Genitourinary Tumors With Sacituzumab Tirumotecan (NCT07716917) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Genitourinary Tumors With Sacituzumab Tirumotecan
Spain100 participantsStarted 2026-10
Plain-language summary
RINGQUEST is a Phase 2, open-label, single arm, basket, investigator-initiated clinical trial of sacituzumab tirumotecan in patients with:
* Cohort 1: papillary renal carcinoma (pRCC).
* Cohort 2: less frequent bladder tumors such as variant histology urothelial carcinoma (VH-UC). The most common VH-UC are nested, microcystic, micropapillary, lymphoepithelioma-like, plasmacytoid, giant cell, poorly differentiated, lipid-rich, clear cell, sarcomatoid) bladder cancer and non-urothelial bladder cancer of epithelial origin including squamous cell carcinoma and adenocarcinoma (urachal and non-urachal).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The participant provides written informed consent for the study.
. Be willing and able to comply with study procedures, laboratory tests, and other requirements of the study.
. Histologically confirmed diagnosis of metastatic or locally advanced unresectable:
. Disease progression after standard treatment or lack of available standard treatment options:
. Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology.
. Is an individual of any sex/gender and is at least 18 years of age at the time of providing the informed consent.
. Has an eastern cooperative Oncology Group Performance status (ECOG PS) of 0 - 1.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective response rate (ORR)
Timeframe: Throughout the study period, up to 2 years
Trial details
NCT IDNCT07716917
SponsorAlianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD
. Participants who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or baseline (except for alopecia and vitiligo).
Exclusion criteria
. Symptomatic brain metastases or leptomeningeal disease. Note: Participants with previously-treated brain metastases may participate provided they are radiologically stable (ie, without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during study screening, are clinically stable, and have not required steroid treatment for at least 14 days before the first dose of study intervention.
. Has an active infection requiring systemic therapy other than those permitted in the inclusion criteria.
. Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
. Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/interstitial lung disease or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at screening
. Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of cardiac QT interval corrected by Fridericia formula (QTcF) to \>480 ms, and/or other serious cardiovascular and cerebrovascular diseases within 6 months before the first dose of study intervention.
. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
. Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study, interfere with the individual's ability to cooperate with the requirements of the study, or interfere with the individual's participation for the full duration of the study, such that it is not in the best interest of the individual to participate, in the opinion of the treating physician investigator.
. Received prior treatment with a TROP-2-targeted antibody drug conjugate (ADC).