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Recruiting Phase 2/3 NCT07106762

Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy

Phase 2/3 – combined trial
Conditions: Urothelial Cancer

Sponsor: Bristol-Myers Squibb

trial.available_in: БГ
Overview
A Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer with Disease Progression on or After Immunotherapy
Who can participate
Inclusion Criteria: * Participants must have histologically confirmed advanced urothelial carcinoma. * Participants must be eligible to receive platinum-based chemotherapy. * Participants must be Anti-PD-(L)1-experienced (in locally advanced or metastatic setting), either in combination with or sequential to another systemic therapy. * Participants treated only in the peri-operative setting must have relapsed within 12 months of the last dose of the treatment. * Participants must have ≥ 1 measurable lesion per RECIST v1.1. * Participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1. Exclusion Criteria: * Participants must not have platinum-based chemotherapy exposure within 12 months. * Participants must not have received \>2 prior regimens irrespective of the setting. * Participants must not have prior ADC therapy targeting EGFR or HER3. * Participants must not have prior therapy with topoisomerase 1 inhibitor. * Participants must not have active, untreated brain metastases. * Other protocol-defined inclusion/exclusion criteria apply.
Locations 20
Argentina (1)
Local Institution - 0028
CABA , Buenos Aires
NOT_YET_RECRUITING
Australia (1)
Macquarie University
Macquarie University , New South Wales
Alison Zhang, Site 0149
Belgium (1)
ZAS Augustinus
Wilrijk , Antwerpen
Tom Van den Mooter, Site 0013
Brazil (1)
Local Institution - 0129
Salvador , Estado de Bahia
NOT_YET_RECRUITING
Canada (1)
Local Institution - 0020
Edmonton , Alberta
NOT_YET_RECRUITING
China (1)
Local Institution - 0050
Beijing , Beijing Municipality
NOT_YET_RECRUITING
Czech Republic (1)
Local Institution - 0115
Brno , Brno-město
NOT_YET_RECRUITING
France (1)
Centre Antoine-Lacassagne
Nice , Alpes-Maritimes
Delphine Borchiellini, Site 0009
Germany (1)
NCT
Heidelberg , Baden-Wurttemberg
Stefanie Zschaebitz, Site 0133
Ireland (1)
Local Institution - 0238
Cork
NOT_YET_RECRUITING
Israel (1)
Rabin Medical Center
Petah Tikva , Central District
Victoria Neiman, Site 0096
Italy (1)
A.O.U.C. Policlinico di Bari
Bari , Apulia
Mimma Rizzo, Site 0097
Japan (1)
Local Institution - 0183
Kawasaki , Kanagawa
NOT_YET_RECRUITING
Netherlands (1)
Local Institution - 0036
Breda , North Brabant
NOT_YET_RECRUITING
Norway (1)
Akershus Universitetssykehus
Lørenskog , Akershus
Khanh Vu, Site 0239
Romania (1)
Centrul de Oncologie "Sfântul Nectarie"
Craiova , Dolj
Michael Schenker, Site 0067
Spain (1)
Hospital Universitari Vall d'Hebron
Barcelona , Barcelona [Barcelona]
Rafael Morales Barrera, Site 0221
Sweden (1)
Karolinska Universitetssjukhuset Solna
Solna , Stockholms Län [se-01]
Fernanda Costa Svedman, Site 0235
United Kingdom (1)
Local Institution - 0243
Glasgow , Glasgow City
NOT_YET_RECRUITING
United States (1)
Local Institution - 0167
Gilbert , Arizona
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Phase
Phase 2/3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
30.09.2025
Completion date
18.11.2033
Registry ID
NCT07106762
Source
anzctr
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