Tests evorpacept with trastuzumab and chemotherapy in advanced HER2-positive breast cancer
Tests evorpacept with trastuzumab and chemotherapy in adults with spread HER2-positive breast cancer.
Plain-language title generated from the registry record
Registry title: ASPEN-09-03: A Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Metastatic HER2-Positive Breast Cancer
Key facts
- Where
- Besançon, Bordeaux, Paris, Poitiers, Rennes, and Villejuif, FranceSee the 7 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with metastatic HER2-positive breast cancer that got worse after earlier treatment including trastuzumab-deruxtecan (T-DXd, ENHERTU). Everyone receives evorpacept with trastuzumab and chemotherapy.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Invasive HER2-positive breast cancer that is locally advanced or metastatic, with measurable disease (RECIST v1.1). The cancer must have progressed on or after the most recent treatment.
- Earlier treatment
- At least one earlier treatment line with T-DXd (ENHERTU) and no more than 4 earlier lines of HER2-directed therapy. People who stopped T-DXd because they could not tolerate it can join. Anti-cancer treatment must be stopped before starting: 14 days or 5 half-lives for chemotherapy, hormone, radiation or small molecule therapy, and 28 days or 5 half-lives for immune or other biologic therapy.
- Biomarker or test result
- HER2-positive breast cancer confirmed on a tumor biopsy taken after T-DXd ended and no more than 6 months before the start of treatment. Heart pumping function (LVEF) of 50% or more.
Main reasons for not taking part
- Brain or spinal cord (CNS) metastases that have not been treated
- Earlier treatment with an anti-CD47 or anti-SIRPα drug
- Earlier allogeneic tissue or solid organ transplant
- Active autoimmune disease that needed systemic treatment in the past 2 years, or active unstable heart disease
- Another primary cancer within the past 2 years
Read by machine on 12 November 2026.
Where in France
- CHU de BesançonBesançon, FranceContact: Cheng Quah, MDTaking people
- Institut BergonieBordeaux, FranceContact: Cheng Quah, MDTaking people
- Hopital de l'Institut CurieParis, FranceContact: Cheng Quah, MDTaking people
- Hôpital Européen Georges Pompidou (HEGP)Paris, FranceContact: Cheng Quah, MDTaking people
- Centre Hospitalier Universitaire (CHU) de PoitiersPoitiers, FranceContact: Cheng Quah, MDTaking people
- Centre Eugène MarquisRennes, FranceContact: Cheng Quah, MDTaking people
- Gustave RoussyVillejuif, FranceContact: Cheng Quah, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- ALX Oncology Inc.
- Trial code
- NCT07007559
- Record updated
- 9 November 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: 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; 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); Had an allogeneic tissue/solid organ transplant; History of autoimmune hemolytic anemia, autoimmune thrombocytopenia, or hemolytic transfusion reaction; 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; Untreated CNS metastases.