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Sacituzumab Govitecan, Preceding Radical Cystectomy, in Treating Patients With Muscle-invasive Bladder Cancer

NCT05226117 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2026-03-27

No results posted yet for this study

Summary

SURE-01 is a neoadjuvant phase 2, open-label, non-randomized, singlecohort study in patients with urothelial carcinoma of the bladder. Patients will be consecutively enrolled and treated. The primary objective of the study is to assess whether sacituzumab govitecan results in pathological complete response (in patients with Muscle-invasive Bladder Cancer who cannot receive or refuse cisplatin-based chemotherapy). Secondary objectives were to evaluate the radiological response of those patients with measurable disease; to evaluate the surgical and medical safety of neoadjuvant therapy; to assess survival outcomes (event-free survival and overall survival).

Conditions

Interventions

DRUG

Sacituzumab govitecan

Sacituzumab govitecan is a humanized monoclonal antibody (mAb) with a hydrolyzable linker through which SN-38 is conjugated to the humanized mAb hRS7 IgG1κ to enhance the delivery of SN-38 to Trop-2- expressing tumors while reducing systemic toxicity. SN-38 is the active metabolite of irinotecan. Sacituzumab govitecan is administered at 7.5 mg/kg as an IV infusion on days 1 and 8 of a 21- day cycle till progression, toxicity or withdrawal of consent

Sponsors & Collaborators

  • High Research

    collaborator OTHER

  • IRCCS San Raffaele

    lead OTHER

Principal Investigators

  • Andrea Necchi, MD · IRCCS San Raffaele

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-23
Primary Completion
2025-09-24
Completion
2025-09-24

Countries

  • Italy

Study Locations

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Entities

Drugs
Diseases

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 NCT05226117 on ClinicalTrials.gov