Genitourinary Tumors With Sacituzumab Tirumotecan

NCT07716917 | Not Yet Recruiting Phase 2

• 2 other identifiers: SC 2025-012026-526048-10-00
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Papillary Renal Carcinoma; Variant Histology Urothelial Carcinoma

Outcome Measures

Primary Outcomes (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.

  Throughout the study period, up to 2 years

Secondary Outcomes (5)

• Duration of response (DoR)

  Throughout the study period, up to 2 years

• Progression-free survival (PFS)

  Throughout the study period, up to 2 years

• Overall survival (OS)

  Throughout the study period, up to 2 years

• Patient reported health-related quality of life (HRQoL)

  Throughout the study period, up to 2 years

• Proportion of adverse events leading to treatment discontinuation

  Throughout the study period, up to 2 years

Study Arms (2)

Cohort 1: papillary renal carcinoma (pRCC)

EXPERIMENTAL

Patients with pRCC will be included in this group. All patients are allocated to same intervention (sacituzumab tirumotecan), regardless of the cohort

Drug: Sacituzumab Tirumotecan (SKB264)

Cohort 2: variant histology urothelial carcinoma (VH-UC)

EXPERIMENTAL

Patients with VH-UC will be included in this group. All patients are allocated to same intervention (sacituzumab tirumotecan), regardless of the cohort

Drug: Sacituzumab Tirumotecan (SKB264)

Interventions

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.

Cohort 1: papillary renal carcinoma (pRCC); Cohort 2: variant histology urothelial carcinoma (VH-UC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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 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.
• 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.

Sponsors & Collaborators

• Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD: lead
• Merck Sharp & Dohme LLC: collaborator
• MFAR: collaborator

Study Sites (1)

Hospital Universitario 12 de Octubre

Madrid, Madrid, 28041, Spain

Location

Study Officials

• Guillermo de Velasco, M.D.; Ph.D.

  Hospital Universitario 12 de Octubre

  STUDY CHAIR

Central Study Contacts

GUARD Secretary

CONTACT

0034933931838; info@guardconsortium.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Basket, Phase II Study

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 21, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)