Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsPhase2

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

Sponsor: ALX Oncology Inc.

NCT ID: NCT07007559

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Evorpacept (ALX148) (drug), Trastuzumab (drug), Paclitaxel (drug), Capecitabine (drug)
How long the study runs
Study runs about 36 months (dates as stated)
About the drug or intervention
Evorpacept (ALX148) — drug: IV infusion · Trastuzumab — drug: IV infusion · Paclitaxel — drug: IV infusion · Capecitabine — drug: Oral administration · Eribulin — drug: IV infusion · Gemcitabine — drug: IV infusion · Vinorelbine — drug: IV infusion
Patient visit burden
Not specified by the sponsor

In plain English

This study is for people with breast cancer that has spread to other parts of the body (metastatic) and has too much of a protein called HER2 on the cancer cells. It tests a new drug called evorpacept together with trastuzumab (an existing HER2 medicine) and chemotherapy. The study is run by ALX Oncology Inc.

Who can take part

  • Have breast cancer confirmed by a tissue test as HER2-positive, with a biopsy taken after stopping a drug called T-DXd (ENHERTU) and no more than 6 months before treatment starts
  • Have had no more than 4 previous HER2 treatments, including at least one treatment with T-DXd (ENHERTU). People who stopped T-DXd because they could not tolerate it can still take part
  • Their cancer has grown or spread during or after their most recent treatment
  • Are able to receive one of these chemotherapy drugs: capecitabine, eribulin, gemcitabine, paclitaxel or vinorelbine
  • Have cancer that can be measured on scans
  • Have a heart pumping function (LVEF) of 50% or more
  • Are fairly well and active (performance status 0 to 1 on a scale used by doctors)
  • Are expected to live at least 3 more months
  • Have healthy enough kidneys and liver, shown by blood tests
  • Have recovered from side effects of earlier treatments, apart from lasting effects judged not to be a safety risk

Who may not be able to

  • Have cancer spread to the brain that has not been treated
  • Have had any drug targeting CD47 or SIRPα before
  • Have any condition that makes trastuzumab unsafe for them
  • Have complete DPD deficiency or bad reactions to a chemotherapy called 5FU in the past
  • Have had certain cancer treatments too recently before the study starts
  • Have a history of autoimmune blood disorders, such as autoimmune haemolytic anaemia or autoimmune low platelets, or a reaction to a blood transfusion
  • Have had a donor (allogeneic) tissue or organ transplant
  • Have active or unstable heart disease
  • Have had severe allergic or anaphylactic reactions to antibodies, infused protein medicines, or anything in the study drugs
  • Have an active autoimmune disease that needed body-wide treatment in the past 2 years
  • Have had another type of cancer in the past 2 years

What taking part involves

  • • Taking the study drug evorpacept
  • • Receiving trastuzumab, an existing HER2-targeted medicine
  • • Receiving one of these chemotherapy drugs: capecitabine, eribulin, gemcitabine, paclitaxel or vinorelbine

Time commitment: Not stated — ask the trial team

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
120
Started
2025-12-10
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for breast cancer, metastatic
  • • Phase2 - 120 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with breast cancer, metastatic

Where?

  • • London - Barts Health NHS Trust - St Bartholomew's Hospital
  • • Cardiff - Velindre Cancer Centre, Velindre University NHS Trust
  • • Nottingham - Nottingham University Hospital NHS Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Breast Cancer, Metastatic

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

HER2CD47

Treatment history

Treatments you must have had:

  • ✓ of T-DXd (ENHERTU) f

What the study is looking for

  • ✓confirmed by a biopsy invasive HER2+ breast cancer based on an evaluable tumor tissue biopsy obtained after...
  • ✓Progressed on or following the most recent line of therapy.
  • ✓Eligible to receive one of the following drug treatment options (capecitabine, eribulin, gemcitabine, paclitaxel or...
  • ✓cancer that can be measured on scans as defined by (standard scan measurements).
  • ✓LVEF ≥50%.

Who cannot take part

  • ✗Untreated CNS metastases.
  • ✗Prior exposure to any anti-CD47 or anti-SIRPα agent.
  • ✗Any condition that would be not safe to use to receiving trastuzumab
  • ✗Has a diagnosis of complete dihydropyrimidine dehydrogenase (DPD) deficiency or significant toxicity with prior...
  • ✗Following anti-cancer therapy with insufficient washout before start of treatment:
See the full 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.

Where Is This Study? (3 UK sites)

Barts Health NHS Trust - St Bartholomew's Hospital

London EC1A 7BE, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Mays Jawad

research.governance@qmul.ac.uk020 7882 6826

Velindre Cancer Centre, Velindre University NHS Trust

Cardiff CF14 2TL, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Townsend

Velindre.R&Doffice@wales.nhs.uk02920 196165

Nottingham University Hospital NHS Trust

Nottingham NG5 1PB, United Kingdom

Recruiting
Hospital R&D contact (matched)

Alison Lloyd

nuhnt.researchsponsor@nhs.net0115 9249924

How to Get in Touch

Cheng Quah, MD

Sponsor contact

CONTACT

650-466-7125 info@alxoncology.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-08