Not yet recruitingRare disease

Study of Sacituzumab Tirumotecan in Patients with Papillary Renal Cell Carcinoma and Variant Histology Urothelial Carcinoma (Rare Genitourinary Tumors)

Verified siteInvestigationalNo placebo

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 looks at two rare cancers of the urinary system: Papillary Renal Cell Carcinoma, a type of kidney cancer, and Variant Histology Urothelial Carcinoma, an uncommon form of bladder cancer. Participants will receive the investigational drug Sacituzumab Tirumotecan, which is given as an intravenous infusion, meaning the medication is delivered through a vein using a drip.

The purpose is to see whether the medicine can shrink the tumors, measured by the proportion of patients whose cancers get smaller, called the objective response rate. Patients will receive the treatment on a regular schedule, undergo imaging scans to check tumor size using standard measurement rules known as RECIST, and will be followed for several months to record how long the tumor control lasts, overall survival, and any side effects. The study also collects information on how the treatment affects daily well‑being, referred to as quality of life, and monitors for any adverse events.

The research process

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

Step 1
First infusion appointment
You will attend the study clinic for the first administration of sacituzumab tirumotecan. the drug is given as an intravenous infusion, which means it is delivered slowly into a vein. the amount you receive is calculated as 4 mg/kg (milligrams per kilogram of body weight). the infusion is performed by trained staff and takes a short period of time.
Step 2
Subsequent infusion visits
You will return to the clinic for additional infusions of sacituzumab tirumotecan according to the study schedule. each infusion uses the same dose of 4 mg/kg and is given by intravenous infusion. the exact interval between visits is set by the trial protocol.
Step 3
Imaging assessments
Periodically you will undergo imaging tests, such as a scan, to evaluate the size of your tumor. the results are measured using recist 1.1 criteria, a standardized method that compares tumor measurements over time to determine if the cancer is shrinking, staying the same, or growing.
Step 4
Quality‑of‑life questionnaires
At designated visits you will be asked to complete questionnaires about your health‑related quality of life. these surveys help the study understand how the treatment affects daily activities and overall well‑being.
Step 5
Safety monitoring
Regular blood tests and clinical examinations will be performed to check for any side effects. any adverse events are recorded and graded using the nci‑ctcae v6.0 system, which classifies side effects from mild to severe.
Step 6
Treatment discontinuation and follow‑up
Treatment may be stopped if the cancer progresses, if side effects become unacceptable, or when the study ends. after discontinuation you will continue to be followed for overall survival, which records the time from the first dose until death from any cause.

Who can join the trial?

15 criteria

Informed consent: You must sign a written form agreeing to take part in the study.
Tumor tissue sample: You need to have a stored piece of your tumor or a recent small surgery (biopsy) from any tumor site that has not been treated with radiation. This sample will be tested for a protein called TROP‑2. No extra pathology review is required.
HIV infection (if you have HIV): Your HIV must be well‑controlled with medicines (called ART). This means a CD4+ T‑cell count of 350 cells/mm³ or higher, a very low amount of virus in your blood (viral load under 50 copies), no serious infections related to AIDS in the past year, and a stable medication regimen for at least 4 weeks. Your HIV medicines must not include strong drugs that affect the enzyme CYP3A4. HIV testing is only needed if you already know you have HIV or local rules require it.
Hepatitis B infection (if you have it): You must have been on antiviral medicine for at least 4 weeks and have an undetectable amount of hepatitis B virus in your blood before you start the study. You must stay on this medicine throughout the trial.
Hepatitis C infection (if you have it): You must have finished curative antiviral treatment at least 4 weeks before randomization and have no detectable hepatitis C virus in your blood at screening.
Male participants who can produce sperm: You must agree not to donate sperm and must use a condom plus another reliable birth‑control method for the whole study period and for at least 120 days after the last dose. If you are already unable to produce sperm (azoospermic), no extra birth‑control is needed.
Female participants (assigned female at birth): You must not be pregnant or breastfeeding. If you could become pregnant, you need a negative pregnancy test before the first dose, must not donate or freeze eggs, and must use a highly effective birth‑control method (or choose to abstain from vaginal sex) during the study and for at least 210 days after the last dose. You also must avoid breastfeeding during the study and for at least 10 days after the last dose.
You must be willing and able to follow all study visits, laboratory tests, and other required procedures.
Diagnosis: You must have a confirmed diagnosis of either metastatic or locally advanced unresectable papillary renal cell carcinoma (pRCC) or variant‑histology urothelial carcinoma (VH‑UC) (including many listed subtypes).
Prior treatment: Your disease must have gotten worse after standard therapies. For pRCC, this means you have already received PD‑1/PD‑L1 drugs or tyrosine‑kinase inhibitors. For VH‑UC, your cancer must have progressed after standard treatment, or there must be no standard option available.
Measurable disease: Your tumor must be measurable on scans according to the criteria called RECIST 1.1, as judged by the local doctor or radiologist.
Age: You must be at least 18 years old at the time you sign the consent form.
ECOG performance status of 0‑1: This means you are fully active (score 0) or able to carry out light work and up‑and‑down activities (score 1).
Any side effects (adverse events) from previous cancer treatments must have improved to mild or baseline levels (grade ≤ 1), except for hair loss or skin color changes, which are allowed.
Adequate organ function: Your blood tests, kidney, liver, and other organ results must be within the safe ranges defined by the study, with samples taken no more than 10 days before you start treatment.

Who cannot join the trial?

17 criteria

Symptomatic brain metastases or leptomeningeal disease: You cannot join if cancer has spread to the brain and is causing symptoms, or if there is cancer affecting the membranes covering the brain and spinal cord, unless the brain lesions have been stable on scans for at least 4 weeks and you have not needed steroid medication for at least 14 days.
Recent systemic anticancer therapy: You must not have received any chemotherapy or other cancer‑directed medicines within 2 weeks before the first study dose.
Recent radiotherapy or radiation side effects: You cannot participate if you had any radiation treatment within 2 weeks before the first dose, if you have lingering radiation‑related side effects that need steroids, or if you have radiation‑induced lung inflammation (radiation pneumonitis). Small palliative radiation for areas outside the brain is allowed if the last session was at least 7 days before the first dose.
Live or live‑attenuated vaccine: Receiving a vaccine that contains a weakened form of a virus or bacteria within 30 days before the first dose disqualifies you. Inactivated (killed) vaccines are permitted.
Strong CYP3A4 inducer or inhibitor: If you are taking a medication that strongly increases or decreases the activity of the liver enzyme CYP3A4 and cannot stop it, you are excluded. Such medicines must be stopped at least 2 weeks before starting the study.
Enrollment in another therapeutic clinical trial: You may not be taking part in any other study that tests a treatment for cancer or that could affect the cancer therapy being studied.
Recent investigational drug or device: Use of any experimental medicine or medical device within 4 weeks before the first dose makes you ineligible.
Severe allergic reaction: A serious (grade 3 or higher) allergy to the study drug, any of its ingredients, or to another biologic medication excludes you.
Recent major surgery or serious injury: Having major surgery or a significant injury within 4 weeks before the first dose, or needing major surgery during the study period, prevents participation. You must have recovered fully from any surgery before starting.
Active infection needing systemic therapy: If you have an infection that requires treatment with medicines that act throughout the body (other than the specific infections allowed in the study), you cannot join.
Severe eye conditions: A history of very dry eye, severe Meibomian gland disease (a problem with the oil glands of the eyelids), severe blepharitis (inflammation of the eyelid margins), or serious corneal disease that would stop or delay healing of the eye surface makes you ineligible.
History or current pneumonitis / interstitial lung disease (ILD): If you have ever had non‑infectious lung inflammation that required steroids, currently have lung inflammation, or have a suspected lung disease that cannot be ruled out by standard tests, you are excluded.
Uncontrolled serious heart or brain‑blood‑vessel disease: This includes advanced heart failure (New York Heart Association Class III or IV), unstable chest pain (angina), recent heart attack, uncontrolled abnormal heart rhythm, a prolonged QT interval on an ECG greater than 480 ms, or any major cardiovascular or cerebrovascular problem within the past 6 months.
Additional active cancer: Having another cancer that is getting worse or that needed active treatment in the past 3 years excludes you, except for certain skin cancers (basal cell, squamous cell, carcinoma in situ) that have been cured, or low‑risk early‑stage prostate cancer meeting specific criteria.
Other condition that could affect the study: Any other medical condition, lab abnormality, or circumstance that the doctor believes could interfere with the study results or your ability to follow the study procedures makes you ineligible.
Prior treatment with a TROP‑2‑targeted antibody‑drug conjugate (ADC): If you have previously received a cancer drug that targets the protein TROP‑2 and is linked to a chemotherapy payload, you cannot participate.
Prior treatment with a topoisomerase 1 inhibitor‑containing ADC: Having received a cancer drug that combines a topoisomerase 1 inhibitor (a type of chemotherapy) with an antibody‑drug conjugate also excludes you.

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

Hospital Universitario 12 De Octubre
Verified
Madrid, Spain

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

Sacituzumab tirumotecan is an experimental medicine that combines an antibody designed to find and bind to a protein called Trop‑2 on cancer cells with a chemotherapy drug that kills those cells. In this study, it is given to patients through an intravenous (IV) infusion, meaning it is delivered directly into a vein over a short period of time. The purpose of using this medicine is to see if it can shrink or stop the growth of rare genitourinary cancers, specifically papillary renal cell carcinoma (pRCC) and very high‑grade urothelial carcinoma (VH‑UC), by measuring how many patients have a reduction in tumor size.

Sacituzumab Tirumotecan

What is already known about the treatment

Sacituzumab Tirumotecan - This medication is given as a solution for injection that is slowly infused into a vein (intravenous infusion). It is currently an investigational drug being studied in a Phase II clinical trial and has not yet received regulatory approval. The treatment is aimed at rare genitourinary cancers, specifically papillary renal cell carcinoma and variant‑histology urothelial carcinoma. It works by using an antibody that seeks out a protein called Trop‑2 on cancer cells and then delivers a chemotherapy payload that blocks the DNA‑cutting enzyme topoisomerase I, stopping cancer cells from dividing. Sacituzumab tirumotecan is classified as an antibody‑drug conjugate, a type of targeted anticancer therapy.

Investigated diseases

Papillary renal cell carcinoma
This is a kidney cancer that forms small, finger‑like growths in the kidney tissue. The tumors usually grow slowly at first, but they can become larger and invade nearby blood vessels. Over time they may spread to regional lymph nodes or distant organs such as the lungs. Patients may notice blood in the urine or flank pain as the disease advances. The cancer’s growth pattern can vary, with some tumors staying confined to the kidney for many years.
Variant histology urothelial carcinoma
This is a bladder cancer that contains unusual cell types different from typical urothelial cells. It tends to grow more aggressively into the bladder wall and can involve the muscle layer early. As it progresses, the tumor may spread to surrounding tissues and distant sites like the lymph nodes. Symptoms often include blood in the urine and urinary urgency. The disease can advance in a stepwise fashion, with new growths appearing in the bladder lining and deeper layers.