Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Randomized, non-comparative, open-label early phase Ib study with OBT076 or OBT076 followed by Balstilimab in patients with Adenoid Cystic Carninoma of the Head and Neck

This early-stage study, called a Phase 1b trial, is looking for people in the UK who have a type of head and neck cancer called Adenoid Cystic Carcinoma. This is for patients whose cancer has returned or spread to other parts of the body (recurrent or metastatic). The main goal is to test the safety of a new medicine called OBT076, given by itself, or OBT076 combined with another medicine called Balstilimab. Because it's an early study, researchers are carefully watching how these medicines affect the body and if they cause any side effects, rather than primarily looking for a cure at this stage. It’s an essential step in understanding if these treatments could be helpful in the future. Participants must be at least 18 years old.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Groupe Oncologie Radiotherapie Tete Cou

Enrolment target

Start

02 Aug 2023

recurrent or metastatic Adenoid Cystic Carcinoma of the Head and Neck

What is this study about?

This study is about a type of cancer called Adenoid Cystic Carcinoma, which affects the head and neck. For some people, this cancer can come back after treatment or spread to other parts of the body. When this happens, doctors are always looking for new and better ways to help.

This particular study is an early-stage trial, also known as a Phase 1b study. This means it's one of the first times these new medicines (called OBT076 and Balstilimab) are being tested in people. The main aim at this stage isn't to look for a cure, but rather to carefully check if the medicines are safe and how the body reacts to them. Researchers want to understand things like how much of the medicine to give and what side effects might occur. Think of it like taking the first careful steps with a new treatment.

Participants in this study will either receive OBT076 on its own, or OBT076 followed by Balstilimab. By studying these treatments carefully in a small group of people, doctors can learn valuable information that could help develop more effective treatments for Adenoid Cystic Carcinoma in the future. This kind of research is crucial for making progress against cancer.

Key takeaways

This is an early-stage study (Phase 1b) for Adenoid Cystic Carcinoma of the Head and Neck.
It's for cancer that has come back or spread.
The main goal is to test the safety of new medicines, OBT076 and Balstilimab.
Participation involves regular hospital visits, tests, and receiving the study medicines.
There are potential benefits and risks, which will be fully explained.
You can withdraw from the study at any time without affecting your care.

Who may be eligible?

This study is looking for adults who are at least 18 years old. Both men and women can take part. The main requirement is that you have a specific type of cancer called Adenoid Cystic Carcinoma of the Head and Neck.

Crucially, your cancer must be either 'recurrent', meaning it has come back after previous treatment, or 'metastatic', which means it has spread from where it started to other parts of your body.

There will be other detailed health checks and requirements that your doctor will discuss with you to make sure the study treatments are safe for you. These criteria are very important for your safety and to ensure the study provides reliable results.

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 at least 18 years old?
Do you have Adenoid Cystic Carcinoma of the Head and Neck?
Has your cancer come back (recurrent) or spread (metastatic)?
Are you able to travel to study appointments?
Are you generally well enough to take part in a study?
Do you understand that participating means receiving an experimental treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have regular visits to the hospital or clinic. These visits will involve various tests to monitor your health, such as blood tests, physical examinations, and possibly scans, to see how your body is reacting to the medicine. You will receive the study medicines, OBT076 (either alone or with Balstilimab), according to a specific schedule decided by the study doctors. The way the medicine is given (e.g., as a drip) and how often will be explained in detail. You'll be closely followed up by the study team throughout the treatment period and for a time afterward, to keep an eye on any side effects and your general well-being. The total length of your participation will be fully explained by the study team.

Potential risks and benefits

Taking part in an early-stage study like this means there's a chance you could potentially benefit from a new treatment that isn't widely available yet, which might help control your cancer. However, it's also important to remember that these are new medicines, and we don't fully know all their effects. There might be side effects, some of which could be serious, and the treatment might not help your cancer. The study team will carefully monitor you for any problems. You will be given full information about all known and potential risks. You always have the right to withdraw from the study at any time, for any reason, without affecting your regular medical care.

Locations (1)

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

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Unverified
France

Common questions

What kind of cancer is Adenoid Cystic Carcinoma of the Head and Neck?

It's a rare type of cancer that usually starts in the glands in the head and neck area.

What does 'recurrent or metastatic' mean?

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

What is a Phase 1b study?

It's an early-stage study to check the safety of new medicines and how they affect the body, rather than how well they treat the cancer at this stage.

What are OBT076 and Balstilimab?

These are the new medicines being tested in the study. They are experimental, meaning they are not yet approved for general use.

Will I get 'new' treatment or a dummy treatment (placebo)?

In this specific study, participants will receive OBT076 either alone or with Balstilimab. There is no placebo arm mentioned.