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NCT Number: NCT07106762

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hospital Británico de Buenos Aires, CABA, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Iza-bren

Drug

Specified dose on specified days

Other names: BMS-986507, BL-B01D1, Izalontamab brengitecan

Cisplatin

Drug

Specified dose on specified days

Gemcitabine

Drug

Specified dose on specified days

carboplatin

Drug

Specified dose on specified days

Primary outcomes

  1. Phase 2: Recommended Phase 3 Dose (RP3D) of BMS-986507

    Time frame: Approximately 3 months

  2. Phase 3: Progression-Free Survival (PFS)

    Time frame: Up to 5 years

    Assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per blinded independent central review (BICR)

  3. Phase 3: Overall Survival (OS)

    Time frame: Up to 5 years

Secondary outcomes

  1. Phase 2: Objective Response (OR)

    Time frame: Up to 5 years

    Assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator

  2. Phase 2: PFS

    Time frame: Up to 5 years

    Assessed using RECIST v1.1 by investigator

  3. Phase 2: Duration of Response (DOR)

    Time frame: Up to 5 years

    Assessed using RECIST v1.1 by investigator

  4. Phase 2: Time to Response (TTR)

    Time frame: Up to 5 years

    Assessed using RECIST v1.1 by investigator

  5. Phase 2: OS

    Time frame: Up to 5 years

  6. Phase 2: Iza-bren antibody-drug conjugate (ADC) concentration

    Time frame: Up to 5 years

  7. Phase 2: Iza-bren total antibody concentration

    Time frame: Up to 5 years

  8. Phase 2: Iza-bren Ed-04 payload concentration

    Time frame: Up to 5 years

  9. Phase 2: Iza-bren observed concentration at end of infusion (Ceoi)

    Time frame: Up to 5 years

  10. Phase 2: Iza-bren trough observed concentration (Ctrough)

    Time frame: Up to 5 years

  11. Phase 3: OR

    Time frame: Up to 5 years

    As per RECIST v1.1 by BICR

  12. Phase 3: DoR

    Time frame: Up to 5 years

    As per RECIST v1.1 by BICR

  13. Phase 3: TTR

    Time frame: Up to 5 years

    As per RECIST v1.1 by BICR

  14. Phase 3: Time until definitive deterioration in the EORTC QLQ-C30 Global Health Status/Quality of Life (GHS/QoL) scale

    Time frame: Up to 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2029
Study completion
2033
First posted
Aug 6, 2025
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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