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Recruiting NCT07106762

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

Phase II / Phase III Interventional Urothelial Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Iza-bren, Cisplatin, Gemcitabine, Carboplatin.
Who it may be relevant to
Registry conditions: Urothelial Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Argentina, Australia, Austria, Belgium +17
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

IZABRIGHT-Bladder01: A Randomized, Open-label, Phase 2/3 Trial of Izalontamab Brengitecan Versus Platinum-based Chemotherapy for Metastatic Urothelial Cancer in Participants With Disease Progression on or After an Immunotherapy-based Treatment

Overview

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

Interventions

  • Drug Iza-bren
    Specified dose on specified days
  • Drug Cisplatin
    Specified dose on specified days
  • Drug Gemcitabine
    Specified dose on specified days
  • Drug Carboplatin
    Specified dose on specified days

Primary outcome measures

  • Phase 2: Recommended Phase 3 Dose (RP3D) of BMS-986507 [Time frame: Approximately 3 months]
  • Phase 3: Progression-Free Survival (PFS) [Time frame: Up to 5 years]
  • Phase 3: Overall Survival (OS) [Time frame: Up to 5 years]
Secondary outcome measures (12)
  • Phase 2: Objective Response (OR) [Time frame: Up to 5 years]
  • Phase 2: PFS [Time frame: Up to 5 years]
  • Phase 2: Duration of Response (DOR) [Time frame: Up to 5 years]
  • Phase 2: Time to Response (TTR) [Time frame: Up to 5 years]
  • Phase 2: OS [Time frame: Up to 5 years]
  • Phase 2: Iza-bren antibody-drug conjugate (ADC) concentration [Time frame: Up to 5 years]
  • Phase 2: Iza-bren total antibody concentration [Time frame: Up to 5 years]
  • Phase 2: Iza-bren Ed-04 payload concentration [Time frame: Up to 5 years]
  • Phase 2: Iza-bren observed concentration at end of infusion (Ceoi) [Time frame: Up to 5 years]
  • Phase 2: Iza-bren trough observed concentration (Ctrough) [Time frame: Up to 5 years]
  • Phase 3: OR [Time frame: Up to 5 years]
  • Phase 3: DoR [Time frame: Up to 5 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 35 centers
  • Local Institution - 0167 — Gilbert
  • Local Institution - 0162 — Fullerton
  • Palo Alto Center-Palo Alto Medical Foundation Research Institute — Palo Alto
  • Sutter Health - Sutter Institute for Medical Research — Sacramento
  • University of California Davis (UC Davis) Comprehensive Cancer Center — Sacramento
  • Pacific Hematology Oncology Associates — San Francisco
  • Sutter Santa Rosa — Santa Rosa
  • Rocky Mountain Cancer Centers, LLP — Denver
  • … and 27 more centers
China · 25 centers
  • Local Institution - 0050 — Beijing
  • Local Institution - 0224 — Beijing
  • Local Institution - 0048 — Fuzhou
  • The First Affiliated Hospital Of Fujian Medical University — Fuzhou
  • Local Institution - 0056 — Xiamen
  • Sun Yat-sen University Cancer Center — Guangzhou
  • The First Affiliated Hospital of Guangzhou Medical University — Guangzhou
  • Zhujiang Hospital — Guangzhou
  • … and 17 more centers
Germany · 14 centers

Center list to be confirmed — check the primary protocol.

France · 12 centers

Center list to be confirmed — check the primary protocol.

Spain · 11 centers

Center list to be confirmed — check the primary protocol.

Italy · 9 centers

Center list to be confirmed — check the primary protocol.

Argentina · 6 centers
  • Instituto Alexander Fleming — Caba
  • Hospital Británico de Buenos Aires — CABA
  • Asociación de Beneficencia Hospital Sirio Libanés — Ciudad Autonoma de Buenos Aires
  • Hospital Italiano de Buenos Aires — ABB
  • IONC Instituto Oncologico de Cordoba - Fundacion Richardet Longo — Córdoba
  • Fundacion Centro Oncologico de Integración Regional — Mendoza
Belgium · 4 centers
  • ZAS Augustinus — Wilrijk
  • AZ Maria Middelares — Ghent
  • UZ Gent — Ghent
  • Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman — Liège
Brazil · 4 centers
  • Local Institution - 0129 — Salvador
  • Local Institution - 0121 — Porto Alegre
  • Local Institution - 0130 — Rio de Janeiro
  • Local Institution - 0124 — São Paulo
Canada · 4 centers
  • Local Institution - 0020 — Edmonton
  • The Ottawa Hospital Cancer Centre — Ottawa
  • Princess Margaret Cancer Centre — Toronto
  • McGill University Health Centre — Montreal
Israel · 4 centers

Center list to be confirmed — check the primary protocol.

Japan · 4 centers

Center list to be confirmed — check the primary protocol.

Switzerland · 4 centers

Center list to be confirmed — check the primary protocol.

United Kingdom · 4 centers

Center list to be confirmed — check the primary protocol.

Australia · 3 centers
  • Macquarie University — Macquarie University
  • GenesisCare North Shore — St Leonards
  • Austin Health — Heidelberg
Austria · 3 centers
  • Medizinische Universität Wien — Vienna
  • Klinik Ottakring — Vienna
  • Medizinische Universitaet Innsbruck — Innsbruck
Czechia · 3 centers

Center list to be confirmed — check the primary protocol.

Netherlands · 3 centers

Center list to be confirmed — check the primary protocol.

Norway · 3 centers

Center list to be confirmed — check the primary protocol.

Romania · 3 centers

Center list to be confirmed — check the primary protocol.

Sweden · 3 centers

Center list to be confirmed — check the primary protocol.

Ireland · 2 centers

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07106762 · CA244-0012 · EU CTR · WHO

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗