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

A first in human Phase 1/2 open-label, multicenter, dose escalation and expansion study of PRS-344/S095012 in patients with solid tumors.

This clinical trial is looking at a new treatment called PRS-344/S095012, given along with an existing medicine called Gazyvaro, for people who have solid tumours. It's an early-stage study, meaning it's one of the first times this new medicine is being tested in people. The main goals are to figure out the safest dose of PRS-344/S095012 and to fully understand any side effects. Researchers will also be checking if the treatment helps to shrink the tumours or stop them from growing. This study is open to both men and women aged 18 and over.

At a glance

Status

Ongoing, recruiting

Phase

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

Sponsor

Institut De Recherches Internationales Servier IRIS

Enrolment target

102

Start

11 Jun 2024

Soild Tumors

What is this study about?

This study is a clinical trial exploring a new potential treatment for people with solid tumours. 'Solid tumours' are growths of abnormal cells in organs like the breast, lung, or bowel. The study is testing a new medicine called PRS-344/S095012 alongside an established treatment called Gazyvaro. Because this is a 'first-in-human' study, it means PRS-344/S095012 is being given to people for the very first time. Researchers will start by carefully increasing the dose to find the safest and most effective amount to give.

The main purpose of this early stage, called Phase 1, is to look closely at safety. This means doctors will be watching for any side effects and seeing how well people tolerate the new medicine. They will also be doing tests like blood work, checking your heart via an ECG, and monitoring your vital signs like blood pressure and pulse. Once a safe dose is found, the study moves into Phase 2, where more people will receive the treatment. In this phase, the focus shifts to seeing how effective the combined treatment is at shrinking or controlling the tumours. They will use scans and other measurements to assess this.

Ultimately, studies like this help us understand if new treatments could become a new option for people living with cancer. The information gathered here will be crucial in deciding if this new medicine should be tested in larger studies in the future. It's a vital step in the long process of developing new medicines.

Key takeaways

This study is testing a new cancer medicine (PRS-344/S095012) for the first time in humans.
It's for people with solid tumours and combines the new medicine with an existing one (Gazyvaro).
The main goals are to find a safe dose and see how well the treatment works.
You would receive treatments as infusions and have regular check-ups.
It's important to understand both potential benefits and risks before deciding to join.

Who may be eligible?

To take part in this study, you must be at least 18 years old. Both men and women are welcome to participate. The study is specifically for people who have been diagnosed with solid tumours.

There might be other specific health requirements or conditions that mean you would not be able to join, even if you meet these general criteria. These details would be discussed fully with you by the study doctor to make sure the trial is right for your individual situation and that it's safe for you to take part.

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 a solid tumour?
Are you willing to have regular clinic visits and tests?
Are you comfortable with receiving medicines through infusions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medicine, PRS-344/S095012, given into your veins (infusion), along with another medicine called Gazyvaro, also given as an infusion. During the study, you would have regular visits to the clinic. These visits would involve various assessments, including physical examinations, blood tests, heart checks (ECGs), and monitoring of your vital signs like blood pressure and pulse. The team would also use scans and photographs to track how your tumour is responding to the treatment.

The study starts by carefully increasing the dose of PRS-344/S095012 to find the safest level. The total duration of your participation would depend on how your body responds to the treatment and your general health, but it would involve ongoing regular monitoring throughout. After stopping the treatment, there would also be follow-up appointments to ensure your well-being.

Potential risks and benefits

Taking part in a clinical trial might offer the potential benefit of accessing a new treatment that isn't yet widely available, which could help your condition. However, it's also important to be aware of potential risks. As this is an early-stage study, the full range of side effects of PRS-344/S095012 is not yet fully known. You might experience side effects from either of the treatments, which could range from mild to more serious. The study team will carefully monitor you for any problems. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual 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
Spain
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Unverified
France
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Unverified
Belgium

Common questions

What are 'solid tumours'?

Solid tumours are abnormal growths or masses of tissue that don't contain liquid, and they can occur in many different parts of the body.

What does 'first-in-human' mean?

It means this is one of the very first times this particular new medicine, PRS-344/S095012, is being tested in people. It has been tested in the lab and in animals before.

What is an 'infusion'?

An infusion is when medicine is given slowly into your bloodstream, usually through a small tube placed in a vein in your arm.

Will I know if the treatment is working?

The study team will be regularly monitoring your condition using scans and other tests. They will discuss your progress with you as the study goes on.

What if I experience side effects?

The study team will closely monitor you for any side effects and will be there to support you. It's important to tell them about anything you feel or notice.