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Breast Cancer, MetastaticPhase 2ASPEN-09-03NCT07007559

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

A Phase 2 study testing Evorpacept (ALX148), Trastuzumab and Paclitaxel in people with Breast Cancer, Metastatic, run by ALX Oncology Inc. at 60 sites in 8 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer, Metastatic
What is being tested?
Evorpacept (ALX148), Trastuzumab and Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
60 sitesin 8 countries
Study dates
10 Dec 2025to Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%.
Show all 13Show fewer
  • 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.

Who cannot join

  • 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:
  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

60 sites in 8 countries. Contact the study team or a site near you to ask about taking part.

Cheng Quah, MD contact

650-466-7125

info@alxoncology.com

60 sites in 8 countries

United States28 sites, 28 recruiting

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

    Recruiting

  • St. Vincent Regional Hospital - Cancer Centers of Montana

    Billings, Montana, 59102

    Recruiting

  • Gabrail Cancer Center

    Canton, Ohio, 44718

    Study Coordinator

    Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

    Recruiting

  • Saint Joseph Hospital - Cancer Centers of Colorado

    Denver, Colorado, 80218

    Recruiting

  • City of Hope

    Duarte, California, 91010

    Recruiting

  • Duke Cancer Institute

    Durham, North Carolina, 27710

    Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

    Recruiting

  • Lutheran Hospital - Cancer Centers of Colorado

    Golden, Colorado, 80401

    Recruiting

  • Saint Mary's Regional Hospital - Cancer Centers of Colorado

    Grand Junction, Colorado, 81501

    Recruiting

  • Houston Methodist Cancer Center

    Houston, Texas, 77030

    Recruiting

  • The University of Texas M.D. Anderson Cancer Center

    Houston, Texas, 77030

    Recruiting

  • Mayo Clinic

    Jacksonville, Florida, 32224

    Recruiting

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92037

    Recruiting

  • Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10022

    Recruiting

  • Oncology Hematology West, Pc Dba Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

    Study Coordinator, 402-334-4773

    Recruiting

  • UC Irvine Health - Chao Family Comprehensive Cancer Center

    Orange, California, 928686

    Recruiting

  • Mayo Clinic Building-Phoenix

    Phoenix, Arizona, 85054

    Recruiting

  • Oregon Health and Science University

    Portland, Oregon, 97239

    Recruiting

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

    Recruiting

  • HealthPartners Frauenshuh Cancer Center

    Saint Louis Park, Minnesota, 55426

    Study Coordinator

    Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

    Recruiting

  • Washington University School of Medicine- Siteman Cancer Center

    St Louis, Missouri, 63108

    Recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Recruiting

  • The University of Arizona Cancer Center - North Campus

    Tucson, Arizona, 85719

    Recruiting

  • The George Washington Medical facility Associates

    Washington D.C., District of Columbia, 20037

    Recruiting

  • City of Hope Chicago

    Zion, Illinois, 60099

    Recruiting

Other trials in United States

Italy7 sites, 7 recruiting

  • ASST Papa Giovanni XXIII

    Bergamo, 24127

    Recruiting

  • IRCCS Azienda Ospedaliero- Universitaria di Bologna, Policlinico di Sant'Orsola

    Bologna, 40138

    Recruiting

  • IRCCS Azienda Ospedaliera Metropolitana

    Genova, GE, 16132

    Recruiting

  • IRCCS- Istituto Europeo di Oncologia

    Milan, 20141

    Recruiting

  • Fondazione IRCCS San Gerardo Dei Tintori

    Monza, 20900

    Recruiting

  • Azienda Ospedaliero- Universitaria Maggiore della CaritÃ, SCDU Oncologia

    Novara, 28100

    Recruiting

  • Azienda Ospedaliero Universitaria delle Marche

    Torrette, AN, 60126

    Recruiting

Other trials in Italy

Spain7 sites, 7 recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, Catalonia, 08035

    Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

    Recruiting

  • Hospital Universitario De Basurto

    Bilbao, Basque Country, 48013

    Recruiting

  • Hospital Universitari Arnau de Villanova

    Lleida, Catalonia, 25198

    Recruiting

  • Hospital Beata Maria Ana

    Madrid, 28007

    Recruiting

  • Hospital Universitario Virgen de la Victoria

    Málaga, Andalusia, 29010

    Recruiting

  • Hospital Universitario Virgen Macarena

    Seville, Andalusia, 41009

    Recruiting

Other trials in Spain

France6 sites, 6 recruiting

  • CHU de Besancon

    Besançon, 25030

    Recruiting

  • Institut Bergonie

    Bordeaux, 33076

    Recruiting

  • Hopital de l'Institut Curie

    Paris, 75005

    Recruiting

  • Hopital Europeen Georges Pompidou (HEGP)

    Paris, 75015

    Recruiting

  • Centre Hospitalier Universitaire (CHU) de Poitiers

    Poitiers, 86000

    Recruiting

  • Centre Eugene Marquis

    Rennes, 35042

    Recruiting

Other trials in France

South Korea6 sites, 6 recruiting

  • Inha University Hospital

    Incheon, 22332

    Recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

    Recruiting

  • Asan Medical Center

    Seoul, 05505

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Recruiting

  • Korea University Guro Hospital

    Seoul, 08308

    Recruiting

Other trials in South Korea

United Kingdom3 sites, 3 recruiting

  • Velindre Cancer Centre, Velindre University NHS Trust

    Cardiff, Wales, CF14 2TL

    Recruiting

  • Barts Health NHS Trust - St Bartholomew's Hospital

    London, Greater London, EC1A 7BE

    Recruiting

  • Nottingham University Hospital NHS Trust

    Nottingham, NG5 1PB

    Recruiting

Other trials in United Kingdom

Singapore2 sites, 2 recruiting

  • National Cancer Centre Singapore

    Singapore, 168583

    Recruiting

  • Curie Oncology - Farrer

    Singapore, 217562

    Recruiting

Other trials in Singapore

Canada1 site, 1 recruiting

  • University Health Network, Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

    Recruiting

Other trials in Canada

About this study

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

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.
Read the detailed description

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.

Being tested
Evorpacept (ALX148), Trastuzumab, Paclitaxel, Capecitabine, Eribulin
Keywords
metastatic, Her2+, metastatic HER2-positive breast cancer, breast cancer, HER2-positive, Evorpacept, CD47, ERBB2, Enhertu, trastuzumab deruxtecan, ASPEN-09, Herceptin, solid tumors, trastuzumab, ALX148, mBC, ASPEN-Breast
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Evorpacept (ALX148)Drug

    IV infusion

  • TrastuzumabDrug

    Also called Herceptin

    IV infusion

  • PaclitaxelDrug

    Also called Taxol

    IV infusion

  • CapecitabineDrug

    Also called Xeloda

    Oral administration

  • EribulinDrug

    Also called Halaven

    IV infusion

  • GemcitabineDrug

    Also called Gemzar

    IV infusion

  • VinorelbineDrug

    Also called Navelbine

    IV infusion

Study groups in NCT07007559
Study groupRoleWhat they receive
Evorpacept+Trastuzumab+Chemo in participants with metastatic HER2+ breast cancerExperimental* Evorpacept (IV) - once every 3 weeks (Q3W) * Trastuzumab (IV) - once every 3 weeks (Q3W) * Chemotherapy (physician selects one of the following): * Capecitabine (Oral) twice a day for 14 days every 3 weeks * Eribulin (IV) twice every 3 weeks * Gemcitabine (IV) twice every 3 weeks * Paclitaxel (IV) once every 3 weeks (Q3W) or once weekly (QW) * Vinolrebine (IV) twice every 3 weeks
Receives: Drug: Evorpacept (ALX148); Drug: Trastuzumab; Drug: Paclitaxel; Drug: Capecitabine; Drug: Eribulin; Drug: Gemcitabine; Drug: Vinorelbine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate (ORR) using RECIST v1.1 based on BICR assessment

    Evaluate the ORR of evorpacept in combination with trastuzumab and single-agent chemotherapy in the sub-population of participants with metastatic HER2-positive breast cancer who express CD47 (CD47+). ORR is defined as a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) using RECIST v1.1 based on BICR assessment.

    Measured: Approximately 6 months after the last participant is enrolled

Secondary outcomes (12)

  1. Overall Response Rate (ORR) based on Investigator assessment

    Evaluate the ORR of evorpacept in combination with trastuzumab and single-agent chemotherapy in the sub-population of participants with metastatic HER2-positive breast cancer who express CD47 (CD47+). ORR is defined as a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) based on Investigator Assessment.

    Measured: Approximately 6 months after the last participant is enrolled

  2. Clinical Benefit Rate (CBR) using RECIST v1.1 based on BICR and Investigator assessment

    Evaluate the CBR of evorpacept in combination with trastuzumab and single-agent chemotherapy in the sub-population of participants with metastatic HER2-positive breast cancer who express CD47 (CD47+). CBR is defined as the proportion of participants whose BOR is confirmed PR, confirmed CR, or SD with duration >6 months using RECIST v1.1 based on BICR and Investigator assessment.

    Measured: Approximately 6 months after the last participant is enrolled

  3. Duration of Response (DoR) using RECIST v1.1 based on BICR and Investigator assessment

    Evaluate the DoR of evorpacept in combination with trastuzumab and single-agent chemotherapy in the sub-population of participants with metastatic HER2-positive breast cancer who express CD47 (CD47+). DoR is measured from the time measurement criteria are first met for CR / PR (whichever is first recorded) until documented progressive disease or death from any cause, whichever occurs first using RECIST v1.1 based on BICR and Investigator assessment.

    Measured: Approximately 6 months after the last participant is enrolled

  4. Progression-Free Survival (PFS) using RECIST v1.1 based on BICR and Investigator assessment

    Evaluate the PFS of evorpacept in combination with trastuzumab and single-agent chemotherapy in the sub-population of participants with metastatic HER2-positive breast cancer who express CD47 (CD47+). PFS is measured from the date of enrollment until documented progressive disease or death from any cause, whichever occurs first, using RECIST v1.1 based on BICR and Investigator assessment

    Measured: Approximately 6 months after the last participant is enrolled

  5. Overall Survival (OS)

    Evaluate the OS of evorpacept in combination with trastuzumab and single-agent chemotherapy in the sub-population of participants with metastatic HER2-positive breast cancer who express CD47 (CD47+). OS is defined as the time from the date of enrollment until death.

    Measured: Approximately 6 months after the last participant is enrolled

  6. Number of participants with adverse events (AEs) and with laboratory abnormalities

    AEs as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), timing, seriousness, and relationship to study drug. Laboratory abnormalities as characterized by type, frequency, severity, and timing.

    Measured: Enrollment to 28 days after the last administration of the study drug

  7. Maximum Concentration (Cmax)

    To evaluate the Cmax of evorpacept

    Measured: Approximately 6 months after the last participant is enrolled

  8. Time at Maximum Concentration (Tmax)

    To evaluate the Tmax of evorpacept

    Measured: Approximately 6 months after the last participant is enrolled

  9. Area under the Concentration-Time Curve (AUC)

    To evaluate the AUC of evorpacept

    Measured: Approximately 6 months after the last participant is enrolled

  10. Clearance (CL)

    To evaluate the CL of evorpacept

    Measured: Approximately 6 months after the last participant is enrolled

  11. Terminal elimination half-life (t1/2)

    To evaluate the t1/2 of evorpacept

    Measured: Approximately 6 months after the last participant is enrolled

  12. Evaluate the immunogenicity of evorpacept

    Measured by presence of human serum ADA (anti-evorpacept antibodies)

    Measured: Approximately 6 months after the last participant is enrolled

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2025
  2. Study start10 Dec 2025
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07007559
Sponsor's protocol ID
AT148009
Acronym
ASPEN-09-03
Status last verified
Aug 2026
First submitted
22 May 2025
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Evorpacept (ALX148), Trastuzumab and Paclitaxel in people with Breast Cancer, Metastatic, run by ALX Oncology Inc. at 60 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in United States, Italy, Spain, France, South Korea and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cheng Quah, MD (650-466-7125, info@alxoncology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) using RECIST v1.1 based on BICR assessment (time frame: Approximately 6 months after the last participant is enrolled). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07007559.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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