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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (3 UK sites)
Barts Health NHS Trust - St Bartholomew's Hospital
London EC1A 7BE, United Kingdom
Velindre Cancer Centre, Velindre University NHS Trust
Cardiff CF14 2TL, United Kingdom
Nottingham University Hospital NHS Trust
Nottingham NG5 1PB, United Kingdom
How to Get in Touch
Cheng Quah, MD
Sponsor contactCONTACT
