Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
A database of clinical trials and their results from Australia, New Zealand, and other countries.
account_circle
Log in
to register or update your trial
search
Search for trials
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07106762
Registration number
NCT07106762
Ethics application status
Date submitted
5/08/2025
Date registered
6/08/2025
Date last updated
3/09/2025
Titles & IDs
Public title
Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
EU CTR
Query!
Secondary ID [2]
0
0
CA244-0012
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Urothelial Cancer
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Bladder - transitional cell cancer
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Iza-bren
Treatment: Drugs - Cisplatin
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Carboplatin
Experimental: Arm A -
Experimental: Arm B -
Active comparator: Arm C -
Experimental: Arm D -
Active comparator: Arm E -
Treatment: Drugs: Iza-bren
Specified dose on specified days
Treatment: Drugs: Cisplatin
Specified dose on specified days
Treatment: Drugs: Gemcitabine
Specified dose on specified days
Treatment: Drugs: Carboplatin
Specified dose on specified days
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Phase 2: Recommended Phase 3 Dose (RP3D) of BMS-986507
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Approximately 3 months
Query!
Primary outcome [2]
0
0
Phase 3: Progression-Free Survival (PFS)
Query!
Assessment method [2]
0
0
Assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per blinded independent central review (BICR)
Query!
Timepoint [2]
0
0
Up to 5 years
Query!
Primary outcome [3]
0
0
Phase 3: Overall Survival (OS)
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
Up to 5 years
Query!
Secondary outcome [1]
0
0
Phase 2: Objective Response (OR)
Query!
Assessment method [1]
0
0
Assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator
Query!
Timepoint [1]
0
0
Up to 5 years
Query!
Secondary outcome [2]
0
0
Phase 2: PFS
Query!
Assessment method [2]
0
0
Assessed using RECIST v1.1 by investigator
Query!
Timepoint [2]
0
0
Up to 5 years
Query!
Secondary outcome [3]
0
0
Phase 2: Duration of Response (DOR)
Query!
Assessment method [3]
0
0
Assessed using RECIST v1.1 by investigator
Query!
Timepoint [3]
0
0
Up to 5 years
Query!
Secondary outcome [4]
0
0
Phase 2: Time to Response (TTR)
Query!
Assessment method [4]
0
0
Assessed using RECIST v1.1 by investigator
Query!
Timepoint [4]
0
0
Up to 5 years
Query!
Secondary outcome [5]
0
0
Phase 2: OS
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
Up to 5 years
Query!
Secondary outcome [6]
0
0
Phase 2: Iza-bren antibody-drug conjugate (ADC) concentration
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
Up to 5 years
Query!
Secondary outcome [7]
0
0
Phase 2: Iza-bren total antibody concentration
Query!
Assessment method [7]
0
0
Query!
Timepoint [7]
0
0
Up to 5 years
Query!
Secondary outcome [8]
0
0
Phase 2: Iza-bren Ed-04 payload concentration
Query!
Assessment method [8]
0
0
Query!
Timepoint [8]
0
0
Up to 5 years
Query!
Secondary outcome [9]
0
0
Phase 2: Iza-bren observed concentration at end of infusion (Ceoi)
Query!
Assessment method [9]
0
0
Query!
Timepoint [9]
0
0
Up to 5 years
Query!
Secondary outcome [10]
0
0
Phase 2: Iza-bren trough observed concentration (Ctrough)
Query!
Assessment method [10]
0
0
Query!
Timepoint [10]
0
0
Up to 5 years
Query!
Secondary outcome [11]
0
0
Phase 3: OR
Query!
Assessment method [11]
0
0
As per RECIST v1.1 by BICR
Query!
Timepoint [11]
0
0
Up to 5 years
Query!
Secondary outcome [12]
0
0
Phase 3: DoR
Query!
Assessment method [12]
0
0
As per RECIST v1.1 by BICR
Query!
Timepoint [12]
0
0
Up to 5 years
Query!
Secondary outcome [13]
0
0
Phase 3: TTR
Query!
Assessment method [13]
0
0
As per RECIST v1.1 by BICR
Query!
Timepoint [13]
0
0
Up to 5 years
Query!
Secondary outcome [14]
0
0
Phase 3: Time until definitive deterioration in the EORTC QLQ-C30 Global Health Status/Quality of Life (GHS/QoL) scale
Query!
Assessment method [14]
0
0
Query!
Timepoint [14]
0
0
Up to 5 years
Query!
Eligibility
Key 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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
22/10/2025
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
18/11/2033
Query!
Actual
Query!
Sample size
Target
470
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Query!
Recruitment hospital [1]
0
0
Local Institution - 0149 - Macquarie University
Query!
Recruitment hospital [2]
0
0
Local Institution - 0151 - St Leonards
Query!
Recruitment hospital [3]
0
0
Local Institution - 0150 - Heidelberg
Query!
Recruitment postcode(s) [1]
0
0
2109 - Macquarie University
Query!
Recruitment postcode(s) [2]
0
0
2065 - St Leonards
Query!
Recruitment postcode(s) [3]
0
0
3084 - Heidelberg
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Colorado
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Kentucky
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Maryland
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Massachusetts
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Michigan
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Ohio
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Oregon
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Tennessee
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Texas
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Utah
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Virginia
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Washington
Query!
Country [15]
0
0
Argentina
Query!
State/province [15]
0
0
Buenos Aires
Query!
Country [16]
0
0
Argentina
Query!
State/province [16]
0
0
Buenos Aires F.D.
Query!
Country [17]
0
0
Argentina
Query!
State/province [17]
0
0
Córdoba
Query!
Country [18]
0
0
Argentina
Query!
State/province [18]
0
0
Mendoza
Query!
Country [19]
0
0
Austria
Query!
State/province [19]
0
0
Tyrol
Query!
Country [20]
0
0
Austria
Query!
State/province [20]
0
0
Vienna
Query!
Country [21]
0
0
Belgium
Query!
State/province [21]
0
0
Antwerpen
Query!
Country [22]
0
0
Belgium
Query!
State/province [22]
0
0
Oost-Vlaanderen
Query!
Country [23]
0
0
Belgium
Query!
State/province [23]
0
0
Liège
Query!
Country [24]
0
0
Brazil
Query!
State/province [24]
0
0
Estado de Bahia
Query!
Country [25]
0
0
Brazil
Query!
State/province [25]
0
0
Rio Grande do Sul
Query!
Country [26]
0
0
Brazil
Query!
State/province [26]
0
0
Rio de Janeiro
Query!
Country [27]
0
0
Brazil
Query!
State/province [27]
0
0
São Paulo
Query!
Country [28]
0
0
Canada
Query!
State/province [28]
0
0
Alberta
Query!
Country [29]
0
0
Canada
Query!
State/province [29]
0
0
Ontario
Query!
Country [30]
0
0
Canada
Query!
State/province [30]
0
0
Quebec
Query!
Country [31]
0
0
China
Query!
State/province [31]
0
0
Beijing Municipality
Query!
Country [32]
0
0
China
Query!
State/province [32]
0
0
Fujian
Query!
Country [33]
0
0
China
Query!
State/province [33]
0
0
Guangdong
Query!
Country [34]
0
0
China
Query!
State/province [34]
0
0
Hubei
Query!
Country [35]
0
0
China
Query!
State/province [35]
0
0
Hunan
Query!
Country [36]
0
0
China
Query!
State/province [36]
0
0
Jiangsu
Query!
Country [37]
0
0
China
Query!
State/province [37]
0
0
Shandong
Query!
Country [38]
0
0
China
Query!
State/province [38]
0
0
Shanghai Municipality
Query!
Country [39]
0
0
China
Query!
State/province [39]
0
0
Sichuan
Query!
Country [40]
0
0
China
Query!
State/province [40]
0
0
Tianjin Municipality
Query!
Country [41]
0
0
China
Query!
State/province [41]
0
0
Zhejiang
Query!
Country [42]
0
0
China
Query!
State/province [42]
0
0
Zhengzhou
Query!
Country [43]
0
0
Czechia
Query!
State/province [43]
0
0
Praha 5
Query!
Country [44]
0
0
France
Query!
State/province [44]
0
0
Alpes-Maritimes
Query!
Country [45]
0
0
France
Query!
State/province [45]
0
0
Alsace
Query!
Country [46]
0
0
France
Query!
State/province [46]
0
0
Aquitaine
Query!
Country [47]
0
0
France
Query!
State/province [47]
0
0
Loire-Atlantique
Query!
Country [48]
0
0
France
Query!
State/province [48]
0
0
Provence-Alpes-Côte d'Azur Region
Query!
Country [49]
0
0
France
Query!
State/province [49]
0
0
Puy-de-Dôme
Query!
Country [50]
0
0
France
Query!
State/province [50]
0
0
Rhône-Alpes
Query!
Country [51]
0
0
France
Query!
State/province [51]
0
0
Val-de-Marne
Query!
Country [52]
0
0
France
Query!
State/province [52]
0
0
Paris
Query!
Country [53]
0
0
France
Query!
State/province [53]
0
0
Île-de-France Region
Query!
Country [54]
0
0
Germany
Query!
State/province [54]
0
0
Baden-Wurttemberg
Query!
Country [55]
0
0
Germany
Query!
State/province [55]
0
0
Bavaria
Query!
Country [56]
0
0
Germany
Query!
State/province [56]
0
0
Lower Saxony
Query!
Country [57]
0
0
Germany
Query!
State/province [57]
0
0
Schleswig-Holstein
Query!
Country [58]
0
0
Germany
Query!
State/province [58]
0
0
Thuringia
Query!
Country [59]
0
0
Germany
Query!
State/province [59]
0
0
Berlin
Query!
Country [60]
0
0
Germany
Query!
State/province [60]
0
0
Düsseldorf
Query!
Country [61]
0
0
Germany
Query!
State/province [61]
0
0
Frankfurt
Query!
Country [62]
0
0
Germany
Query!
State/province [62]
0
0
Hamburg
Query!
Country [63]
0
0
Germany
Query!
State/province [63]
0
0
Herne
Query!
Country [64]
0
0
Germany
Query!
State/province [64]
0
0
Ulm
Query!
Country [65]
0
0
Israel
Query!
State/province [65]
0
0
Central District
Query!
Country [66]
0
0
Israel
Query!
State/province [66]
0
0
Jerusalem
Query!
Country [67]
0
0
Israel
Query!
State/province [67]
0
0
Northern District
Query!
Country [68]
0
0
Italy
Query!
State/province [68]
0
0
Apulia
Query!
Country [69]
0
0
Italy
Query!
State/province [69]
0
0
Campania
Query!
Country [70]
0
0
Italy
Query!
State/province [70]
0
0
Liguria
Query!
Country [71]
0
0
Italy
Query!
State/province [71]
0
0
Roma
Query!
Country [72]
0
0
Italy
Query!
State/province [72]
0
0
Tuscany
Query!
Country [73]
0
0
Italy
Query!
State/province [73]
0
0
Veneto
Query!
Country [74]
0
0
Italy
Query!
State/province [74]
0
0
Milan
Query!
Country [75]
0
0
Italy
Query!
State/province [75]
0
0
Parma
Query!
Country [76]
0
0
Japan
Query!
State/province [76]
0
0
Kanagawa
Query!
Country [77]
0
0
Japan
Query!
State/province [77]
0
0
Tokyo
Query!
Country [78]
0
0
Japan
Query!
State/province [78]
0
0
Toyama
Query!
Country [79]
0
0
Netherlands
Query!
State/province [79]
0
0
North Brabant
Query!
Country [80]
0
0
Netherlands
Query!
State/province [80]
0
0
North Holland
Query!
Country [81]
0
0
Netherlands
Query!
State/province [81]
0
0
Provincie Friesland
Query!
Country [82]
0
0
Romania
Query!
State/province [82]
0
0
Dolj
Query!
Country [83]
0
0
Romania
Query!
State/province [83]
0
0
Cluj-Napoca
Query!
Country [84]
0
0
Romania
Query!
State/province [84]
0
0
Ia?i
Query!
Country [85]
0
0
Spain
Query!
State/province [85]
0
0
Valenciana, Comunitat
Query!
Country [86]
0
0
Spain
Query!
State/province [86]
0
0
Badajoz
Query!
Country [87]
0
0
Switzerland
Query!
State/province [87]
0
0
Canton of St. Gallen
Query!
Country [88]
0
0
Switzerland
Query!
State/province [88]
0
0
Canton Ticino
Query!
Country [89]
0
0
Switzerland
Query!
State/province [89]
0
0
Chur
Query!
Country [90]
0
0
Switzerland
Query!
State/province [90]
0
0
Zurich
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Bristol-Myers Squibb
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
A Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer with Disease Progression on or After Immunotherapy
Query!
Trial website
https://clinicaltrials.gov/study/NCT07106762
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Bristol-Myers Squibb
Query!
Address
0
0
Bristol-Myers Squibb
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
8559073286
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
Query!
When will data be available (start and end dates)?
See Plan Description
Query!
Available to whom?
See Plan Description
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT07106762
Download to PDF