AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

PRadR 2 - A single center, open-label, Phase I study evaluating 161Tb-PSMA therapy in adult patients with metastatic clear cell renal cell carcinoma

This early-stage clinical trial is testing a new type of targeted treatment for adults with advanced clear cell renal cell carcinoma, which is the most common form of kidney cancer. The trial is for patients whose cancer has spread to other parts of the body. The experimental medicine, called 161Tb-PSMA-1, works like a guided missile. It searches for a specific marker on cancer cells and delivers a small dose of radiation directly to them, aiming to destroy the cells while sparing healthy tissue. Before treatment, patients have a specialised scan using a tracer called Gallium-68 to check if their tumours carry this marker. Because this is a Phase I trial, the primary aim is safety. Doctors want to check what side effects occur in the first six weeks and see how well the body handles the medicine.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Centre Leon Berard

Enrolment target

Start

01 Sep 2026

Metastatic clear cell renal cell carcinoma

What is this study about?

Clear cell renal cell carcinoma is the most common type of kidney cancer. When this cancer spreads to other areas of the body, it is known as advanced or metastatic cancer. At this stage, doctors usually offer treatments to help slow down the disease and manage symptoms, but new and more effective options are always needed.

This trial is looking at an innovative approach known as targeted radioligand therapy. The study medicine, 161Tb-PSMA-1, combines a homing molecule with a radioactive particle called Terbium-161. The homing molecule attaches directly to a protein found on the surface of certain cancer cells. Once attached, it delivers radiation straight into the tumour cells to damage or kill them from the inside.

Before receiving the treatment, participants have a special scan using an imaging dye called Gallium-68 gozetotide. This scan lights up on camera if the cancer cells have the right target protein, ensuring the treatment is suitable for each person.

As this is an early-phase trial, researchers are primarily focused on safety. They want to identify any side effects that happen during the first six weeks of care, confirm the safest dose, and monitor how well the treatment keeps the cancer under control over time.

Key takeaways

The trial tests a targeted radiation drug called 161Tb-PSMA-1 for advanced kidney cancer.
A special Gallium-68 scan is used first to see if the cancer has the right target protein.
The main goal is to find out what side effects occur and confirm the treatment is safe.
It is open to adults aged 18 and older whose kidney cancer has spread.
Taking part is voluntary, and you can leave the study at any point.

Who may be eligible?

This trial is designed for adults aged 18 and over who have been diagnosed with clear cell kidney cancer that has spread beyond the kidney. Both men and women can take part.

To be eligible, your cancer must show the specific target protein that the treatment seeks out. Doctors will test for this by giving you a specialised scan before you join the study. If your tumours take up the imaging dye, the treatment may be suitable for you.

Because this is an early study testing drug safety, you will also need to be reasonably active and have kidneys, liver, and bone marrow that are working well enough to handle the treatment safely. Your hospital doctor or trial team will review your full medical history to confirm if this trial is safe and right for you.

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.

I am aged 18 or older.
I have been diagnosed with clear cell renal cell carcinoma (kidney cancer).
My cancer has spread to other parts of my body (metastatic).
I am well enough to attend regular hospital appointments and scans.
I am open to having a screening scan to see if my cancer has the target protein.

Answer every question to see your result.

What does participation involve?

If you decide to join, your care will begin with a screening period. You will have blood tests, health checks, and a specialised Gallium-68 scan to confirm if your tumours are suitable for the therapy. If accepted, you will receive the study drug, 161Tb-PSMA-1, as an injection or drip into a vein.

You will need to visit the hospital regularly, particularly during the first six-week cycle, so the medical team can closely track your health and check for any side effects. These visits will include regular blood samples, physical checks, and symptom reviews. After treatment, you will have follow-up scans at around 24 weeks, and regular check-ups for several months after to see how your body and tumours respond.

Potential risks and benefits

Taking part in this study could potentially help shrink your tumours or slow cancer growth, and the findings will help doctors develop better treatments for future kidney cancer patients. However, because this is an early-phase trial, there is no guarantee that the treatment will improve your condition. There is also a risk of side effects from the targeted radiation, which can include tiredness, nausea, or changes in your blood cell counts. You will be monitored very closely throughout the trial, and you are free to leave the study at any time without giving a reason and without it affecting your standard NHS 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
France

Common questions

What is targeted radiation therapy?

It is a treatment that attaches a small radioactive particle to a molecule that seeks out cancer cells. It acts like a guided tracker, delivering radiation directly into the tumour while trying to protect normal cells.

Will I be radioactive after receiving the medicine?

The medicine contains a small amount of radiation. You may give off tiny amounts of harmless radiation for a short time after treatment. The medical team will give you simple safety guidelines to protect family members and pets.

Is this trial a cure for kidney cancer?

No, this study is not expected to cure advanced kidney cancer. The aim is to see if the medicine is safe and if it can help control the disease and shrink tumours.

What happens if I experience unpleasant side effects?

The study team will check on you constantly. If you have side effects, they can give you medicines to ease them, adjust your schedule, or stop the treatment if it is in your best interest.

Can I leave the study if I change my mind?

Yes. Taking part is completely voluntary. You can choose to stop participating at any point, and your regular doctors will continue to give you the best available standard care.