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Active not recruitingPHASE2, PHASE3INTERVENTIONAL

A Study of Evorpacept (ALX148) in Patients With Advanced HER2+ Gastric Cancer (ASPEN-06)

The ASPEN-06 study investigated a new experimental drug named Evorpacept (also known as ALX148) for individuals in the UK with advanced forms of HER2-positive stomach cancer, including gastric cancer and gastroesophageal junction adenocarcinoma. This type of cancer has too much of a protein called HER2. The study aimed to test Evorpacept alongside existing treatments like Trastuzumab, Ramucirumab, and Paclitaxel, to see if this combination could offer a better way to treat the disease. Participants would have already received some previous treatments that were no longer working as well. While the study was initially planned for two stages (Phase 2 and Phase 3), the sponsors ultimately decided not to continue with the second, larger stage (Phase 3) due to strategic business considerations. This means the study has now concluded.

At a glance

Status
Active not recruiting
Phase
PHASE2, PHASE3
Sponsor
ALX Oncology Inc.
Enrolment target
127
Start
15 Jan 2022
Estimated completion
01 Jun 2026

What is this study about?

This study, known as ASPEN-06, focused on a specific type of advanced stomach cancer. This includes cancer in the stomach itself (gastric cancer) or at the point where the food pipe meets the stomach (gastroesophageal junction adenocarcinoma). Specifically, it looked at cancers that are 'HER2-positive,' meaning they have a lot of a protein called HER2, which can help cancer grow. The study was testing a new, experimental medicine called Evorpacept (also known as ALX148).

The main idea behind the study was to see if adding Evorpacept to treatments that patients were already receiving, such as Trastuzumab, Ramucirumab, and Paclitaxel, could be more effective. Participants had already received some initial treatments for their HER2-positive stomach cancer, and their cancer had either continued to grow or come back. The study initially planned to have two stages: a smaller, early stage (Phase 2) to get an idea of how well it worked and its safety, followed by a larger, later stage (Phase 3) involving more patients to confirm the findings.

However, it's important to know that the part of the study that would have involved a larger number of patients (Phase 3) has now been stopped. The company sponsoring the study made this decision due to 'strategic considerations.' This means they decided, for their own business reasons, not to continue exploring Evorpacept for this specific group of patients. Therefore, the ASPEN-06 study is no longer recruiting new patients.

Key takeaways

  • The ASPEN-06 study investigated Evorpacept for advanced HER2-positive stomach cancer.
  • It combined Evorpacept with existing standard treatments.
  • The larger, later stage (Phase 3) of the study was stopped for strategic business reasons.
  • The study is no longer recruiting new participants.
  • This type of research helps improve future cancer treatments.

Who may be eligible?

To have been considered for this study, patients needed to be at least 18 years old and have advanced stomach cancer that tested positive for the HER2 protein. This cancer would have already progressed or returned after previous treatments, including at least one HER2-targeted therapy and certain types of chemotherapy. Additionally, patients would need to be well enough to receive further chemotherapy treatments. The medical team would have checked key body functions, like bone marrow, kidney, and liver health, to ensure they were working adequately.

There were also specific reasons why someone would not have been able to join. For example, if the cancer had spread to the brain and was causing significant symptoms requiring strong medication, or if they had previously received certain experimental drugs that targeted similar pathways as Evorpacept. Patients who had already been treated with Ramucirumab, one of the standard drugs used in this study, would also not have been eligible to participate.

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.

  1. Are you at least 18 years old?
  2. Do you have advanced HER2-positive stomach cancer?
  3. Has your cancer progressed after previous HER2-targeted therapy and chemotherapy?
  4. Are you generally well enough to receive further chemotherapy?
  5. Have you NOT had previous treatment with ramucirumab or similar experimental drugs?
Answer every question to see your result.

What does participation involve?

As this study has now stopped, no new patients can take part. However, if it were ongoing, participation would typically involve regular visits to the hospital or clinic. These visits would include physical examinations, blood tests, and scans (like CT scans) to monitor your health and how the treatment is working. You would receive the study medication (Evorpacept) along with standard cancer treatments through infusions (drips). The frequency and duration of these visits would depend on the specific treatment plan, but cancer studies often involve frequent visits initially, gradually becoming less frequent. There would also be follow-up appointments after the main treatment phase to continue monitoring your health over a longer period.

Potential risks and benefits

Participating in research studies like ASPEN-06 offers the chance to access new, experimental treatments that aren't yet widely available, and it helps advance medical knowledge for potentially better future care. However, experimental drugs can have side effects that are not yet fully understood, and there's no guarantee the treatment will be effective for every individual. Study treatments, even standard ones given in a trial, can also carry known risks and side effects. Patients in any clinical trial always have the right to withdraw from the study at any time, for any reason, without it affecting their ongoing medical care.

Locations (83)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • The Oncology Institute of Hope & Innovation
    Verified postcode
    Anaheim, United States
  • University of California Los Angeles
    Verified postcode
    Los Angeles, United States
  • Vanderbilt University Medical Center
    Verified postcode
    Nashville, United States
  • NEXT Virginia
    Verified postcode
    Fairfax, United States
  • Fred Hutchinson Cancer Center
    Verified postcode
    Seattle, United States
  • Icon Cancer Centre Southport
    Verified postcode
    Southport, Australia
  • Monash Medical Centre
    Verified postcode
    Clayton, Australia
  • Universitair Ziekenhuis Antwerpen
    Verified postcode
    Antwerp, Belgium
  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg
    Verified postcode
    Leuven, Belgium
  • Centre Hospitalier Universitaire de Liège
    Verified postcode
    Liège, Belgium
  • Fakultní Nemocnice Hradec Králové
    Verified postcode
    Hradec Králové, Czechia
  • Fakultní Nemocnice Olomouc
    Verified postcode
    Olomouc, Czechia

Common questions

What type of cancer was this study looking at?

This study focused on advanced stomach cancer, including gastric cancer and cancer at the junction of the food pipe and stomach, specifically when it was 'HER2-positive'.

What is Evorpacept (ALX148)?

Evorpacept is an experimental drug designed to work with your body's immune system to fight cancer. It was being tested alongside existing cancer treatments.

Why did the study stop?

The study stopped its larger, later stage (Phase 3) due to strategic business decisions made by the company sponsoring the research. The study is no longer recruiting patients.

Would I have received a placebo in this study?

The Phase 2 part was open-label, meaning everyone knew what treatment they were getting. The planned Phase 3 would have been 'blinded,' meaning some patients might have received a placebo, but that part of the study did not go ahead.

Does this mean Evorpacept isn't a good treatment?

Not necessarily. The decision to stop was for 'strategic considerations,' which are often business-related and don't always reflect how effective or safe the drug is. It just means the company decided not to pursue this particular path for the drug at this time.

How to find out more

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

Discussion

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