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

Study of DFF332 alone and in combination with Everolimus or Immuno-oncology therapies in patients with renal cell carcinoma and other selected tumors.

This is an early-stage research study, called a Phase 1 trial, looking into a new medicine called DFF332. Researchers want to see if DFF332 is safe and what effects it has on the body. It will be given alone, or together with other existing cancer treatments like Everolimus or certain immune-boosting therapies. The study is for adults who have a specific type of advanced kidney cancer (Clear Cell Renal Cell Carcinoma) that has returned or spread. This kind of early research is crucial for understanding new treatments and whether they could help people in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Novartis Pharma AG

Enrolment target

Start

11 Jun 2024

Advanced relapsed Clear Cell Renal Cell Carcinoma

What is this study about?

This research is focused on a new potential medicine called DFF332. It's a very early-stage study, often called a 'Phase 1 trial,' which means it's one of the first times this medicine is being given to people. The main goals at this stage are to check if the new medicine is safe to use, find out what dose works best, and understand how it affects the human body.

The study will look at DFF332 by itself, and also when it's given alongside other treatments that are already used for cancer. These might include a medicine called Everolimus, or other therapies that help the body's immune system fight cancer. By testing DFF332 in different ways, researchers hope to learn how effective it might be.

The main condition being studied is a type of advanced kidney cancer called Clear Cell Renal Cell Carcinoma. This study is for people whose cancer has either come back after previous treatment (relapsed) or has spread to other parts of the body. Understanding how new medicines work in these situations is important for developing better treatments for serious illnesses.

Key takeaways

It's an early-stage study (Phase 1) for a new cancer medicine.
The study focuses on a specific type of advanced kidney cancer.
It tests a new medicine called DFF332, alone or with other treatments.
The main goals are to check safety and find the right dose.
Your participation could help advance future cancer treatments.

Who may be eligible?

This study is looking for adult patients, 18 years old or older, who have a specific type of advanced kidney cancer. This type is called 'Clear Cell Renal Cell Carcinoma.'

To be considered for the study, your kidney cancer must have either come back after you've had treatment for it before, or it must have spread to other parts of your body. Both men and women can take part in this research.

There will be other specific health requirements and tests you'd need to meet to ensure your safety and suitability for this particular medicine and study plan. These would be discussed in detail by the study team.

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 Clear Cell Renal Cell Carcinoma?
Has your kidney cancer come back or spread?
Have you discussed this study with your doctor?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a number of tests and checks to make sure the study is suitable for you. These will likely include blood tests, scans, and physical examinations.

Once you are enrolled, you would receive the study medication (DFF332, either alone or with another treatment) according to a specific schedule. This would involve regular visits to the hospital or clinic for your medication, further tests, and to see how you are feeling. The exact number of visits and tests would be clearly explained by the study team.

The study would involve regular follow-up appointments to monitor your health and the effects of the treatment. The total duration of your participation could vary, from several months to potentially longer, depending on how you respond to the treatment and the study's design. You would be fully informed about the expected duration before you agree to participate.

Potential risks and benefits

Taking part in this study could offer some potential benefits. You would receive a new investigational treatment that is not yet widely available, and you would be closely monitored by a dedicated medical team. While there's no guarantee the treatment will work for you, your participation could help researchers learn more and potentially help future patients. However, there are also potential risks. Like all medicines, DFF332 and the other treatments used in this study can have side effects, some of which could be serious or unexpected. The study team would explain all known and potential risks to you before you decide to join. It's very important to remember that participating is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your 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
Czechia
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Unverified
Spain
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Unverified
France

Common questions

What kind of cancer is this study for?

It's for a specific type of advanced kidney cancer called Clear Cell Renal Cell Carcinoma, which has come back or spread.

What does 'Phase 1 trial' mean?

It means this is one of the first times this new medicine is being tested in people. The main aims are to check if it's safe and find the right dose.

Will I get the new medicine by itself or with other treatments?

The study will test the new medicine, DFF332, by itself and in combination with other existing cancer medicines like Everolimus, or immune treatments.

How long would I be in the study if I join?

The length of your participation would depend on how your body responds to the treatment and the study's plan. The study team will give you more details.

Can I leave the study at any time?

Yes, taking part is completely voluntary. You can choose to leave the study at any point, and your regular medical care will not be affected.