AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

FIRST IN HUMAN PHASE 1 DOSE ESCALATION AND EXPANSION CLINICAL TRIAL TO EVALUATE THE SAFETY, PHARMACOKINETICS AND ANTITUMOR ACTIVITY OF INTRAVENOUS AROG4-01 IN PATIENTS WITH ADVANCED SOLID TUMORS.

This is a very early study looking at a new experimental medicine called AROG4-01. It's designed for adults who have advanced solid tumours (cancers that form solid lumps) that have continued to grow despite other treatments. Because it's the very first time this medicine is being used in people, the main goals are to make sure it's safe, find the right dose, and understand how the body handles it. Doctors will also be carefully watching to see if it has any positive effects on the cancer. This kind of early study helps researchers decide if a new medicine should be studied further in larger groups of people.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Applied Research Using Omic Sciences S.L.

Enrolment target

Start

11 Apr 2025

Patients with advanced refractory solid tumors.

What is this study about?

This research study is focused on a brand-new medicine, called AROG4-01. When doctors talk about something being "first in human," it means this is the very first time this particular drug is being given to people. This is a crucial step in developing new treatments, as it helps researchers understand how the medicine behaves in the human body, which can be different from how it acts in lab tests or animal studies.

The main aim of this study is to find out if AROG4-01 is safe for people to take and to learn more about how much of the medicine stays in the body and for how long. Researchers will also be looking to see if the medicine has any effect on slowing down or shrinking advanced solid tumours that have not responded well to other standard treatments. It's like taking a very first look at a new key to see if it might fit a lock that other keys haven't opened.

This kind of early study, often called a Phase 1 trial, is a vital part of medical research. The information gathered helps scientists decide if AROG4-01 is promising enough to continue studying in more people in the future. The hope is that new, more effective treatments can be found for difficult-to-treat cancers.

Key takeaways

This is an early-stage study for a brand new cancer medicine, AROG4-01.
It's for adults with advanced solid tumours that haven't responded to other treatments.
The main goals are to check safety, find the right dose, and see how the body handles the medicine.
Doctors will also look for any signs that the medicine is helping to fight the cancer.
Participation involves regular clinic visits for treatments and close medical monitoring.

Who may be eligible?

This study is looking for adult patients who have advanced solid tumours. "Advanced" means the cancer has spread or is difficult to treat. "Solid tumours" refers to cancers that form a lump, as opposed to blood cancers like leukaemia.

Critically, you would be considered for this study if your cancer has not responded to other standard treatments, or if those treatments are no longer working. You must be at least 18 years old to take part. This study is open to both men and women.

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 a solid tumour (a cancer that forms a lump)?
Has your cancer continued to grow despite other treatments?
Are you willing and able to attend regular clinic appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medicine, AROG4-01, directly into a vein (intravenously). This typically involves regular visits to the clinic for treatments and assessments. During these visits, doctors and nurses will monitor your health very closely. This will likely involve regular blood tests, physical examinations, and scans to see how your body is responding to the medicine and if your cancer is changing. The total duration of your participation would be discussed with you, but early studies often involve frequent check-ups and follow-up care for a period, even after you stop taking the study medicine.

Potential risks and benefits

As this is a very early study, the main potential benefit is that you could be among the first to receive a new medicine that might help your specific cancer, though this is not guaranteed due to the experimental nature of the drug. However, there are also potential risks; since it's a new medicine, not all side effects are known, and some could be serious. You would be closely monitored, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual 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
Spain

Common questions

What does 'first in human' mean?

It means this is the very first time this new medicine is being given to people. Researchers are carefully checking its safety and how it works in the body.

What kind of cancer is this study for?

It's for people with advanced solid tumours, which are cancers that form a lump and have not responded to other treatments.

Is this medicine approved yet?

No, it's an experimental medicine still in the early stages of testing and is not yet approved for general use.

What happens if the medicine doesn't work for me?

The medical team will discuss your options with you. Your health and wellbeing are their priority, and you are free to leave the study at any time.

Will I have to pay to be part of this study?

No, you will not have to pay to receive the study medicine or for the procedures directly related to the research.