Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A study to investigate the safety and tolerability of intravenous QEQ278 in patients with advanced solid tumors

Researchers are conducting a study to learn more about a new medicine called QEQ278. This medicine is for people who have advanced cancer, specifically non-small cell lung cancer, oesophageal squamous cell carcinoma, renal cell carcinoma (a type of kidney cancer), or squamous cell carcinoma of the head and neck. This is a very early-stage study, meaning it's the first time this medicine is being given to humans. The main goals are to find out if the medicine is safe to use and what side effects people might experience. Understanding these things is a crucial first step in developing new treatments. Participants will be carefully monitored throughout the study.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Novartis Pharma AG

Enrolment target

Start

06 Dec 2022

Non-small cell lung cancer Oesophageal squamous cell carcinoma Renal cell carcinoma Squamous cell carcinoma of head and neck

What is this study about?

This study is focused on a new investigational medicine called QEQ278. When we say 'investigational,' it means it's still being tested and is not yet available as a standard treatment. This particular study is a very early stage, often called a 'Phase 1' study. This is the first time the medicine will be given to people, after extensive testing in the laboratory. The main purpose of this initial step is to understand how the body reacts to QEQ278, to see if it's safe, and to identify any potential side effects.

The study is open to people who have advanced forms of certain cancers. These include non-small cell lung cancer, a type of oesophageal cancer, a type of kidney cancer (renal cell carcinoma), and a type of head and neck cancer. Advanced cancer means the cancer has spread from where it started. By studying how QEQ278 works in these patients, researchers hope to gather important information that could help in the development of future cancer treatments.

It's important to remember that because this is an early-stage study, we don't yet know if QEQ278 will be an effective treatment for these cancers. The primary focus right now is to understand safety and how well people can tolerate the medicine. This information is vital before moving on to larger studies that will look more closely at whether the medicine helps to treat the cancer.

Key takeaways

This study is testing a new medicine called QEQ278 for advanced cancers.
It's a very early-stage study, focusing on safety and side effects.
The medicine is given directly into a vein (intravenously).
Eligible conditions include specific types of lung, oesophageal, kidney, and head and neck cancer.
Participants must be 18 years or older; all genders are welcome.

Who may be eligible?

To be considered for this study, you need to be an adult, as participants must be 18 years old or older. There is no upper age limit, meaning older adults are welcome to participate if they meet all other criteria.

This study is open to both men and women, regardless of their gender. The researchers want to get a broad understanding of how this new medicine affects different people.

Beyond these basic requirements, there will be specific health checks and medical conditions that you'll need to meet to ensure your safety in the study. These detailed criteria would be discussed with you by the study team or your doctor.

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?
Do you have advanced non-small cell lung cancer, oesophageal squamous cell carcinoma, renal cell carcinoma, or squamous cell carcinoma of the head and neck?
Are you able to attend regular hospital/clinic visits?
Are you comfortable with receiving medicine through a drip in your arm?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new medicine, QEQ278, which will be given directly into your vein (intravenously). This typically involves regular visits to the hospital or clinic for your medicine and for doctors to carry out various tests.

These tests usually include blood tests, physical examinations, and scans to monitor your health and how the medicine might be affecting you. The study team will explain how often these visits will be and what each visit will involve. While the exact duration of your participation isn't specified, these early-stage studies often involve close monitoring for a period, followed by ongoing check-ups.

Throughout the study, you'll be under the careful supervision of the research team. They will be there to answer your questions and monitor your well-being.

Potential risks and benefits

Because QEQ278 is a new medicine, the potential benefits beyond close medical observation are not yet known. The main goal at this stage is to understand its safety. However, by participating, you would be helping medical research and potentially contributing to new treatments for others in the future. As with any new medicine, there is a risk of side effects, some of which could be serious. The study team will explain all known or potential risks to you. You have the right to withdraw from the study at any time, for any reason, without affecting your current or future medical care.

Locations (5)

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

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Unverified
France
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Unverified
Italy
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Unverified
Germany
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Unverified
Belgium
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Unverified
Spain

Common questions

What does 'advanced solid tumors' mean?

This means cancers that have grown beyond their original location in the body.

What is 'intravenous' administration?

It means the medicine is given directly into a vein, usually in your arm, through a drip.

What does 'Phase I' mean for a study?

It means this is the very first time the new medicine is being given to people. The main focus is on safety and how the body handles the medicine.

Will this medicine cure my cancer?

At this early stage, the study isn't designed to find a cure. Its main purpose is to see if the medicine is safe and identify any side effects.

How long will I be in the study?

The study team will give you a detailed schedule, but these types of studies usually involve regular visits and careful monitoring over a period of time.