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Genitourinary Tumors With Sacituzumab Tirumotecan

NCT07716917 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-07-23

No results posted yet for this study

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

Interventions

DRUG

Sacituzumab Tirumotecan (SKB264)

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.

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • MFAR

    collaborator OTHER

  • Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD

    lead OTHER

Principal Investigators

  • Guillermo de Velasco, M.D.; Ph.D. · Hospital Universitario 12 de Octubre

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2029-10-31
Completion
2029-12-31

Countries

  • Spain

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07716917 on ClinicalTrials.gov