Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A PHASE 2 STUDY OF ALX148 IN COMBINATION WITH PEMBROLIZUMAB IN PATIENTS WITH ADVANCED HEAD AND NECK SQUAMOUS CELL CARCINOMA (ASPEN-03)

This study, called ASPEN-03, is looking at a new treatment approach for advanced head and neck squamous cell carcinoma (HNSCC) that has spread or come back. Patients will receive two medicines: ALX148 and pembrolizumab (also known as Keytruda). Pembrolizumab is already used to treat some cancers. The main goal is to find out how many patients respond to this combined treatment – meaning their tumours shrink or disappear. Researchers will also check how long the treatment works, how safe it is, and what side effects might occur. This is a Phase 2 study, which means it's an earlier-stage trial testing if the new combination is promising.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Alx Oncology Inc.

Enrolment target

Start

30 Apr 2024

metastatic or unresectable recurrent HNSCC

What is this study about?

This study, called ASPEN-03, is investigating a new treatment for a type of cancer known as head and neck squamous cell carcinoma (HNSCC). This particular study focuses on patients whose cancer has either spread (metastatic), cannot be completely removed by surgery (unresectable), or has come back after previous treatment (recurrent).

The trial is looking at a new drug called ALX148 given together with an established cancer medication known as pembrolizumab (you might know it by the brand name Keytruda). Pembrolizumab works by helping your own immune system fight cancer. Researchers want to see if adding ALX148 to pembrolizumab can make the treatment more effective. They are particularly interested in finding out if this combination can shrink tumours or stop them from growing.

This is a 'Phase 2' study, which means it's an important early step in testing new treatments. In this phase, researchers are trying to understand how well the new combination works, how safe it is, and what side effects patients might experience. The information gathered from this study will help determine if this treatment combination should be studied further in larger trials.

Key takeaways

This study evaluates a new combination treatment for advanced head and neck cancer.
It combines a new drug (ALX148) with an existing immunotherapy (pembrolizumab/Keytruda).
The main aim is to see if the combination shrinks tumours or stops them from growing.
It's a Phase 2 study, focusing on how well it works and potential side effects.
Participation involves regular clinic visits, infusions, and monitoring.

Who may be eligible?

To join this study, people must have advanced head and neck squamous cell carcinoma that has either spread to other parts of the body, can't be removed by surgery, or has come back after previous treatment. They must be at least 18 years old.

There will also be other specific medical checks and tests to make sure that taking part in the study is right and safe for you. For example, doctors will review your general health, past treatments, and certain blood test results.

Quick self-check

Do I have advanced head and neck squamous cell carcinoma?
Has my cancer spread, returned after treatment, or is it not removable by surgery?
Am I at least 18 years old?
Am I generally healthy enough to participate in a clinical trial?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would receive the study drugs, ALX148 and pembrolizumab, through an intravenous (IV) infusion, meaning it goes directly into your bloodstream. The study team will explain the schedule for these infusions. You will have regular appointments at the clinic for check-ups, blood tests, and scans to see how your body is responding to the treatment and to monitor for any side effects. You'll also be asked about your overall health and any symptoms you might have.

The study will also look at how your body handles the ALX148 drug and whether your body makes antibodies against it. The total time you spend in the study will depend on how your cancer responds to the treatment and generally how you are feeling, but there will be a follow-up period after you stop receiving the study drugs.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access new treatments before they are widely available. There's a potential that this combination therapy could help slow down or shrink your cancer. However, as with any medical treatment, there are also potential risks and side effects from the drugs used in the study. These will be fully explained to you before you decide to participate. You will be closely monitored for any problems, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

—
Netherlands
—
Belgium
—
Spain

Common questions

What is head and neck squamous cell carcinoma?

It's a type of cancer that starts in the flat, thin cells (squamous cells) found in the head and neck area, such as the mouth, throat, or voice box.

What is 'advanced' cancer?

Advanced cancer means the cancer has spread to other parts of the body (metastatic) or has returned after previous treatment and cannot be easily removed by surgery.

What is pembrolizumab (Keytruda)?

Pembrolizumab is a type of immunotherapy that helps your body's immune system fight cancer cells. It's already approved for treating some cancers.

What is a Phase 2 study?

Phase 2 studies are early-stage trials that test if a new treatment is effective and safe enough to be studied further in larger groups of people.

Will I know if I'm getting the new drug?

In this study, all participants will receive both ALX148 and pembrolizumab. There isn't a placebo group in this trial.