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

NCT05002127 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: AT148006
• Study Type: interventional
• Target: 127
• Locations: 12 countries
• Sites: 83

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.

Conditions

Gastric Cancer; Gastroesophageal Junction Adenocarcinoma; Gastric Adenocarcinoma

Keywords

ALX148; CD47; SIRPα; Gastric; Gastroesophageal; GEJ; HER2 positive; Ramucirumab; Evorpacept

Outcome Measures

Primary Outcomes (2)

• Phase 2

  Percentage of patients with objective response per RECIST 1.1

  Last randomized patient on study at least 16 weeks

• Phase 3

  Overall Survival

  From the date of randomization to the date of death (due to any cause), up to 36 months postdose

Study Arms (4)

Phase 2 - Arm A

EXPERIMENTAL

Evorpacept (ALX148) 30 mg/kg every two weeks (Q2W) intravenous (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); Drug: Trastuzumab; Drug: Ramucirumab; Drug: Paclitaxel

Phase 2 - Arm B

ACTIVE COMPARATOR

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; Drug: Ramucirumab; Drug: Paclitaxel

Phase 3 - Arm A

EXPERIMENTAL

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); Drug: Trastuzumab; Drug: Ramucirumab; Drug: Paclitaxel

Phase 3 - Arm B

ACTIVE COMPARATOR

Ramucirumab 8 mg/kg Q2W IV and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle.

Drug: Ramucirumab; Drug: Paclitaxel

Interventions

Evorpacept (ALX148) DRUG

IV Q2W

Phase 2 - Arm A; Phase 3 - Arm A

Trastuzumab DRUG

IV Q2W

Also known as: Herceptin

Phase 2 - Arm A; Phase 2 - Arm B; Phase 3 - Arm A

Ramucirumab DRUG

IV Q2W

Also known as: Cyramza

Phase 2 - Arm A; Phase 2 - Arm B; Phase 3 - Arm A; Phase 3 - Arm B

Paclitaxel DRUG

IV Days 1, 8, and 15 of a 28-day cycle

Also known as: Taxol

Phase 2 - Arm A; Phase 2 - Arm B; Phase 3 - Arm A; Phase 3 - Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• ALX Oncology Inc.: lead
• Eli Lilly and Company: collaborator

Study Sites (83)

The Oncology Institute of Hope & Innovation

Anaheim, California, 92801, United States

Location

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

NEXT Virginia

Fairfax, Virginia, 22031, United States

Location

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

Location

Icon Cancer Centre Southport

Southport, Queensland, 4215, Australia

Location

Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

Universitair Ziekenhuis Antwerpen

Antwerp, 2650, Belgium

Location

Universitair Ziekenhuis Leuven - Campus Gasthuisberg

Leuven, 3000, Belgium

Location

Centre Hospitalier Universitaire de Liège

Liège, 4000, Belgium

Location

Fakultní Nemocnice Hradec Králové

Hradec Králové, 500 05, Czechia

Location

Fakultní Nemocnice Olomouc

Olomouc, 779 00, Czechia

Location

Vseobecna Fakultni Nemocnice v Praze

Prague, 12800, Czechia

Location

Centre Hospitalier Régional et Universitaire de Besançon - Hôpital Jean-Minjoz

Besançon, 25030, France

Location

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, 33000, France

Location

Hôpital Morvan

Brest, 29200, France

Location

Centre Léon Bérard

Lyon, 69008, France

Location

Hôpital Privé Jean Mermoz

Lyon, 69008, France

Location

Institut Paoli-Calmettes

Marseille, 13009, France

Location

Hôpital Saint-Antoine

Paris, 75012, France

Location

Hôpital Trousseau

Paris, 75012, France

Location

Hôpital Rangueil

Toulouse, 31059, France

Location

Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi

Catania, 95123, Italy

Location

Azienda Ospedaliero - Universitaria Careggi

Florence, 50134, Italy

Location

Fondazione IRCCS - Istituto Nazionale dei Tumori

Milan, 20133, Italy

Location

Policlinico Universitario Campus Bio-Medico

Roma, 00128, Italy

Location

Azienda Sanitaria Universitaria Friuli Centrale - P.O. Santa Maria della Misericordia

Udine, 33100, Italy

Location

National Cancer Center Hospital East

Chiba, 277-8577, Japan

Location

Kyushu Cancer Center

Fukuoka, 811-1395, Japan

Location

Gifu University Hospital

Gifu, 501-1194, Japan

Location

Japanese Red Cross Kumamoto Hospital

Kumamoto, 861-8520, Japan

Location

University Hospital Kyoto Prefectural University of Medicine

Kyoto, 602-8566, Japan

Location

Nagasaki University Hospital

Nagasaki, 852-8501, Japan

Location

Osaka Prefectural Hospital Organization - Osaka International Cancer Institute

Osaka, 541-8567, Japan

Location

Kindai University Hospital

Osaka, 589-8511, Japan

Location

Oita University Hospital - Hasama Campus

Ōita, 879-5593, Japan

Location

Saitama Cancer Center

Saitama, 362-0806, Japan

Location

Tohoku University Hospital

Sendai, 980-8574, Japan

Location

Shizuoka Cancer Center

Shizuoka, 411-8777, Japan

Location

National Cancer Center Hospital

Tokyo, 104-0045, Japan

Location

Cancer Institute Hospital of JFCR

Tokyo, 135-8550, Japan

Location

Kanagawa Cancer Center

Yokohama, 241-8515, Japan

Location

National Cancer Centre Singapore

Singapore, 168583, Singapore

Location

Icon Cancer Centre Farrer Park

Singapore, 217562, Singapore

Location

Inje University Haeundae Paik Hospital

Busan, 48108, South Korea

Location

Dong-A University Hospital

Busan, 49201, South Korea

Location

Pusan National University Hospital

Busan, 49241, South Korea

Location

Yeungnam University Medical Center

Daegu, 42415, South Korea

Location

Chungnam National University Hospital

Daejeon, 35015, South Korea

Location

Hallym University Sacred Heart Hospital

Dongan, 14068, South Korea

Location

National Cancer Center - Korea

Goyang-si, 10408, South Korea

Location

Jeonbuk National University Hospital

Jeonju, 561-712, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, 13620, South Korea

Location

Korea University Anam Hospital

Seoul, 02708, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine

Seoul, 03181, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Gangnam Severance Hospital

Seoul, 06273, South Korea

Location

Severance Hospital

Seoul, 06273, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Boramae Medical Center

Seoul, 07061, South Korea

Location

Korea University Guro Hospital

Seoul, 10408, South Korea

Location

The Catholic University of Korea Saint Vincent's Hospital

Suwon, 16247, South Korea

Location

Hospital General Universitario de Elche

Alicante, 03203, Spain

Location

Hospital Germans Trias i Pujol

Badalona, 08916, Spain

Location

Hospital Quirónsalud Barcelona

Barcelona, 08035, Spain

Location

Hospital Universitari Vall d'Hebrón

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario Reina Sofía

Córdoba, 14004, Spain

Location

Hospital Universitario Lucus Augusti

Lugo, 27003, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, 39008, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Koo Foundation Sun Yat-Sen Cancer Center

Beitou, 112, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

Chi Mei Hospital - Liouying

Tainan, 73657, Taiwan

Location

National Taiwan University Hospital

Taipei, 10048, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

Guy's and Saint Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom

Location

The Royal Marsden Hospital

London, SW3 6JJ, United Kingdom

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

ALX148; Trastuzumab; Ramucirumab; Paclitaxel

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Phase 2 is Open Label; Phase 3 is blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 12, 2021
• Study Start: January 15, 2022
• Primary Completion: May 24, 2024
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (19); BE (3); CZ (3); GB (3); US (5); AU (2); FR (9); JP (15); IT (5); SG (2); ES (10); TW (7)