Ongoing, recruitingPhase I and Phase II (Integrated)- First administration to humansInterventional

A Phase I/II, Open-Label, Multi-Center Study of ALE.C04 (anti-Claudin-1 Antibody) as a Single Agent and in Combination with Pembrolizumab (anti-PD-1 antibody) in Adult Patients with Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma

This study is for adults with head and neck cancer that has either returned or spread to other parts of the body. We are looking into a new medicine called ALE.C04. It will be given either on its own or together with another medicine called Pembrolizumab (also known as Keytruda). The main goals of the study are to find out if ALE.C04 is safe, what side effects it might cause, and what is the best dose to give. We also want to see if these medicines can help slow down or shrink the cancer. This is an early-stage study, meaning it's one of the first times this new medicine is being used in people.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Alentis Therapeutics AG

Enrolment target

104

Start

01 Dec 2023

Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma

What is this study about?

This research study is focused on a type of cancer called head and neck squamous cell carcinoma. This is a cancer that can affect areas like your mouth, throat, and voice box. We're specifically looking for people whose cancer has either come back after treatment (recurrent) or has spread to other parts of their body (metastatic).

The main idea behind this study is to test a new medicine, ALE.C04, which works differently from other treatments. We'll be looking at it in two ways: first, on its own (as a single treatment), and then also in combination with an existing cancer drug called Pembrolizumab (you might know this as Keytruda). Pembrolizumab is a type of immunotherapy that helps your own immune system fight cancer.

Because ALE.C04 is a new medicine, this study has two parts, called Phase I and Phase II. In Phase I, our main aim is to make sure the medicine is safe and to find the best dose to give. We'll be carefully watching for any side effects. In Phase II, once safety is established, we'll look more closely at how well the medicine works in shrinking the cancer or stopping it from growing. We'll also be investigating if certain genetic markers in the cancer itself might predict who responds best to the treatment.

Key takeaways

This study is testing a new medicine for head and neck cancer that has come back or spread.
It will check the new medicine, ALE.C04, alone and with an existing drug, Pembrolizumab (Keytruda).
The main goals are to check safety, find the best dose, and see if the treatment helps shrink or control the cancer.
This is an early-stage study, one of the first times this new medicine is being used in people.
Participation involves regular clinic visits, infusions, blood tests, and scans.
You can stop participating in the study at any time.

Who may be eligible?

To join this study, you must be an adult, aged 18 years or older. There is no upper age limit for taking part.

You would be considered if you have head and neck squamous cell carcinoma that has either come back after previous treatment or has spread to other parts of your body. We would need to review your specific medical history to confirm you meet all the criteria for safety and to make sure this is the right study for you.

Both men and women are welcome to participate in this research, as long as they meet the other health requirements.

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.

Are you 18 years old or older?
Have you been diagnosed with head and neck squamous cell carcinoma?
Has your cancer come back after previous treatment, or has it spread to other parts of your body?
Are you generally well enough to participate in a clinical trial?
Are you able to travel to the study clinic for regular appointments?

Answer every question to see your result.

What does participation involve?

If you decide to participate, you will receive either the new medicine ALE.C04 alone, or ALE.C04 combined with Pembrolizumab, through an intravenous (IV) infusion, which means it's given directly into your bloodstream, usually through a vein in your arm. The frequency of these infusions will depend on which part of the study you are in, but they generally happen over several weeks in cycles.

Throughout the study, you will have regular visits to the clinic. During these visits, the study team will carry out various assessments. These include blood tests to check how your body is handling the medicine and to measure drug levels, as well as scans (such as CT or MRI) to see how the cancer is responding. We will also monitor your vital signs (like blood pressure and heart rate) and conduct physical examinations. You'll be asked about any side effects you might experience and to fill out questionnaires about your quality of life.

The total duration of your participation will depend on how you respond to the treatment and whether you experience any unacceptable side effects. While the treatment phase continues as long as you are benefiting, there will also be a follow-up period after treatment ends to monitor your long-term health.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as receiving a new investigational treatment that might help when standard treatments haven't worked or are not suitable. However, new treatments also carry unknown risks, and you might experience side effects that are not yet fully understood. There's no guarantee that the treatment will be effective for you. You are free to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy
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Unverified
Spain
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Unverified
France

Common questions

What is head and neck squamous cell carcinoma?

It's a type of cancer that starts in the flat cells found in the head and neck area, like the mouth, throat, or voice box.

What does 'recurrent or metastatic' mean?

Recurrent means the cancer has come back after treatment. Metastatic means the cancer has spread to other parts of the body.

What is Pembrolizumab (Keytruda)?

It's an existing cancer drug that helps your immune system fight the cancer.

What is a 'Phase I/II' study?

This means it's an early-stage study. Phase I focuses on safety and finding the right dose, while Phase II starts to look at how well the treatment works.

Will I get the new medicine or the combination?

The study will test the new medicine (ALE.C04) both on its own and in combination with Pembrolizumab.