A Study of Izalontamab Brengitecan Versus Chemotherapy in Participants With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer Ineligible for Anti-PD(L)1 Drugs (IZABRIGHT-Breast01)

Part of paid clinical trials in Hot Springs, Arkansas.

Sponsor
Bristol-Myers Squibb
Study ID
NCT06926868
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Iza-bren — DRUG
    Specified dose on specified days
  • Nab-paclitaxel — DRUG
    Specified dose on specified days
  • Paclitaxel — DRUG
    Specified dose on specified days
  • Capecitabine — DRUG
    Specified dose on specified days
  • Carboplatin — DRUG
    Specified dose on specified days
  • Gemcitabine — DRUG
    Specified dose on specified days

Study Details

The purpose of this study is to assess the efficacy and safety of iza-bren, a bi-specific antibody-drug conjugate against EGFR and HER3 with a topoisomerase inhibitor payload versus treatment of physician's choice (TPC) (paclitaxel, nab-paclitaxel, carboplatin plus gemcitabine, and capecitabine) for the treatment of first-line metastatic triple-negative breast cancer (TNBC) or estrogen receptor (ER)-low, human epidermal growth factor receptor 2 (HER2)-negative BC patients who are not candidates for anti-PD(L)1 therapy and endocrine therapies.

Key Dates

Start date
Sep 11, 2025
Status verified
Jun 2026
Primary completion
Mar 13, 2028
Completion
May 15, 2030

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A1
  • Experimental: Arm A2
  • Active Comparator: Arm B

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Approximately 31 months from first participant randomization ]

Central Contacts

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
    855-907-3286
    [email protected]
  • First line of the email MUST contain NCT # and Site #.

Locations (46)

FacilityCityStateZIPSite coordinators
Local Institution - 0303Hot SpringsArkansas71913
Site 0303
Helios Clinical ResearchCerritosCalifornia90703
Omkar Marathe, Site 0328
562-693-4477
Local Institution - 0307CerritosCalifornia90703-
Local Institution - 0308CerritosCalifornia90703-
Local Institution - 0309CerritosCalifornia90703-
Local Institution - 0311Long BeachCalifornia90805-
USC/Norris Comprehensive Cancer CenterLos AngelesCalifornia90033
Daphne Stewart, Site 0290
323-865-3906
Valkyrie Clinical TrialsLos AngelesCalifornia90067
David Berz, Site 0283
424-535-1874
USC Norris Oncology/Hematology-Newport BeachNewport BeachCalifornia92663
Daphne Stewart, Site 0353
323-397-5954
Local Institution - 0358StanfordCalifornia94305
Site 0358
Local Institution - 0289AuroraColorado80045
Site 0289
Rocky Mountain Cancer CentersDenverColorado80220
Mabel Mardones, Site 0367
Medical Oncology Hematology Consultants, PANewarkDelaware19713
Jamal Misleh, Site 0304
302-366-1200
Local Institution - 0296Pembroke PinesFlorida33028
Site 0296
Local Institution - 0294AtlantaGeorgia30322-
Northside HospitalAtlantaGeorgia30342
Amelia Zelnak, Site 0357
770-205-5292
Local Institution - 0278ChicagoIllinois60612-
Local Institution - 0280ChicagoIllinois60637
Site 0280
Decatur Memorial HospitalDecaturIllinois62526
James Wade, Site 0275
217-876-6611
Local Institution - 0324O'FallonIllinois62269-
Ochsner Clinic FoundationCovingtonLouisiana70433
Melanie Sheen, Site 0286
504-842-9780
Local Institution - 1035BaltimoreMaryland21201
Site 1035
Dana-Farber Cancer InstituteBostonMassachusetts02215
Sara Tolaney, Site 0287
617-632-5743
Massachusetts General HospitalBostonMassachusetts02114
Neelima Vidula, Site 0288
Henry Ford Cancer- Detroit (Brigitte Harris Cancer Pavilion)DetroitMichigan48202
Rebecca Chacko, Site 0359
313-530-1949
Minnesota Oncology HematologyMaple GroveMinnesota55369
Eric Lander, Site 0313
Local Institution - 0372MinneapolisMinnesota55455
Site 0372
Saint Luke's Cancer InstituteKansas CityMissouri64111
Timothy Pluard, Site 0284
314-747-7992
Local Institution - 0312New YorkNew York10016-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Nour Abuhadra, Site 0279
646-888-4451
Local Institution - 1037SyracuseNew York13210
Site 1037
Clinical Research AllianceWestburyNew York11590
Jonathan Goldberg, Site 0295
914-242-2991
White Plains HospitalWhite PlainsNew York10601
Dan Costin, Site 0285
914-849-7630
Duke Cancer InstituteDurhamNorth Carolina27710
Carey Anders, Site 0276
919-684-0313
Willamette Valley Cancer InstituteEugeneOregon97401
Miho Dougherty, Site 0316
Lehigh Valley Health NetworkAllentownPennsylvania18103
Nicholas Lamparella, Site 0356
610-402-9543
Abramson Cancer Center of The University of PennsylvaniaPhiladelphiaPennsylvania19104
Payal Shah, Site 0310
Local Institution - 0360PittsburghPennsylvania15213-3403
Site 0360
St Francis Cancer CenterGreenvilleSouth Carolina29607
Stephen Dyar, Site 0281
864-603-6327
Texas Oncology - Central/South TexasAustinTexas78705
Alvaro Restrepo, Site 0315
Texas Oncology - West TexasEl PasoTexas79902
Ines Sanchez-Rivera, Site 0368
915-544-6750
Texas Oncology - Northeast TexasFlower MoundTexas75028
Vibha Thomas, Site 0305
303-925-0700
(USOR) Texas OncologyHoustonTexas77024-2843
Dhatri Kodali, Site 0314
555-555-5555
Bon Secours St. Francis Medical CenterMidlothianVirginia23114
William Irvin, Site 0277
Local Institution - 0301RoanokeVirginia24014
Site 0301
Shenandoah Oncology, P.C.WinchesterVirginia22601
William Houck, Site 0302
540-662-1108

Find similar trials in Hot Springs, AR

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Local Institution - 0303· Hot Springs, ARHelios Clinical Research· Cerritos, CALocal Institution - 0307· Cerritos, CALocal Institution - 0308· Cerritos, CALocal Institution - 0309· Cerritos, CALocal Institution - 0311· Long Beach, CA

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