Hospital General Universitario de Elche
🇪🇸Alicante, Spain
Hospital Germans Trias i Pujol
🇪🇸Badalona, Spain
Hospital Quirónsalud Barcelona
🇪🇸Barcelona, Spain
Hospital Universitari Vall d'Hebrón
🇪🇸Barcelona, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Hospital Universitario Reina Sofía
🇪🇸Córdoba, Spain
Hospital Universitario Lucus Augusti
🇪🇸Lugo, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Spain
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain
Koo Foundation Sun Yat-Sen Cancer Center
🇨🇳Beitou, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
China Medical University Hospital
🇨🇳Taichung, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
Chi Mei Hospital - Liouying
🇨🇳Tainan, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Royal Free Hospital
🇬🇧London, United Kingdom
Guy's and Saint Thomas' NHS Foundation Trust
🇬🇧London, United Kingdom
The Royal Marsden Hospital
🇬🇧London, United Kingdom