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New combo therapy aims to outsmart resistant breast cancer

NCT ID NCT07007559

Disease control Sponsor: ALX Oncology Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 14, 2026 · Updated 2 times

Summary

This phase 2 trial is testing whether adding evorpacept to standard trastuzumab and chemotherapy can shrink tumors in people with metastatic HER2-positive breast cancer who have already tried the drug Enhertu. About 120 participants will receive the combination intravenously. The study is currently recruiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
evorpacept (ALX148) combined with trastuzumab (Herceptin) and chemotherapy (paclitaxel, capecitabine, eribulin, gemcitabine, or vinorelbine)
What this could lead to
If successful, this could offer a new treatment option for people with HER2-positive breast cancer that has spread and stopped responding to current therapies.
What could go wrong
This is a small, early-phase trial (Phase 2) with no control group, so results may not prove the combination works better than existing treatments. Side effects from the drug combination are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm HER2 positive breast carcinoma Neoplasm Metastasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer, metastatic

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    54 sites in 8 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • ASST Papa Giovanni XXIII

    RECRUITING

    Bergamo, 24127, Italy

  • Asan Medical Center

    RECRUITING

    Seoul, 05505, South Korea

  • Azienda Ospedaliero Universitaria delle Marche

    RECRUITING

    Torrette, AN, 60126, Italy

  • Azienda Ospedaliero- Universitaria Maggiore della CaritÃ, SCDU Oncologia

    RECRUITING

    Novara, 28100, Italy

  • Barts Health NHS Trust - St Bartholomew's Hospital

    RECRUITING

    London, Greater London, EC1A 7BE, United Kingdom

  • CHU de Besancon

    RECRUITING

    Besançon, 25030, France

  • Centre Eugene Marquis

    RECRUITING

    Rennes, 35042, France

  • Centre Hospitalier Universitaire (CHU) de Poitiers

    RECRUITING

    Poitiers, 86000, France

  • City of Hope

    RECRUITING

    Duarte, California, 91010, United States

  • City of Hope Chicago

    RECRUITING

    Zion, Illinois, 60099, United States

  • Curie Oncology - Farrer

    RECRUITING

    Singapore, 217562, Singapore

  • Fondazione IRCCS San Gerardo Dei Tintori

    RECRUITING

    Monza, 20900, Italy

  • Fred Hutchinson Cancer Center

    RECRUITING

    Seattle, Washington, 98109, United States

  • Gabrail Cancer Center

    RECRUITING

    Canton, Ohio, 44718, United States

  • HealthPartners Frauenshuh Cancer Center

    RECRUITING

    Saint Louis Park, Minnesota, 55426, United States

  • Hopital Europeen Georges Pompidou (HEGP)

    RECRUITING

    Paris, 75015, France

  • Hopital de l'Institut Curie

    RECRUITING

    Paris, 75005, France

  • Hospital Beata Maria Ana

    RECRUITING

    Madrid, 28007, Spain

  • Hospital Universitari Arnau de Villanova

    RECRUITING

    Lleida, Catalonia, 25198, Spain

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, Catalonia, 08035, Spain

  • Hospital Universitario De Basurto

    RECRUITING

    Bilbao, Basque Country, 48013, Spain

  • Hospital Universitario Virgen Macarena

    RECRUITING

    Seville, Andalusia, 41009, Spain

  • Hospital Universitario Virgen de la Victoria

    RECRUITING

    Málaga, Andalusia, 29010, Spain

  • Hospital de la Santa Creu i Sant Pau

    RECRUITING

    Barcelona, 08041, Spain

  • Houston Methodist Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • IRCCS Azienda Ospedaliera Metropolitana

    RECRUITING

    Genova, GE, 16132, Italy

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

    RECRUITING

    Bologna, 40138, Italy

  • IRCCS- Istituto Europeo di Oncologia

    RECRUITING

    Milan, 20141, Italy

  • Inha University Hospital

    RECRUITING

    Incheon, 22332, South Korea

  • Korea University Guro Hospital

    RECRUITING

    Seoul, 08308, South Korea

  • Lutheran Hospital - Cancer Centers of Colorado

    RECRUITING

    Golden, Colorado, 80401, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10022, United States

  • National Cancer Centre Singapore

    RECRUITING

    Singapore, 168583, Singapore

  • Nottingham University Hospital NHS Trust

    RECRUITING

    Nottingham, NG5 1PB, United Kingdom

  • Oncology Hematology West, Pc Dba Nebraska Cancer Specialists

    RECRUITING

    Omaha, Nebraska, 68130, United States

  • Oregon Health and Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Saint Joseph Hospital - Cancer Centers of Colorado

    RECRUITING

    Denver, Colorado, 80218, United States

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

    RECRUITING

    Grand Junction, Colorado, 81501, United States

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    RECRUITING

    Seoul, 03722, South Korea

  • St. Vincent Regional Hospital - Cancer Centers of Montana

    RECRUITING

    Billings, Montana, 59102, United States

  • Sylvester Comprehensive Cancer Center

    RECRUITING

    Miami, Florida, 33136, United States

  • The George Washington Medical facility Associates

    RECRUITING

    Washington D.C., District of Columbia, 20037, United States

  • The University of Arizona Cancer Center - North Campus

    RECRUITING

    Tucson, Arizona, 85719, United States

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

    RECRUITING

    Houston, Texas, 77030, United States

  • UC Irvine Health - Chao Family Comprehensive Cancer Center

    RECRUITING

    Orange, California, 928686, United States

  • UC San Diego Moores Cancer Center

    RECRUITING

    La Jolla, California, 92037, United States

  • University Health Network, Princess Margaret Cancer Centre

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • University of Michigan Rogel Cancer Center

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • Velindre Cancer Centre, Velindre University NHS Trust

    RECRUITING

    Cardiff, Wales, CF14 2TL, United Kingdom

  • Virginia Cancer Specialists

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Washington University School of Medicine- Siteman Cancer Center

    RECRUITING

    St Louis, Missouri, 63108, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.