NCT07007559From ClinicalTrials.govRecruiting

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

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

Breast Cancer, Metastatic

At a glance

Phase: Phase 2
Study type: Interventional
Sponsor: ALX Oncology Inc.
Enrolment target: 120
Started: 10 December 2025
Main results due: December 2027
Study sites: 60
Registry updated: 25 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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.

What this study is about

In the sponsor’s own words, from the registry.

The Substudy Protocol ASPEN-09-03 is a Phase 2, single-arm, multicenter study evaluating the efficacy, safety, and tolerability of evorpacept in combination with trastuzumab and chemotherapy in participants with HER2-positive metastatic breast cancer who have previously received trastuzumab-deruxtecan. This substudy is actively recruiting.

ASPEN-09-03 is a substudy under Master Protocol ASPEN-09, and additional substudies are as follows:

* Metastatic colorectal cancer (CRC) - dose escalation phase to evaluate evorpacept in combination with other drugs. This substudy is not open. * Recurrent/metastatic head and neck cancer (HNSCC) - dose escalation phase to evaluate evorpacept in combination with other drugs. This substudy is not open.

Study sites(60)

Mayo Clinic Building-Phoenix
Phoenix, Arizona, United States
Recruiting
The University of Arizona Cancer Center - North Campus
Tucson, Arizona, United States
Recruiting
City of Hope
Duarte, California, United States
Recruiting
UC San Diego Moores Cancer Center
La Jolla, California, United States
Recruiting
UC Irvine Health - Chao Family Comprehensive Cancer Center
Orange, California, United States
Recruiting
Saint Joseph Hospital - Cancer Centers of Colorado
Denver, Colorado, United States
Recruiting
Lutheran Hospital - Cancer Centers of Colorado
Golden, Colorado, United States
Recruiting
Saint Mary's Regional Hospital - Cancer Centers of Colorado
Grand Junction, Colorado, United States
Recruiting
The George Washington Medical facility Associates
Washington D.C., District of Columbia, United States
Recruiting
Mayo Clinic
Jacksonville, Florida, United States
Recruiting
Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Recruiting
Moffitt Cancer Center
Tampa, Florida, United States
Recruiting
City of Hope Chicago
Zion, Illinois, United States
Recruiting
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
Recruiting
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Recruiting
HealthPartners Frauenshuh Cancer Center
Saint Louis Park, Minnesota, United States
Recruiting
Washington University School of Medicine- Siteman Cancer Center
St Louis, Missouri, United States
Recruiting
St. Vincent Regional Hospital - Cancer Centers of Montana
Billings, Montana, United States
Recruiting
Oncology Hematology West, Pc Dba Nebraska Cancer Specialists
Omaha, Nebraska, United States
Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Recruiting
Duke Cancer Institute
Durham, North Carolina, United States
Recruiting
Gabrail Cancer Center
Canton, Ohio, United States
Recruiting
Oregon Health and Science University
Portland, Oregon, United States
Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Recruiting
Houston Methodist Cancer Center
Houston, Texas, United States
Recruiting
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
Recruiting
Virginia Cancer Specialists
Fairfax, Virginia, United States
Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Recruiting
University Health Network, Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Recruiting
CHU de Besancon
Besançon, France
Recruiting
Institut Bergonie
Bordeaux, France
Recruiting
Hopital de l'Institut Curie
Paris, France
Recruiting
Hopital Europeen Georges Pompidou (HEGP)
Paris, France
Recruiting
Centre Hospitalier Universitaire (CHU) de Poitiers
Poitiers, France
Recruiting
Centre Eugene Marquis
Rennes, France
Recruiting
Azienda Ospedaliero Universitaria delle Marche
Torrette, AN, Italy
Recruiting
IRCCS Azienda Ospedaliera Metropolitana
Genova, GE, Italy
Recruiting
ASST Papa Giovanni XXIII
Bergamo, Italy
Recruiting
IRCCS Azienda Ospedaliero- Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, Italy
Recruiting
IRCCS- Istituto Europeo di Oncologia
Milan, Italy
Recruiting
Fondazione IRCCS San Gerardo Dei Tintori
Monza, Italy
Recruiting
Azienda Ospedaliero- Universitaria Maggiore della CaritÃ, SCDU Oncologia
Novara, Italy
Recruiting
National Cancer Centre Singapore
Singapore, Singapore
Recruiting
Curie Oncology - Farrer
Singapore, Singapore
Recruiting
Inha University Hospital
Incheon, South Korea
Recruiting
Seoul National University Hospital
Seoul, South Korea
Recruiting
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Recruiting
Asan Medical Center
Seoul, South Korea
Recruiting
Samsung Medical Center
Seoul, South Korea
Recruiting
Korea University Guro Hospital
Seoul, South Korea
Recruiting
Hospital Universitario Virgen de la Victoria
Málaga, Andalusia, Spain
Recruiting
Hospital Universitario Virgen Macarena
Seville, Andalusia, Spain
Recruiting
Hospital Universitario De Basurto
Bilbao, Basque Country, Spain
Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, Catalonia, Spain
Recruiting
Hospital Universitari Arnau de Villanova
Lleida, Catalonia, Spain
Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Recruiting
Hospital Beata Maria Ana
Madrid, Spain
Recruiting
Barts Health NHS Trust - St Bartholomew's Hospital
London, Greater London, United Kingdom
Recruiting
Velindre Cancer Centre, Velindre University NHS Trust
Cardiff, Wales, United Kingdom
Recruiting
Nottingham University Hospital NHS Trust
Nottingham, United Kingdom
Recruiting

Showing 60 of 60 sites. 60 of the 60 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07007559. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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