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

January 23, 2023 updated by: ALX Oncology Inc.

A Phase 2/3 Study of Evorpacept (ALX148) in Patients With Advanced HER2-Overexpressing Gastric/Gastroesophageal Junction Adenocarcinoma (ASPEN-06)

A Phase 2/3 Study of Evorpacept (ALX148) in Combination With Trastuzumab, Ramucirumab, and Paclitaxel in Patients With Advanced HER2-overexpressing gastric/GEJ adenocarcinoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

450

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Antwerp, Belgium
        • Recruiting
        • Universitair Ziekenhuis Antwerpen
      • Leuven, Belgium
        • Recruiting
        • Universitair Ziekenhuis Leuven - Campus Gasthuisberg
      • Liège, Belgium
        • Recruiting
        • Centre hospitalier universitaire de Liege
  • Czechia
      • Hradec Kralove, Czechia
        • Recruiting
        • Vseobecna fakultni nemocnice v Praze
      • Hradec Králové, Czechia
        • Recruiting
        • Fakultni nemocnice Hradec Kralove
      • Olomouc, Czechia
        • Recruiting
        • Fakultni Nemocnice Olomouc
  • France
      • Besançon, France
        • Recruiting
        • Centre Hospitalier Regional et Universitaire de Besancon - Hopital Jean-Minjoz
      • Bordeaux, France
        • Recruiting
        • Centre hospitalier Universitaire de Bordeaux
      • Lyon, France
        • Recruiting
        • Centre Léon Bérard
      • Paris, France
        • Recruiting
        • Hopital Saint-Antoine
      • Paris, France
        • Recruiting
        • Hôpital Trousseau
      • Toulouse, France
        • Recruiting
        • Hôpital Rangueil
  • Italy
      • Catania, Italy
        • Recruiting
        • Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi
      • Florence, Italy
        • Recruiting
        • Azienda Ospedaliero - Universitaria Careggi
      • Milano, Italy
        • Recruiting
        • Fondazione IRCCS - Istituto Nazionale dei Tumori
      • Roma, Italy
        • Recruiting
        • Policlinico Universitario Campus Bio-Medico
      • Udine, Italy
        • Recruiting
        • Azienda Sanitaria Universitaria Friuli Centrale - P.O. Santa Maria della Misericordia
  • Japan
      • Tokyo, Japan
        • Recruiting
        • National Cancer Center Hospital
  • Korea, Republic of
      • Busan, Korea, Republic of
        • Recruiting
        • Pusan National University Hospital
      • Busan, Korea, Republic of
        • Recruiting
        • Dong-A University Hospital
      • Busan, Korea, Republic of
        • Recruiting
        • Inje University Haeundae Paik Hospital
      • Daegu, Korea, Republic of
        • Recruiting
        • Yeungnam University Medical Center
      • Daejeon, Korea, Republic of
        • Recruiting
        • Chungnam National University Hospital
      • Goyang-si, Korea, Republic of
        • Recruiting
        • National Cancer Center - Korea
      • Jeonju, Korea, Republic of
        • Recruiting
        • Jeonbuk National University Hospital
      • Seongnam, Korea, Republic of
        • Recruiting
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Asan Medical Center
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Gangnam Severance Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Severance Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Samsung Medical Center
      • Seoul, Korea, Republic of
        • Recruiting
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine
      • Seoul, Korea, Republic of
        • Recruiting
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Boramae Medical Center
      • Suwon, Korea, Republic of
        • Recruiting
        • The Catholic University of Korea Saint Vincent's Hospital
  • Singapore
      • Singapore, Singapore
        • Recruiting
        • National Cancer Centre Singapore
      • Singapore, Singapore
        • Recruiting
        • Icon Cancer Centre Farrer Park
  • Spain
      • Alicante, Spain
        • Recruiting
        • Hospital General Universitario de Elche
      • Barcelona, Spain
        • Recruiting
        • Hospital Universitari Vall d'Hebron
      • Córdoba, Spain
        • Recruiting
        • Hospital Universitario Reina Sofia
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Ramon y Cajal
      • Santander, Spain
        • Recruiting
        • Hospital Universitario Marques de Valdecilla
  • Taiwan
      • Taichung, Taiwan
        • Recruiting
        • China Medical University Hospital
      • Tainan, Taiwan
        • Recruiting
        • National Cheng Kung University Hospital
      • Taipei, Taiwan
        • Recruiting
        • Taipei Veterans General Hospital
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
  • United Kingdom
      • London, United Kingdom
        • Recruiting
        • Royal Free Hospital
      • London, United Kingdom
        • Recruiting
        • Guy's and Saint Thomas' NHS Foundation Trust
      • London, United Kingdom
        • Recruiting
        • The Royal Marsden Hospital
  • United States
    • California
      • Anaheim, California, United States, 92801
        • Recruiting
        • The Oncology Institute of Hope & Innovation
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California Los Angeles
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • NEXT Virginia
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • Herceptin
Drug: Ramucirumab
IV Q2W
Other Names:
  • Cyramza
Drug: Paclitaxel
IV Days 1, 8, and 15 of a 28-day cycle
Other Names:
  • Taxol
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:
  • Herceptin
Drug: Ramucirumab
IV Q2W
Other Names:
  • Cyramza
Drug: Paclitaxel
IV Days 1, 8, and 15 of a 28-day cycle
Other Names:
  • Taxol
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:
  • Herceptin
Drug: Ramucirumab
IV Q2W
Other Names:
  • Cyramza
Drug: Paclitaxel
IV Days 1, 8, and 15 of a 28-day cycle
Other Names:
  • Taxol
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:
  • Cyramza
Drug: Paclitaxel
IV Days 1, 8, and 15 of a 28-day cycle
Other Names:
  • Taxol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 2
Time Frame: Last randomized patient on study at least 16 weeks
Percentage of patients with objective response per RECIST 1.1
Last randomized patient on study at least 16 weeks
Phase 3
Time Frame: From the date of randomization to the date of death (due to any cause), up to 36 months postdose
Overall Survival
From the date of randomization to the date of death (due to any cause), up to 36 months postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ALX Oncology Inc.

Collaborators

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2022

Primary Completion (Anticipated)

July 1, 2026

Study Completion (Anticipated)

August 1, 2028

Study Registration Dates

First Submitted

July 27, 2021

First Submitted That Met QC Criteria

August 4, 2021

First Posted (Actual)

August 12, 2021

Study Record Updates

Last Update Posted (Estimate)

January 24, 2023

Last Update Submitted That Met QC Criteria

January 23, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AT148006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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