RecruitingPHASE2INTERVENTIONAL

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

This study is called ASPEN-09-03 and is for people with a type of breast cancer called HER2-positive metastatic breast cancer. This means the cancer has spread to other parts of the body. The study is looking at a new medicine called evorpacept, which will be given together with trastuzumab and chemotherapy. These treatments are given to people who have already had a specific treatment called trastuzumab-deruxtecan, and whose cancer has continued to grow or spread. The main goals are to find out if this combination of medicines is safe, how well people tolerate it, and how effective it is in treating the cancer. The study is currently looking for participants.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

ALX Oncology Inc.

Enrolment target

120

Start

10 Dec 2025

Estimated completion

01 Dec 2028

Breast Cancer, Metastatic

What is this study about?

This clinical trial, known as ASPEN-09-03, is investigating a new treatment approach for HER2-positive breast cancer that has spread to other parts of the body (also called metastatic breast cancer). In this study, a new drug called evorpacept is being tested in combination with two existing treatments: trastuzumab and chemotherapy. These treatments will be given to people whose cancer has already been treated with a medicine called trastuzumab-deruxtecan, but has since started to grow again or progress.

The main purpose of this study is to gather more information. Researchers want to understand if adding evorpacept to existing treatments is safe and if it can help slow down or stop the growth of HER2-positive metastatic breast cancer. This study is a 'Phase 2' trial, which means it builds on earlier research and focuses on how well the new treatment combination works and its safety in a larger group of people.

Participants will continue to receive the study treatments until their cancer gets worse, they experience strong side effects they can't manage, or they decide to stop for any reason. This study is actively recruiting patients, meaning they are looking for people who fit the study criteria to join. There are no other parts of this larger study currently open for other types of cancer, so the focus is entirely on HER2-positive metastatic breast cancer at this time.

Key takeaways

This study is for HER2-positive breast cancer that has spread.
It tests a new drug, evorpacept, with existing treatments (trastuzumab and chemotherapy).
It's for patients whose cancer has progressed after trastuzumab-deruxtecan.
The goal is to check safety and how well the new combination works.
Participation involves regular clinic visits and continuous treatment as long as it helps.
You can stop participating at any time if you wish.

Who may be eligible?

To join this study, you must have HER2-positive breast cancer that has spread. You need to have already received a specific treatment called trastuzumab-deruxtecan (Enhertu) for your widespread breast cancer. Your cancer should have grown or progressed after your last treatment.

You must be generally well enough to receive one of several specific chemotherapy options, such as capecitabine, eribulin, gemcitabine, paclitaxel, or vinorelbine. Doctors will also check that your heart, kidney, and liver functions are healthy enough for the treatments, and that you can move around and perform daily activities well.

There are also reasons why you might not be able to join. For example, if your cancer has spread to your brain (unless it's been successfully treated and is stable), or if you've already had certain types of new experimental drugs. You also can't join if you have certain other serious health issues that might make the study treatments unsafe for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have HER2-positive breast cancer that has spread?
Have I already been treated with trastuzumab-deruxtecan (Enhertu) for my widespread cancer?
Has my cancer grown or worsened after my last treatment?
Am I generally well enough to have chemotherapy (e.g., capecitabine, paclitaxel)?
Are my heart, kidneys, and liver healthy enough for treatment?
Have I recovered from most side effects of my previous treatments?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will receive a combination of medicines: the new drug evorpacept, along with trastuzumab, and one of several chemotherapy options. You will have regular visits to the clinic for these treatments and to have check-ups to see how you are doing. During these visits, doctors will monitor your health closely, including blood tests, scans, and other examinations, to see how the treatment is affecting you and your cancer.

The study treatment will continue for as long as it is helping you and you are tolerating it well. This means there isn't a fixed end date like with some treatments; you'll continue until your cancer progresses, if you experience side effects that are too difficult to manage, or if you decide you no longer wish to participate. The total duration of your participation will depend on how you respond to the treatment.

Potential risks and benefits

Participating in a clinical trial can offer potential benefits, such as gaining access to a new experimental treatment (evorpacept) that might be more effective than standard options. However, there are also potential risks involved. The treatments, including the new drug and chemotherapy, can cause side effects. These can range from mild to severe and will be carefully monitored by the study team. You will be given full information about all known potential side effects before you decide to join. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (32)

The University of Arizona Cancer Center - North Campus
Verified postcode
Tucson, United States· Recruiting
City of Hope
Verified postcode
Duarte, United States· Recruiting
Saint Joseph Hospital - Cancer Centers of Colorado
Verified postcode
Denver, United States· Recruiting
Lutheran Hospital - Cancer Centers of Colorado
Verified postcode
Golden, United States· Recruiting
Saint Mary's Regional Hospital - Cancer Centers of Colorado
Verified postcode
Grand Junction, United States· Recruiting
The George Washington Medical facility Associates
Verified postcode
Washington D.C., United States· Recruiting
City of Hope Chicago
Verified postcode
Zion, United States· Recruiting
University of Michigan Rogel Cancer Center
Verified postcode
Ann Arbor, United States· Recruiting
HealthPartners Frauenshuh Cancer Center
Verified postcode
Saint Louis Park, United States· Recruiting
St. Vincent Regional Hospital - Cancer Centers of Montana
Verified postcode
Billings, United States· Recruiting
Oncology Hematology West, Pc Dba Nebraska Cancer Specialists
Verified postcode
Omaha, United States· Recruiting
Gabrail Cancer Center
Verified postcode
Canton, United States· Recruiting

Common questions

What is HER2-positive breast cancer?

This is a type of breast cancer that has a lot of a protein called HER2, which helps cancer cells grow. Treatments that target HER2 can be very effective.

What does 'metastatic' mean?

Metastatic means the cancer has spread from where it started (in this case, the breast) to other parts of your body, like the bones, lungs, or liver.

What is evorpacept, and how does it work?

Evorpacept is a new investigational drug. It works by blocking a signal that cancer cells use to tell the immune system not to attack them. By blocking this signal, it's hoped your immune system can better fight the cancer.

I've already had Enhertu (trastuzumab-deruxtecan). Can I still join?

Yes, this study is specifically for people with HER2-positive metastatic breast cancer who have already received trastuzumab-deruxtecan.

Will I receive a placebo?

No, this study is not testing a placebo. All participants will receive the active study treatment combination of evorpacept, trastuzumab, and chemotherapy.

How to find out more

Cheng Quah, MD

info@alxoncology.com 650-466-7125 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.