A Study of Evorpacept (ALX148) in Patients With Advanced HER2+ Gastric Cancer (ASPEN-06)
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2/Phase 3 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Phase 2 - Arm A 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. |
Drug: Evorpacept (ALX148)
IV Q2W
Drug: Trastuzumab
IV Q2W
Other Names:
Drug: Ramucirumab
IV Q2W
Other Names:
Drug: Paclitaxel
IV Days 1, 8, and 15 of a 28-day cycle
Other Names:
|
Active Comparator: Phase 2 - Arm B 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. |
Drug: Trastuzumab
IV Q2W
Other Names:
Drug: Ramucirumab
IV Q2W
Other Names:
Drug: Paclitaxel
IV Days 1, 8, and 15 of a 28-day cycle
Other Names:
|
Experimental: Phase 3 - Arm A 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. |
Drug: Evorpacept (ALX148)
IV Q2W
Drug: Trastuzumab
IV Q2W
Other Names:
Drug: Ramucirumab
IV Q2W
Other Names:
Drug: Paclitaxel
IV Days 1, 8, and 15 of a 28-day cycle
Other Names:
|
Active Comparator: Phase 3 - Arm B Ramucirumab 8 mg/kg Q2W IV and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle. |
Drug: Ramucirumab
IV Q2W
Other Names:
Drug: Paclitaxel
IV Days 1, 8, and 15 of a 28-day cycle
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
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 CNS metastases or leptomeningeal disease requiring steroids.
-
Prior treatment with any anti-CD47 or anti-SIRPα agent.
-
Prior treatment with ramucirumab.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | The Oncology Institute of Hope & Innovation | Anaheim | California | United States | 92801 |
2 | University of California Los Angeles | Los Angeles | California | United States | 90095 |
3 | Vanderbilt University Medical Center | Nashville | Tennessee | United States | 37232 |
4 | NEXT Virginia | Fairfax | Virginia | United States | 22031 |
5 | Fred Hutchinson Cancer Center | Seattle | Washington | United States | 98109 |
6 | Universitair Ziekenhuis Antwerpen | Antwerp | Belgium | ||
7 | Universitair Ziekenhuis Leuven - Campus Gasthuisberg | Leuven | Belgium | ||
8 | Fakultní Nemocnice Hradec Králové | Hradec Králové | Czechia | ||
9 | Fakultní nemocnice Olomouc | Olomouc | Czechia | ||
10 | Centre Hospitalier Régional et Universitaire de Besançon - Hôpital Jean-Minjoz | Besançon | France | ||
11 | Centre Hospitalier Universitaire de Bordeaux | Bordeaux | France | ||
12 | Centre Léon Bérard | Lyon | France | ||
13 | Hôpital Saint-Antoine | Paris | France | ||
14 | Hôpital Trousseau | Paris | France | ||
15 | Hôpital Rangueil | Toulouse | France | ||
16 | Azienda Ospedaliero - Universitaria Careggi | Florence | Italy | ||
17 | Fondazione IRCCS - Istituto Nazionale dei Tumori | Milano | Italy | ||
18 | Azienda Sanitaria Universitaria Friuli Centrale - P.O. Santa Maria della Misericordia | Udine | Italy | ||
19 | National Cancer Center Hospital | Tokyo | Japan | ||
20 | Dong-A University Hospital | Busan | Korea, Republic of | ||
21 | Inje University Haeundae Paik Hospital | Busan | Korea, Republic of | ||
22 | Yeungnam University Medical Center | Daegu | Korea, Republic of | ||
23 | National Cancer Center - Korea | Goyang-si | Korea, Republic of | ||
24 | Jeonbuk National University Hospital | Jeonju | Korea, Republic of | ||
25 | Seoul National University Bundang Hospital | Seongnam | Korea, Republic of | ||
26 | Asan Medical Center | Seoul | Korea, Republic of | ||
27 | Gangnam Severance Hospital | Seoul | Korea, Republic of | ||
28 | Korea University Anam Hospital | Seoul | Korea, Republic of | ||
29 | Korea University Guro Hospital | Seoul | Korea, Republic of | ||
30 | Samsung Medical Center | Seoul | Korea, Republic of | ||
31 | Seoul National University Hospital | Seoul | Korea, Republic of | ||
32 | Severance Hospital | Seoul | Korea, Republic of | ||
33 | The Catholic University of Korea Saint Vincent's Hospital | Suwon | Korea, Republic of | ||
34 | Icon Cancer Centre Farrer Park | Singapore | Singapore | ||
35 | National Cancer Centre Singapore | Singapore | Singapore | ||
36 | Hospital General Universitario de Elche | Alicante | Spain | ||
37 | Hospital Universitari Vall d'Hebrón | Barcelona | Spain | ||
38 | Hospital Universitario Reina Sofía | Córdoba | Spain | ||
39 | Hospital Universitario Ramón y Cajal | Madrid | Spain | ||
40 | Hospital Universitario Marqués de Valdecilla | Santander | Spain | ||
41 | China Medical University Hospital | Taichung | Taiwan | ||
42 | National Cheng Kung University Hospital | Tainan | Taiwan | ||
43 | National Taiwan University Hospital | Taipei | Taiwan | ||
44 | Taipei Veterans General Hospital | Taipei | Taiwan | ||
45 | Guy's and Saint Thomas' NHS Foundation Trust | London | United Kingdom |
Sponsors and Collaborators
- ALX Oncology Inc.
- Eli Lilly and Company
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AT148006