AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

A Phase I study to evaluate the safety and efficacy of L19IL2 in combination with ruxolitinib in patients with advanced solid tumors.

This study is an early-stage clinical trial (Phase I) looking into a new treatment approach for adults with specific advanced cancers. These include advanced kidney cancer (clear cell renal carcinoma), a type of advanced bowel cancer (colorectal carcinoma that doesn't have a specific BRAF gene change), and advanced pancreatic cancer. The study combines a medicine called L19IL2 with another medicine called ruxolitinib. Researchers want to understand if this new combination is safe for patients and how effective it might be in treating these cancers. This type of study focuses on finding the right dose and checking for side effects.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Philogen S.p.A.

Enrolment target

Start

22 Dec 2025

Advanced solid tumors specifically: • metastatic clear cell renal carcinoma • proficient mismatch repair / microsatellite stable (pMMR/MSS)BRAF-V600E-mutant negative colorectal carcinoma • locally advanced or metastatic pancreatic adenocarcinoma

What is this study about?

This study is an early-stage clinical trial, which means it's one of the first times this new combination of treatments is being tested in people. The main goal is to see if combining two medicines, L19IL2 and ruxolitinib, is safe for patients and to find the best way to give them. Researchers will also be looking to see if this new combination shows any promise in helping to treat certain advanced cancers.

The specific cancers this study is focusing on are a type of advanced kidney cancer called metastatic clear cell renal carcinoma, a particular kind of advanced bowel cancer (colorectal carcinoma), and advanced pancreatic cancer. For the bowel cancer, it's for those with a specific genetic profile. The hope is that this new combination might offer a different way to fight these diseases.

Because this is an early-stage study, it's mainly about understanding the safety and how the drugs work in the body, rather than comparing them to existing treatments. This kind of research is vital for developing new ways to treat cancer in the future.

Key takeaways

This is an early-stage study for specific advanced cancers.
It combines two new medicines, L19IL2 and ruxolitinib.
The main goals are to check treatment safety and find the right dose.
It targets kidney, bowel, and pancreatic cancers with specific features.
Participation involves regular clinic visits, tests, and follow-up.
You have the right to leave the study at any time.

Who may be eligible?

To join this study, you must be an adult, 18 years old or older, with a diagnosis of a specific type of advanced cancer. This includes certain types of advanced kidney cancer, a particular advanced bowel cancer (that doesn't have a BRAF-V600E gene change), or advanced pancreatic cancer.

Both men and women can take part in this study. The medical team will check other health factors to make sure that taking part in the trial is safe and appropriate for you. They will review your medical history and current health condition carefully.

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 kidney cancer (clear cell type)?
Or do you have an advanced form of bowel cancer without the BRAF-V600E gene change?
Or do you have advanced pancreatic cancer?
Are you able to attend regular clinic appointments and undergo scheduled tests?
Are you willing to potentially receive new, experimental treatments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the combination of L19IL2 and ruxolitinib as directed by the study doctors. The exact number of visits, tests, and how often you receive the medication will be explained in detail by the study team. These visits will involve regular check-ups, blood tests, and scans to monitor your health, how the treatment is affecting you, and to see if the treatment is working. There will also be follow-up appointments after you finish the main treatment period to keep an eye on your progress and any long-term effects. The total length of your participation will vary but will be clearly explained before you join.

Potential risks and benefits

Potential benefits of joining this study include receiving new, experimental treatments that might help your condition, which aren't yet available outside of clinical trials. You would also be contributing to medical research that could help others in the future. However, as with all treatments, there are potential risks and side effects. These investigational drugs may cause side effects that are not yet fully known. The study team will explain all known and potential side effects in detail. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (1)

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

—
Unverified
Italy

Common questions

What does 'advanced solid tumors' mean?

It means the cancer has grown and spread from where it started to other parts of your body, and it affects solid organs, not blood.

What is a Phase I study?

A Phase I study is the first step where a new treatment is tested in people. Its main aim is to check if the treatment is safe and to find the best dose, rather than how well it works.

Will I get a placebo (dummy treatment)?

In this specific Phase I study, generally, participants would receive the active study drugs, not a placebo, as the aim is to check safety and dosing of the new combination.

How long will I be in the study?

The exact duration can vary, based on how you respond to treatment and the study plan. The study team will tell you the expected length of your involvement when you discuss joining.

Can I continue with my regular doctor?

Yes, you would continue to be under the care of your regular medical team. The study doctors will work with them to ensure your care is well coordinated.