Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruiting

Phase I study of 161Tb-PSMA-1 therapy and gallium‑68 gozetotide imaging in adult patients with metastatic clear cell renal cell carcinoma

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on adults with metastatic clear cell renal cell carcinoma, a type of kidney cancer that has spread to other parts of the body. The treatment being tested is a radioactive drug called 161Tb-PSMA-1, which is given by a needle into a vein.

The purpose of the study is to determine the highest dose that can be given safely and the dose that should be used in later studies. This early‑stage, Phase I trial will give participants the drug in several treatment cycles lasting a few weeks each, with regular check‑ups to watch for side effects and to see how the cancer responds.

The drug is delivered intravenous, meaning it goes directly into the bloodstream through a small tube placed in a vein. Participants will stay at the clinic for a short period after each infusion while staff monitor vital signs and any possible reactions. Follow‑up visits will include simple scans and blood tests to track tumor size and overall health, and any problems will be recorded and treated according to standard medical guidelines.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline assessments

    After joining the study, undergo a series of evaluations that include a review of medical history, physical examination, blood and urine tests, and standard imaging scans to document the extent of metastatic clear cell renal cell carcinoma.

  2. Step 2

    Diagnostic imaging with <b>gallium-68 gozetotide</b>

    Receive an intravenous injection of gallium-68 gozetotide at a dose of 2.2 mbq per kilogram of body weight (megabecquerel per kilogram).

    The tracer circulates in the bloodstream and binds to prostate‑specific membrane antigen (psma) on tumor cells, allowing a positron emission tomography (pet) scan to visualize the location and intensity of disease.

    The pet scan results are used to confirm that the cancer expresses psma and is suitable for the subsequent therapeutic infusion.

  3. Step 3

    First therapeutic infusion of <b>161tb‑psma‑1</b>

    Receive a single intravenous infusion of 161tb‑psma‑1 at a fixed dose of 11.5 gbq (gigabecquerel).

    The infusion is administered in a clinical setting under observation; the radioactive compound targets psma‑positive cancer cells and delivers therapeutic radiation.

  4. Step 4

    Monitoring for dose‑limiting toxicities (first 6 weeks)

    Attend scheduled clinic visits weekly for the first six weeks after the therapeutic infusion.

    At each visit, blood tests, urine tests, and symptom assessments are performed to identify any adverse events that could be considered dose‑limiting toxicities, meaning side effects severe enough to limit the amount of drug that can be safely given.

  5. Step 5

    Response evaluation at 24 weeks

    Return for a follow‑up visit approximately 24 weeks after the first infusion.

    Undergo imaging studies (such as ct or pet scans) to assess tumor response, classified as complete response, partial response, stable disease, or progression according to standard criteria.

    The evaluation determines the objective response rate and disease control rate at the 24‑week time point.

  6. Step 6

    Continued follow‑up

    Participate in periodic visits after the 24‑week assessment to monitor overall disease status, progression‑free survival, and overall survival.

    Each visit includes clinical examination, laboratory tests, and imaging as needed until the study concludes or until the patient withdraws.

Who can join the trial?

14 criteria

  • Must be a male or female who is at least 18 years old when signing the consent form.
  • Must be able to understand, sign, and date a written informed consent form before any study procedures.
  • Must have medical insurance coverage.
  • Must be willing and able to attend all study visits and follow the required procedures.
  • Must have a confirmed diagnosis of metastatic clear cell renal cell carcinoma that has gotten worse after at least two previous treatments, including at least one anti‑VEGFR therapy (a drug that blocks blood‑vessel growth to the tumor) and at least one immunotherapy (a medicine that helps the immune system fight cancer).
  • Must have recent imaging that shows the cancer is growing and that the disease can be measured using RECIST v1.1 (a standard way doctors measure tumor size).
  • Must have a positive PSMA‑PET scan (a special imaging test) that meets specific criteria:
    • If cancer is only outside the liver, at least 50% of those lesions must be positive.
    • If cancer is both outside the liver and in the liver, at least 50% of the outside‑liver lesions and at least 80% of liver lesions larger than 1 cm (called supracentimetric) must be positive.
    • If cancer is only in the liver, at least 80% of liver lesions larger than 1 cm must be positive.
    • Must have a life expectancy of at least 6 months.
    • Must have an ECOG performance status of 0‑1 (indicating full activity or slight symptoms) and a Karnofsky Performance Status of 80% or higher (indicating the ability to carry out most daily activities).
    • Must have adequate organ function as shown by laboratory tests (blood work indicating the kidneys, liver, blood cells, etc., are working well).
    • Women who could become pregnant must have a negative pregnancy test and agree to use one highly effective form of contraception from the start of treatment until 6 months after the last dose.
    • Men who are capable of fathering children must also use a highly effective form of contraception during treatment and for 6 months after the final dose.

Who cannot join the trial?

9 criteria

  • Active brain or spinal spread of cancer (including metastases to the central nervous system, epidural space, or leptomeningitis) means you cannot join the study. If you had brain metastases that were treated, you may be allowed only if they have been stable (no growth on scans for at least four weeks), you have no new brain lesions, and you have not taken high‑dose steroids (more than 10 mg per day of methylprednisolone or an equivalent) for at least four weeks.
  • Previous treatment with any radiopharmaceutical (a drug that contains a radioactive element used for imaging or therapy) excludes you from participation.
  • Ongoing side effects from earlier cancer treatments that have not improved to a mild level (grade 1 or lower) prevent entry, except for mild anemia if another specific condition is met. Persistent immune‑related side effects that are more than mild also exclude you, unless they are well‑controlled with replacement therapy (for example, hormone replacement for endocrine problems).
  • Other cancers within the past two years (except for certain skin cancers like basal or squamous cell carcinoma, cervical carcinoma in place, or localized prostate cancer) make you ineligible.
  • History of serious lung scarring or inflammation such as idiopathic pulmonary fibrosis, non‑infectious pneumonitis, interstitial lung disease that needed steroids, current lung inflammation, drug‑induced lung disease, or any active lung inflammation excludes you.
  • Use of prohibited medicines or procedures that are listed in the study’s exclusion table prevents participation.
  • Significant bleeding problems such as noticeable blood in urine, vomit, or cough (more than about half a teaspoon), a history of clotting disorders, or major bleeding events (like lung bleeding) within the last three months disqualify you. If you are on blood‑thinning medication, you can only join if the dose and way you take it have been unchanged for at least two weeks.
  • Active uncontrolled infection (an infection that is not being effectively treated) makes you ineligible.
  • Pregnancy or breastfeeding prevents participation in the trial.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Gallium-68 gozetotide

    is a radioactive substance that is injected into a vein to help doctors see how certain tumors grow and spread. It works with a special type of scan called a PET scan, which creates detailed pictures of the inside of the body. In this study, it is used before the treatment to locate and measure the kidney cancer that has spread to other parts of the body, so the medical team can plan the best approach for therapy.

  • 161Tb-PSMA-1

    is a new therapeutic agent that also goes into the bloodstream. It is designed to find and attach to a protein called PSMA, which is often found on the surface of kidney cancer cells that have spread. Once attached, the radioactive part of the drug delivers targeted radiation directly to the cancer cells, helping to destroy them while limiting damage to healthy tissue. In this trial, patients receive this treatment to determine the safest and most effective amount for future use.

What is already known about the treatment

  • GALLIUM (68GA) GOZETOTIDE

    This medication is given as an intravenous injection and is used for PET scans that help doctors see tumors. It is an approved diagnostic radiopharmaceutical that is widely used in medical literature for imaging cancers that have certain receptors. The substance works by attaching to those receptors and emitting a tiny signal that the scanner detects, allowing the tumor to be located. It belongs to the class of radiopharmaceutical imaging agents.

  • 161Tb-PSMA-1

    This medication is also administered by intravenous injection, but it is designed to treat cancer rather than just show it on scans. It is currently an experimental therapeutic agent being studied in clinical trials for patients with metastatic clear cell renal cell carcinoma. The drug targets a protein called PSMA on cancer cells and delivers radiation from terbium‑161, which damages the cell’s DNA and kills the tumor. It is classified as a radioligand therapy, a type of targeted radiation treatment.

Investigated diseases

Metastatic clear cell renal cell carcinoma - Metastatic clear cell renal cell carcinoma is a type of kidney cancer that originates from the clear cells of the renal tubules. It begins as a primary tumor in the kidney and can spread through the bloodstream or lymphatic system to distant sites such as the lungs, bones, or liver. As the disease advances, the metastatic lesions increase in size and may cause organ‑specific symptoms, while the original kidney tumor may continue to grow.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2026-525526-38-00Protocol codeET26-035Estimated enrolment35 patientsSponsorCentre Leon Berard

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).