TrialPath
Recruiting

ASPEN-09-03: A Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Metastatic HER2-Positive Breast Cancer

NCT07007559 · ALX Oncology Inc.
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Official title
Protocol ASPEN-09-03: A Single-arm Phase 2 Multicenter Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Participants With Metastatic HER2-Positive Breast Cancer, a Substudy Under Master Protocol ASPEN-09: A Phase 1b/2, Multicenter, Multi Arm Study of Evorpacept in Combination With Anti-cancer Therapies in Advanced / Metastatic Malignancies
About this study
Participants will continue study treatment until disease progression, death, unacceptable toxicity, participant request to stop treatment, investigator decision or study termination by the sponsor. As ASPEN-09-03 (MBC) is the only substudy open under ASPEN-09, the information reflected in the enrollment number, arms/interventions, outcome measures, and eligibility criteria currently includes only MBC.
Eligibility criteria
Inclusion Criteria: * Histologically confirmed invasive HER2+ breast cancer based on an evaluable tumor tissue biopsy obtained after cessation of T-DXd (ENHERTU) treatment and no more than 6 months prior to C1D1. * Received no more than 4 prior lines of HER2-directed therapy including at least one prior line of T-DXd (ENHERTU) for locally advanced/metastatic HER2+ breast cancer. Prior neoadjuvant therapy which resulted in relapse within 6 months of completion of T-DXd will be considered a line of treatment for metastatic disease. Participants who discontinue T-DXd due to intolerance are considered eligible. * Progressed on or following the most recent line of therapy. * Eligible to receive one of the following chemotherapy options (capecitabine, eribulin, gemcitabine, paclitaxel or vinorelbine). * Measurable disease as defined by RECIST v1.1. * LVEF ≥50%. * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) must be 0 to 1. * Life expectancy of at least 3 months. * Adequate renal function (estimated creatinine clearance ≥30 mL/min as calculated using the Cockcroft-Gault equation or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. * Adequate liver function: * Total bilirubin ≤1.5 x upper limit of normal (ULN) (≤3.0 x ULN if the participant has documented Gilbert syndrome); * Aspartate and alanine transaminase (AST and ALT) ≤3 x ULN (≤5.0 x ULN if liver involved by metastatic disease). * Participants must have recovered from all AEs due to previous therapies, procedures, and surgeries to baseline severity or ≤Grade 1 per NCI CTCAE v5.0 except for AEs not deemed reversible and which do not constitute a safety risk by Investigator judgment. Exclusion Criteria: * Untreated CNS metastases. * Prior exposure to any anti-CD47 or anti-SIRPα agent. * Any condition that would be contraindicated to receiving trastuzumab * Has a diagnosis of complete dihydropyrimidine dehydrogenase (DPD) deficiency or significant toxicity with prior flurouracil (5FU) based regimen * Following anti-cancer therapy with insufficient washout before start of treatment: 1. chemotherapy, hormonal therapy, radiation therapy or small molecule anti-cancer therapy within 14 days or 5 half-lives (whichever is shorter) of start of treatment. 2. Immune therapy or other biologic therapy (e.g., monoclonal antibodies, antibody-drug conjugates) for the treatment of cancer for: 28 days or 5 half-lives (whichever is shorter) of start of treatment). * History of autoimmune hemolytic anemia, autoimmune thrombocytopenia, or hemolytic transfusion reaction. * Had an allogeneic tissue/solid organ transplant. * Any active, unstable cardiovascular disease. * Intolerance to or who have had a severe allergic or anaphylactic reaction to antibodies or infused therapeutic proteins or participants who have had a severe allergic or anaphylactic reaction to any of the substances included in the study drug (including excipients). * Has an active autoimmune disease that has required systemic treatment in past 2 years. * Other primary malignancy within 2 years.
Study design
Enrollment target: 120 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-12-10
Estimated completion: 2028-12
Last updated: 2026-08-14
Interventions
Drug: Evorpacept (ALX148)Drug: TrastuzumabDrug: PaclitaxelDrug: CapecitabineDrug: EribulinDrug: GemcitabineDrug: Vinorelbine
Primary outcomes
  • Overall Response Rate (ORR) using RECIST v1.1 based on BICR assessment (Approximately 6 months after the last participant is enrolled)
Sponsor
ALX Oncology Inc. · industry
Contacts & investigators
ContactCheng Quah, MD · contact · info@alxoncology.com · 650-466-7125
All locations (54)
The University of Arizona Cancer Center - North CampusRecruiting
Tucson, Arizona, United States
City of HopeRecruiting
Duarte, California, United States
UC San Diego Moores Cancer CenterRecruiting
La Jolla, California, United States
UC Irvine Health - Chao Family Comprehensive Cancer CenterRecruiting
Orange, California, United States
Saint Joseph Hospital - Cancer Centers of ColoradoRecruiting
Denver, Colorado, United States
Lutheran Hospital - Cancer Centers of ColoradoRecruiting
Golden, Colorado, United States
Saint Mary's Regional Hospital - Cancer Centers of ColoradoRecruiting
Grand Junction, Colorado, United States
The George Washington Medical facility AssociatesRecruiting
Washington D.C., District of Columbia, United States
Sylvester Comprehensive Cancer CenterRecruiting
Miami, Florida, United States
City of Hope ChicagoRecruiting
Zion, Illinois, United States
University of Michigan Rogel Cancer CenterRecruiting
Ann Arbor, Michigan, United States
HealthPartners Frauenshuh Cancer CenterRecruiting
Saint Louis Park, Minnesota, United States
Washington University School of Medicine- Siteman Cancer CenterRecruiting
St Louis, Missouri, United States
St. Vincent Regional Hospital - Cancer Centers of MontanaRecruiting
Billings, Montana, United States
Oncology Hematology West, Pc Dba Nebraska Cancer SpecialistsRecruiting
Omaha, Nebraska, United States
Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
Gabrail Cancer CenterRecruiting
Canton, Ohio, United States
Oregon Health and Science UniversityRecruiting
Portland, Oregon, United States
University of Texas Southwestern Medical CenterRecruiting
Dallas, Texas, United States
Houston Methodist Cancer CenterRecruiting
Houston, Texas, United States
The University of Texas M.D. Anderson Cancer CenterRecruiting
Houston, Texas, United States
Virginia Cancer SpecialistsRecruiting
Fairfax, Virginia, United States
Fred Hutchinson Cancer CenterRecruiting
Seattle, Washington, United States
University Health Network, Princess Margaret Cancer CentreRecruiting
Toronto, Ontario, Canada
CHU de BesanconRecruiting
Besançon, France
Hopital de l'Institut CurieRecruiting
Paris, France
Hopital Europeen Georges Pompidou (HEGP)Recruiting
Paris, France
Centre Hospitalier Universitaire (CHU) de PoitiersRecruiting
Poitiers, France
Centre Eugene MarquisRecruiting
Rennes, France
Azienda Ospedaliero Universitaria delle MarcheRecruiting
Torrette, AN, Italy
IRCCS Azienda Ospedaliera MetropolitanaRecruiting
Genova, GE, Italy
ASST Papa Giovanni XXIIIRecruiting
Bergamo, Italy
IRCCS Azienda Ospedaliero- Universitaria di Bologna, Policlinico di Sant'OrsolaRecruiting
Bologna, Italy
IRCCS- Istituto Europeo di OncologiaRecruiting
Milan, Italy
Fondazione IRCCS San Gerardo Dei TintoriRecruiting
Monza, Italy
Azienda Ospedaliero- Universitaria Maggiore della CaritÃ, SCDU OncologiaRecruiting
Novara, Italy
National Cancer Centre SingaporeRecruiting
Singapore, Singapore
Curie Oncology - FarrerRecruiting
Singapore, Singapore
Inha University HospitalRecruiting
Incheon, South Korea
Seoul National University HospitalRecruiting
Seoul, South Korea
Severance Hospital, Yonsei University Health SystemRecruiting
Seoul, South Korea
Asan Medical CenterRecruiting
Seoul, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
Korea University Guro HospitalRecruiting
Seoul, South Korea
Hospital Universitario Virgen de la VictoriaRecruiting
Málaga, Andalusia, Spain
Hospital Universitario Virgen MacarenaRecruiting
Seville, Andalusia, Spain
Hospital Universitario De BasurtoRecruiting
Bilbao, Basque Country, Spain
Hospital Universitari Vall d'HebronRecruiting
Barcelona, Catalonia, Spain
Hospital Universitari Arnau de VillanovaRecruiting
Lleida, Catalonia, Spain
Hospital de la Santa Creu i Sant PauRecruiting
Barcelona, Spain
Hospital Beata Maria AnaRecruiting
Madrid, Spain
Barts Health NHS Trust - St Bartholomew's HospitalRecruiting
London, Greater London, United Kingdom
Velindre Cancer Centre, Velindre University NHS TrustRecruiting
Cardiff, Wales, United Kingdom
Nottingham University Hospital NHS TrustRecruiting
Nottingham, United Kingdom