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

Sponsor
ALX Oncology Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05002127
Collaborator
Eli Lilly and Company (Industry)
450
45
4
78.5
10
0.1

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

Study Type:
Interventional
Anticipated Enrollment :
450 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Masking Description:
Phase 2 is Open Label; Phase 3 is blinded
Primary Purpose:
Treatment
Official Title:
A Phase 2/3 Study of Evorpacept (ALX148) in Patients With Advanced HER2-Overexpressing Gastric/Gastroesophageal Junction Adenocarcinoma (ASPEN-06)
Actual Study Start Date :
Jan 15, 2022
Anticipated Primary Completion Date :
Jul 1, 2026
Anticipated Study Completion Date :
Aug 1, 2028

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:
  • 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
  • Outcome Measures

    Primary Outcome Measures

    1. Phase 2 [Last randomized patient on study at least 16 weeks]

      Percentage of patients with objective response per RECIST 1.1

    2. 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

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.
    Responsible Party:
    ALX Oncology Inc.
    ClinicalTrials.gov Identifier:
    NCT05002127
    Other Study ID Numbers:
    • AT148006
    First Posted:
    Aug 12, 2021
    Last Update Posted:
    Aug 18, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by ALX Oncology Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 18, 2022