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ASPEN-09-03: Evorpacept for HER2-Positive Metastatic Breast Cancer

This study is testing a new treatment combination for people with HER2-positive metastatic breast cancer. You might be able to join if you are 18 or older, have HER2-positive breast cancer that has spread, and have already received at least one prior treatment including trastuzumab deruxtecan (Enhertu). The study is looking at how well a drug called evorpacept works when given with trastuzumab and chemotherapy (paclitaxel, capecitabine, or eribulin). Researchers will measure the overall response rate, which means how many participants see their cancer shrink or disappear. This study is currently recruiting participants.

Study design
This is a Phase 2 study, meaning it's in an earlier stage of testing. It is a single-arm study, which means all participants receive the same treatment combination. It plans to enroll 120 participants.
What's involved
Participants will continue receiving study treatment until their disease gets worse, they experience side effects that are too difficult to manage, or they choose to stop. The study does not specify the number of visits or procedures.
Compensation
Not stated in the trial record.
Follow-up
The main goal of the study, overall response rate, will be measured approximately 6 months after the last participant joins.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07007559

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
ALX Oncology Inc.
~120 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:Evorpacept (ALX148)TrastuzumabPaclitaxelCapecitabineEribulinGemcitabine

At a glance

Recruiting sites
54 of 54 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Response Rate (ORR) using RECIST v1.1 based on BICR assessment
Measured over Approximately 6 months after the last participant is enrolled

Conditions

Breast Cancer, Metastatic

Explore related trials

Breast Carcinoma

Where it's being run

54 sites across 31 states
South Korea6
France5
Italy5
California3
Colorado3
Texas3
Singapore2
Andalusia2

Who to contact

Cheng Quah, MD
[email protected]
650-466-7125
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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

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:
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 trial measures

  • Overall Response Rate (ORR) using RECIST v1.1 based on BICR assessmentApproximately 6 months after the last participant is enrolled

    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.