NCT07106762Recruiting
Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy
Summary
A Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer with Disease Progression on or After Immunotherapy
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.
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 2 · Phase 3
- Study type
- Interventional
- Countries
- Switzerland, France, Germany, Italy, Austria, United States, Argentina, Australia, Belgium, Brazil, Canada, China, Czechia, Ireland, Israel, Japan, Netherlands, Norway, Romania, Spain, Sweden, United Kingdom
- Sponsor
- Bristol-Myers Squibb(Industry)
- Protocol no.
- CA244-0012
- Conditions
- Urothelial Cancer
- Interventions
- Drug
Treatments studied
- Iza-bren
- Cisplatin
- Gemcitabine
- Carboplatin
Locations · 122
- Sankt Gallen, SwitzerlandCantonal Hospital St.GallenRecruiting at this site
- Bellinzona, SwitzerlandOspedale Regionale Bellinzona e ValliRecruiting at this site
- Chur, SwitzerlandKantonsspital GraubündenRecruiting at this site
- Zurich, SwitzerlandUniversitätsSpital ZürichRecruiting at this site
- Nice, FranceCentre Antoine-LacassagneRecruiting at this site
- Strasbourg, FranceCHU Strasbourg-HautepierreRecruiting at this site
- Bordeaux, FranceCHU de Bordeaux Hop St ANDRERecruiting at this site
- Lyon Cedex08, FranceCentre Leon BerardRecruiting at this site
- Brest, FranceCHRU de BrestRecruiting at this site
- Suresnes, FranceHôpital FochRecruiting at this site
- Saint-Herblain, FranceInstitut de Cancérologie de l'OuestRecruiting at this site
- Clermont-Ferrand, FranceCentre Jean Perrin - Centre Régional de Lutte contre le Cancer d'AuvergneRecruiting at this site
- Villejuif, FranceGustave RoussyRecruiting at this site
- Paris, FranceHôpital Européen Georges PompidouRecruiting at this site
- Paris, FranceGroupe hospitalier Paris saint JosephRecruiting at this site
- Heidelberg, GermanyNCTRecruiting at this site
- Nürtingen, GermanyStudienpraxis UrologieRecruiting at this site
- Munich, GermanyTUM KlinikumRecruiting at this site
- Nuremberg, GermanyKlinikum Nürnberg NordRecruiting at this site
- Regensburg, GermanyCaritas-Krankenhaus St. JosefRecruiting at this site
- Hanover, GermanyMedizinische Hochschule HannoverRecruiting at this site
- Kiel, GermanyUniversitaetsklinikum Schleswig-Holstein Campus KielRecruiting at this site
- Jena, GermanyUniversitätsklinikum JenaRecruiting at this site
- Berlin, GermanyCharité - Universitaetsmedizin Berlin - Campus Bejnamin FranklinRecruiting at this site
- Düsseldorf, GermanyUniversitaetsklinikum DuesseldorfRecruiting at this site
- Frankfurt, GermanyKrankenhaus Nordwest GmbHRecruiting at this site
- Hamburg, GermanyUniversitaetsklinikum Hamburg-EppendorfRecruiting at this site
- Herne, GermanyMarienhospital HerneRecruiting at this site
- Ulm, GermanyUniversitaetsklinikum UlmRecruiting at this site
- Bari, ItalyA.O.U.C. Policlinico di BariRecruiting at this site
In total, worldwide, 122 of the 163 sites listed in the registry are recruiting; the other 41 are not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: July 29, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 92 more locations
Other identifiers
- EU CTR · other identifier
- WHO · other identifier
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.