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Papillary Renal CarcinomaPhase 2RINGQUESTNCT07716917

Genitourinary Tumors With Sacituzumab Tirumotecan

A Phase 2 study testing Sacituzumab Tirumotecan (SKB264) in people with Papillary Renal Carcinoma and Variant Histology Urothelial Carcinoma, run by Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD at 1 site in Spain.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sacituzumab Tirumotecan (SKB264)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteSpain
Study dates
Oct 2026to Dec 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed Consent
  • 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.
  • Disease Characteristics
  • Histologically confirmed diagnosis of metastatic or locally advanced unresectable:
  • Cohort 1: papillary renal carcinoma (pRCC).
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  • Cohort 2: variant histology urothelial carcinoma (VH-UC) including the following subtypes:
  • 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).
  • Note: Variant histology tumors and non-urothelial tumors of ureter, urethra, urachus, or renal pelvis are included.
  • Note: Patients with mixed cell type are eligible if the predominant histology (over 50%) is variant or non-urothelial. All histological classifications will follow the 2022 world health organization (WHO) Classifications.
  • Disease progression after standard treatment or lack of available standard treatment options:
  • Cohort 1: Prior treatment with PD-1/PD-L1 and or tyrosine kinase inhibitors (TKIs)
  • Cohort 2: Disease progression after standard treatment. Some VH such as micropapillary, small cell, and sarcomatoid variants are considered highly aggressive and no standard treatments are clearly defined, being considered an orphan disease, so they might be included in the first line in case of lack of available standard treatment options.
  • Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology.
  • Note: Lesions situated in a previously-irradiated area are considered measurable if progression has been shown in such lesions.
  • Demographics
  • Is an individual of any sex/gender and is at least 18 years of age at the time of providing the informed consent.
  • Patient Status
  • Has an eastern cooperative Oncology Group Performance status (ECOG PS) of 0 - 1.
  • Participants who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or baseline (except for alopecia and vitiligo).
  • Note: Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy are eligible.
  • Adequate organ function. Specimens must be collected within 10 days before the start of study intervention:
  • absolute neutrophil count (ANC) ≥1500/µL Platelets ≥100,000/µL Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L Measured or calculated creatinine clearance (CrCl) ≥30 mL/min Total bilirubin ≤1.5 × upper limit normal (ULN) OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN aspartate aminotransferase (AST, SGOT) and alanine aminotransferase (ALT, SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases) Albumin ≥3.0 g/dL international normalized ratio (INR) or prothrombin time (PT) / activated patial thromboplastin (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
  • without colony-stimulating factors, erythropoietin dependency, and without packed red blood cell (pRBC) transfusion within the preceding 2 weeks.
  • without albumin supplementation within the last 72 hours.
  • Has provided an archival tumor tissue sample or most recently obtained core, incisional, or excisional biopsy of a tumor lesion from any site (primary or metastasis) not previously irradiated. Sites should follow local guidelines regarding fresh tissue collection. Tissue is required for determination of TROP-2 status by the central laboratory. No central pathological review and TROP-2 expression level assessment will be needed to include the patient in the trial.
  • HIV-infected participants must have well-controlled HIV on antirretroviral therapy (ART), defined as:
  • Having a CD4+ T-cell count ≥350 cells/mm3 at the time of screening
  • Having achieved and maintained virologic suppression, defined as confirmed HIV RNA level below 50 or the lower limit of quantification using the locally available assay, at the time of screening and for at least 12 weeks before screening
  • Absence of any AIDS-defining opportunistic infections within the past 12 months
  • Being on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before randomization and agreeing to continue ART throughout the study Note: The ART regimen must not contain any antiretroviral medications that are strong CYP3A4 inducers/inhibitors/substrates.
  • HIV testing at screening is not required unless:
  • There is a known history of HIV infection Mandated by local guidelines
  • Participants who are HBsAg positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load before randomization.
  • Note: Participants should remain on antiviral therapy throughout study intervention and follow local guidelines for HBV antiviral therapy post completion of study intervention.
  • Hepatitis B testing at screening is not required unless: There is a known history of HBV infection Mandated by local guidelines
  • Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.
  • Note: Participants must have completed curative antiviral therapy at least 4 weeks before randomization.
  • Hepatitis C testing at screening is not required unless: There is a known history of HCV infection Mandated by local guidelines
  • Male Participants
  • If capable of producing sperm, the participant agrees to the following during the intervention period and for at least 120 days after the last dose of sacituzumab tirumotecan:
  • Refrains from donating sperm.
  • Uses a penile/external condom when having penile-vaginal intercourse with a nonparticipant of childbearing potential who is not currently pregnant plus partner use of an additional contraceptive method, as a condom may break or leak.
  • Note: If the participant is azoospermic (vasectomized or secondary to medical cause, documented from the site personnel's review of the participant's medical records, medical examination, or medical history interview), no contraception is required.
  • Female Participants
  • A participant assigned female sex at birth is eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies:
  • Is not a women of childbearing potential (WOCBP) OR
  • Is a WOCBP and:
  • Has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention. If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
  • Medical history, menstrual history, and recent sexual activity has been reviewed by the physician investigator to decrease the risk for inclusion of a WOCBP with an early undetected pregnancy.
  • The participant agrees not to donate eggs (ova, oocytes) to others or freeze/store eggs during this period for the purpose of reproduction.
  • Uses a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency, or is abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) during the intervention period and for at least 210 days after the last dose of sacituzumab tirumotecan.
  • Note: The physician investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention. Contraceptive use by WOCBPs should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions are more stringent than the requirements above, the local label requirements are to be followed.
  • Abstains from breastfeeding during the study intervention period and for at least 10 days after study intervention.

Who cannot join

  • Medical Conditions
  • 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.
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  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
  • Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (excluding carcinoma in situ of the bladder) who have undergone potentially curative resection are not excluded.
  • Note: Participants with low-risk early-stage prostate cancer (T1-T2a, Gleason score ≤6, and prostate specific antigen <10 ng/mL) either treated with definitive intent or untreated in active surveillance with stable disease are not excluded.
  • 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.
  • Prior/Concomitant Therapy
  • Received prior treatment with a TROP-2-targeted antibody drug conjugate (ADC).
  • Received prior treatment with a topoisomerase 1 inhibitor-containing ADC.
  • Received prior systemic anticancer therapy within 2 weeks before the first dose of study intervention.
  • Received prior radiotherapy within 2 weeks before the first dose of study intervention, has radiation-related toxicities, requiring corticosteroids, and/or has had radiation pneumonitis.
  • Note: Two weeks or fewer of palliative radiotherapy for non-central nervous system disease is permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention.
  • Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
  • Is currently receiving a strong inducer/inhibitor of CYP3A4 that cannot be discontinued for the duration of treatment with study intervention. The required washout period before starting study intervention is 2 weeks.
  • Prior/Concurrent Clinical Study Experience
  • Is currently enrolled on another therapeutic clinical trial. Concurrent enrollment on another therapeutic clinical trial or any trial designed to impact the efficacy of anti-cancer therapy is prohibited.
  • Has received an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.
  • Other Exclusions
  • Severe hypersensitivity (Grades ≥3) to study intervention, any of their excipients, and/or to another biologic therapy.
  • Has had major surgery or significant traumatic injury within 4 weeks before the first dose of study intervention. Anticipation of the need for major surgery during the course of treatment with study intervention is also exclusionary.
  • Note: Participants who underwent major surgery must have adequately recovered from toxicity and/or complications from the surgery before starting study intervention.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

GUARD Secretary contact

0034933931838

info@guardconsortium.org

Spain1 site

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, 28041

    A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net

    A Principal Investigator designed by the Sponsor, M.D.; Ph.D.

Other trials in Spain

About this study

Official title: RINGQUEST: Exploring Understudied Genitourinary Tumors With Sacituzumab Tirumotecan; a Single-arm, Basket, Phase II Study

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).
Read the detailed description

The study aim to evaluate the efficacy of Sacituzumab Tirumotecan in patients with rare genitourinary tumors: pRCC and VH-UC by means of objective response rate (ORR) according to RECIST 1.1 criteria.

The trial will follow a Simon two-stage design to enroll competitively up to 100 patients, 50 pRCC and 50 VH-UC. The study will enroll the first 15 patients within each cohort 1 and 2, respectively, and monitor for responses. If the interim analysis surpasses the futility threshold (4 or more tumor responses) in any cohort, that cohort will be expanded up to the total expected patients.

All patients will undergo periodic tumor assessments by CT or MRI scan at screening, cycle 4 day 1, cycle 8 day 1, cicle 12 day 1 and every 12 weeks ± 14 days (3 months) thereafter until progression or patient withdrawal. Further CT/MRI scans could be performed upon suspicion of disease progression according to standard clinical practice and physician criteria. Safety safety (AEs, comorbidities) will be assessed at every visit through continuous monitoring of signs and symptoms and periodic laboratory analysis. The study also includes the assessment of patient reported outcomes regarding quality of life (QoL) that will be assessed through the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30).

Additionally, Trophoblast cell surface antigen 2 (TROP-2) expression levels and tumor mutations and genetic alterations will be centrally reviewed in tumor biopsies or archival tumor tissue obtained as close as possible to the baseline.

The study includes an exploratory genomic, transcriptomic, and immune-microenvironment characterization analyses that will map responders versus non-responders.

Being tested
Sacituzumab Tirumotecan (SKB264)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sacituzumab Tirumotecan (SKB264)Drug

    Sacituzumab tirumotecan will be administered by IV infusion on Days 1 of each 2-week cycle.

    There is a maximum duration of exposure for sacituzumab tirumotecan of 78 doses (approximately 3 years). Treatment may be prematurely terminated in case of disease progression, unacceptable toxicity, consent withdrawal, or physician criteria.

Study groups in NCT07716917
Study groupRoleWhat they receive
Cohort 1: papillary renal carcinoma (pRCC)ExperimentalPatients with pRCC will be included in this group. All patients are allocated to same intervention (sacituzumab tirumotecan), regardless of the cohort
Receives: Drug: Sacituzumab Tirumotecan (SKB264)
Cohort 2: variant histology urothelial carcinoma (VH-UC)ExperimentalPatients with VH-UC will be included in this group. All patients are allocated to same intervention (sacituzumab tirumotecan), regardless of the cohort
Receives: Drug: Sacituzumab Tirumotecan (SKB264)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR)

    Assessed by the investigator through imaging follow-up (CT scan/MRI) using Response evaluation criteria in solid tumors (RECIST) version 1.1. This will be considered as the percentage of patients with confirmed complete response (CR) or partial response (PR) as their overall best response throughout the study period.

    Measured: Throughout the study period, up to 2 years

Secondary outcomes (5)

  1. Duration of response (DoR)

    Time from the first response (complete response [CR] or partial response [PR]) documentation to the date of the documented progressive disease (PD) as determined using RECIST 1.1 criteria or death due to any cause, whichever occurs first. DoR will be summarized using Kaplan-Meier method.

    Measured: Throughout the study period, up to 2 years

  2. Progression-free survival (PFS)

    Time from first dosing date to the date of confirmed PD according to RECIST 1.1. Patients alive and free of events at the date of the analysis will be censored at their last known tumor assessment. Patients who start a new treatment line without progression will be censored on the date of first dose of the subsequent anticancer treatment.

    PFS will be summarized using Kaplan-Meier method.

    Measured: Throughout the study period, up to 2 years

  3. Overall survival (OS)

    defined as the time elapsed from the first dose of study treatment until death from any cause. Survival will be assessed by recording patient status at each visit. OS will be summarized using Kaplan-Meier method.

    Measured: Throughout the study period, up to 2 years

  4. Patient reported health-related quality of life (HRQoL)

    assessed through the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30), version 3. This is a standard guide with 30 recommendations designed to assess the health of cancer patients. Different scales are measured, including Global Health and Quality of Life, Functional Aspects, and Symptom Scales. The results for each dimension are linearly transformed to generate scores ranging from 0 to 100.

    Here we will report the total score:

    The top of the scale (100) represents "The best health you can imagine." The bottom of the scale (0) represents "The worst health you can imagine."

    Measured: Throughout the study period, up to 2 years

  5. Proportion of adverse events leading to treatment discontinuation

    Defined as the percentage of patients who experience AEs leading to temporary or permanent treatment discontinuation

    Measured: Throughout the study period, up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionOct 2029 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Basket, Phase II Study
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07716917
Sponsor's protocol ID
SC 2025-01
Other IDs
2026-526048-10-00
Acronym
RINGQUEST
Status last verified
Jul 2026
First submitted
16 Jul 2026
Last updated
23 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sacituzumab Tirumotecan (SKB264) in people with Papillary Renal Carcinoma and Variant Histology Urothelial Carcinoma, run by Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 54 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact GUARD Secretary (0034933931838, info@guardconsortium.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: Throughout the study period, up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07716917.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.

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