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)

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

500

Participants

Timeline

Start Date

September 11, 2025

Primary Completion Date

March 13, 2028

Study Completion Date

May 15, 2030

Conditions
Breast Neoplasms
Interventions
DRUG

Iza-bren

Specified dose on specified days

DRUG

Nab-paclitaxel

Specified dose on specified days

DRUG

Paclitaxel

Specified dose on specified days

DRUG

Capecitabine

Specified dose on specified days

DRUG

Carboplatin

Specified dose on specified days

DRUG

Gemcitabine

Specified dose on specified days

Trial Locations (260)

0

NOT_YET_RECRUITING

Local Institution - 0319, Abu Dhabi

1011

RECRUITING

CHUV (centre hospitalier universitaire vaudois), Lausanne

1090

NOT_YET_RECRUITING

Local Institution - 0269, Vienna

1122

NOT_YET_RECRUITING

Local Institution - 0345, Buenos Aires

1181

NOT_YET_RECRUITING

Local Institution - 0214, ABB

1280

NOT_YET_RECRUITING

Local Institution - 0011, Ciudad Autónoma de Buenos Aires

1426

RECRUITING

Instituto Alexander Fleming, Buenos Aires

NOT_YET_RECRUITING

Local Institution - 0317, Buenos Aires

1430

NOT_YET_RECRUITING

Local Institution - 0346, Buenos Aires

2000

RECRUITING

Sanatorio Plaza, Rosario

2013

NOT_YET_RECRUITING

Local Institution - 0340, Soweto

2109

NOT_YET_RECRUITING

Local Institution - 0170, Macquarie University

2193

NOT_YET_RECRUITING

Local Institution - 0342, Parktown

3000

NOT_YET_RECRUITING

Local Institution - 0274, Melbourne

3084

NOT_YET_RECRUITING

Local Institution - 0031, Heidelberg

3100

NOT_YET_RECRUITING

Local Institution - 0270, Sankt Pölten

3350

RECRUITING

Grampians Health, Ballarat Central

4029

NOT_YET_RECRUITING

Local Institution - 0035, Brisbane

5020

NOT_YET_RECRUITING

Local Institution - 0267, Salzburg

5241

NOT_YET_RECRUITING

Local Institution - 0351, East London

5500

NOT_YET_RECRUITING

Local Institution - 0348, Mendoza

6008

RECRUITING

St. John of God Subiaco Hospital, Subiaco

6020

NOT_YET_RECRUITING

Local Institution - 0268, Innsbruck

8008

RECRUITING

Brust-Zentrum, Zurich

8036

NOT_YET_RECRUITING

Local Institution - 0292, Graz

9007

RECRUITING

Cantonal Hospital St.Gallen, Sankt Gallen

10016

WITHDRAWN

Local Institution - 0312, New York

10021

NOT_YET_RECRUITING

Local Institution - 0279, New York

10117

NOT_YET_RECRUITING

Local Institution - 0261, Berlin

10408

NOT_YET_RECRUITING

Local Institution - 0066, Goyang-si

10601

RECRUITING

White Plains Hospital, White Plains

10967

NOT_YET_RECRUITING

Local Institution - 0260, Berlin

11001

NOT_YET_RECRUITING

Local Institution - 0323, Abu Dhabi

11590

RECRUITING

Clinical Research Alliance, Westbury

13273

NOT_YET_RECRUITING

Local Institution - 0093, Marseille

13620

NOT_YET_RECRUITING

Local Institution - 0067, Seongnam

14070

NOT_YET_RECRUITING

Local Institution - 0329, Mexico City

15006

NOT_YET_RECRUITING

Local Institution - 0105, A Coruña

15258

NOT_YET_RECRUITING

Local Institution - 0322, Al Ain City

16132

NOT_YET_RECRUITING

Local Institution - 0054, Genoa

18103

NOT_YET_RECRUITING

Local Institution - 0356, Allentown

19713

NOT_YET_RECRUITING

Local Institution - 0304, Newark

20014

NOT_YET_RECRUITING

Local Institution - 0139, Donostia / San Sebastian

20141

NOT_YET_RECRUITING

Local Institution - 0052, Milan

21079

NOT_YET_RECRUITING

Local Institution - 0272, Dijon

22010

NOT_YET_RECRUITING

Local Institution - 0264, Tijuana

22601

NOT_YET_RECRUITING

Local Institution - 0302, Winchester

23114

NOT_YET_RECRUITING

Local Institution - 0277, Midlothian

23538

NOT_YET_RECRUITING

Local Institution - 0255, Lübeck

24014

NOT_YET_RECRUITING

Local Institution - 0301, Roanoke

27710

NOT_YET_RECRUITING

Local Institution - 0276, Durham

28007

NOT_YET_RECRUITING

Local Institution - 0107, Madrid

28009

NOT_YET_RECRUITING

Local Institution - 0104, Madrid

28041

NOT_YET_RECRUITING

Local Institution - 0108, Madrid

28100

NOT_YET_RECRUITING

Local Institution - 0061, Novara

29010

NOT_YET_RECRUITING

Local Institution - 0101, Málaga

29607

NOT_YET_RECRUITING

Local Institution - 0281, Greenville

30322

NOT_YET_RECRUITING

Local Institution - 0294, Atlanta

30342

NOT_YET_RECRUITING

Local Institution - 0357, Atlanta

30625

NOT_YET_RECRUITING

Local Institution - 0257, Hanover

31059

NOT_YET_RECRUITING

Local Institution - 0098, Toulouse

31207

NOT_YET_RECRUITING

Local Institution - 0174, Chihuahua City

33028

NOT_YET_RECRUITING

Local Institution - 0296, Pembroke Pines

33076

NOT_YET_RECRUITING

Local Institution - 0089, Bordeaux

33081

NOT_YET_RECRUITING

Local Institution - 0057, Aviano

33136

NOT_YET_RECRUITING

Local Institution - 0282, Miami

34295

NOT_YET_RECRUITING

Local Institution - 0364, Istanbul

34298

NOT_YET_RECRUITING

Local Institution - 0095, Montpellier

34722

NOT_YET_RECRUITING

Local Institution - 0363, Istanbul

35042

NOT_YET_RECRUITING

Local Institution - 0099, Rennes

35128

NOT_YET_RECRUITING

Local Institution - 0056, Padua

38100

NOT_YET_RECRUITING

Local Institution - 0048, Hadera

40138

NOT_YET_RECRUITING

Local Institution - 0049, Bologna

40235

NOT_YET_RECRUITING

Local Institution - 0293, Düsseldorf

41009

NOT_YET_RECRUITING

Local Institution - 0103, Seville

41404

NOT_YET_RECRUITING

Local Institution - 0069, Daegu

44680

NOT_YET_RECRUITING

Local Institution - 0178, Guadalajara

44805

NOT_YET_RECRUITING

Local Institution - 0092, Saint-Herblain

45136

NOT_YET_RECRUITING

Local Institution - 0263, Essen

46010

NOT_YET_RECRUITING

Local Institution - 0210, Valencia

48202

NOT_YET_RECRUITING

Local Institution - 0359, Detroit

50021

WITHDRAWN

Local Institution - 0195, Medellín

51726

WITHDRAWN

Local Institution - 0091, Reims

53111

NOT_YET_RECRUITING

Local Institution - 0259, Bonn

55404

NOT_YET_RECRUITING

Local Institution - 0313, Minneapolis

56025

NOT_YET_RECRUITING

Local Institution - 0053, Pontedera

59000

NOT_YET_RECRUITING

Local Institution - 0094, Lille

59100

NOT_YET_RECRUITING

Local Institution - 0055, Prato

60590

NOT_YET_RECRUITING

Local Institution - 0306, Frankfurt am Main

60612

WITHDRAWN

Local Institution - 0278, Chicago

60637

NOT_YET_RECRUITING

Local Institution - 0280, Chicago

62269

WITHDRAWN

Local Institution - 0324, O'Fallon

62526

RECRUITING

Decatur Memorial Hospital, Decatur

63011

NOT_YET_RECRUITING

Local Institution - 0096, Clermont-Ferrand

63225

NOT_YET_RECRUITING

Local Institution - 0333, Langen

64111

NOT_YET_RECRUITING

Local Institution - 0284, Kansas City

64320

NOT_YET_RECRUITING

Local Institution - 0175, Monterrey

64460

NOT_YET_RECRUITING

Local Institution - 0176, Monterrey

WITHDRAWN

Local Institution - 0355, Monterrey

68020

NOT_YET_RECRUITING

Local Institution - 0173, Oaxaca City

69008

NOT_YET_RECRUITING

Local Institution - 0090, Lyon

70433

NOT_YET_RECRUITING

Local Institution - 0286, Covington

71913

NOT_YET_RECRUITING

Local Institution - 0303, Hot Springs

73730

NOT_YET_RECRUITING

Local Institution - 0320, Esslingen am Neckar

75248

WITHDRAWN

Local Institution - 0088, Paris

75702

NOT_YET_RECRUITING

Local Institution - 0305, Tyler

78705

NOT_YET_RECRUITING

Local Institution - 0315, Austin

79606

NOT_YET_RECRUITING

Local Institution - 0368, Abilene

80045

NOT_YET_RECRUITING

Local Institution - 0289, Aurora

80131

NOT_YET_RECRUITING

Local Institution - 0051, Napoli

NOT_YET_RECRUITING

Local Institution - 0058, Napoli

80220

NOT_YET_RECRUITING

Local Institution - 0367, Denver

80637

NOT_YET_RECRUITING

Local Institution - 0271, München

81001

WITHDRAWN

Local Institution - 0182, Puerto Colombia

86156

NOT_YET_RECRUITING

Local Institution - 0256, Augsburg

89081

NOT_YET_RECRUITING

Local Institution - 0291, Ulm

90033

NOT_YET_RECRUITING

Local Institution - 0290, Los Angeles

90067

RECRUITING

Valkyrie Clinical Trials, Los Angeles

90703

RECRUITING

Helios Clinical Research, Cerritos

WITHDRAWN

Local Institution - 0307, Cerritos

WITHDRAWN

Local Institution - 0308, Cerritos

WITHDRAWN

Local Institution - 0309, Cerritos

90805

WITHDRAWN

Local Institution - 0311, Long Beach

92510

NOT_YET_RECRUITING

Local Institution - 0318, Abu Dhabi

92663

NOT_YET_RECRUITING

Local Institution - 0353, Newport Beach

94305

NOT_YET_RECRUITING

Local Institution - 0358, Stanford

94800

NOT_YET_RECRUITING

Local Institution - 0097, Villejuif

97000

NOT_YET_RECRUITING

Local Institution - 0179, Mérida

97401

NOT_YET_RECRUITING

Local Institution - 0316, Eugene

100337

NOT_YET_RECRUITING

Local Institution - 0084, Ploieşti

110017

NOT_YET_RECRUITING

Local Institution - 0352, New Delhi

110029

NOT_YET_RECRUITING

Local Institution - 0266, New Delhi

110085

NOT_YET_RECRUITING

Local Institution - 0206, New Delhi

111151

NOT_YET_RECRUITING

Local Institution - 0327, Bogota

200746

NOT_YET_RECRUITING

Local Institution - 0078, Craiova

221005

NOT_YET_RECRUITING

Local Institution - 0133, Varanasi

230002

NOT_YET_RECRUITING

Local Institution - 0181, Montería

300239

NOT_YET_RECRUITING

Local Institution - 0085, Timișoara

307160

NOT_YET_RECRUITING

Local Institution - 0211, Dumbrăviţa

400012

NOT_YET_RECRUITING

Local Institution - 0131, Mumbai

400015

NOT_YET_RECRUITING

Local Institution - 0077, Cluj-Napoca

407280

NOT_YET_RECRUITING

Local Institution - 0079, Florești

420020

NOT_YET_RECRUITING

Local Institution - 0212, Bistriţa

440001

NOT_YET_RECRUITING

Local Institution - 0134, Nagpur

500082

NOT_YET_RECRUITING

Local Institution - 0130, Hyderabad

600035

NOT_YET_RECRUITING

Local Institution - 0125, Chennai

700106

NOT_YET_RECRUITING

Local Institution - 0081, Iași

700483

NOT_YET_RECRUITING

Local Institution - 0080, Iași

760032

NOT_YET_RECRUITING

Local Institution - 0183, Santiago de Cali

2418515

NOT_YET_RECRUITING

Local Institution - 0237, Yokohama

2520598

NOT_YET_RECRUITING

Local Institution - 0016, Viña del Mar

3109601

NOT_YET_RECRUITING

Local Institution - 0123, Haifa

4941492

NOT_YET_RECRUITING

Local Institution - 0186, Petah Tikva

5265601

NOT_YET_RECRUITING

Local Institution - 0044, Ramat Gan

7308518

NOT_YET_RECRUITING

Local Institution - 0243, Hiroshima

7500921

NOT_YET_RECRUITING

Local Institution - 0138, Santiago

7650568

NOT_YET_RECRUITING

Local Institution - 0021, Santiago

8330032

NOT_YET_RECRUITING

Local Institution - 0017, Santiago

8420383

NOT_YET_RECRUITING

Local Institution - 0018, Santiago

9112001

NOT_YET_RECRUITING

Local Institution - 0047, Jerusalem

9208530

NOT_YET_RECRUITING

Local Institution - 0232, Kanazawa

14784400

NOT_YET_RECRUITING

Local Institution - 0148, Barretos

29055450

NOT_YET_RECRUITING

Local Institution - 0157, Vitória

02114

NOT_YET_RECRUITING

Local Institution - 0288, Boston

02215

NOT_YET_RECRUITING

Local Institution - 0287, Boston

19104-5127

NOT_YET_RECRUITING

Local Institution - 0310, Philadelphia

15213-3403

NOT_YET_RECRUITING

Local Institution - 0360, Pittsburgh

77024-2843

NOT_YET_RECRUITING

Local Institution - 0314, Houston

X5004BAL

NOT_YET_RECRUITING

Local Institution - 0143, Córdoba

X5800ALB

RECRUITING

Centro Privado de RMI Río Cuarto S.A. II, Río Cuarto

69020-030

NOT_YET_RECRUITING

Local Institution - 0187, Manaus

60135-237

NOT_YET_RECRUITING

Local Institution - 0147, Fortaleza

81480-580

NOT_YET_RECRUITING

Local Institution - 0159, Curitiba

90470-340

NOT_YET_RECRUITING

Local Institution - 0199, Porto Alegre

15090-000

NOT_YET_RECRUITING

Local Institution - 0164, São José do Rio Preto

20230-130

NOT_YET_RECRUITING

Local Institution - 0153, Rio de Janeiro

01317-000

NOT_YET_RECRUITING

Local Institution - 0144, São Paulo

01401-002

NOT_YET_RECRUITING

Local Institution - 0149, São Paulo

V1Y 5L3

NOT_YET_RECRUITING

Local Institution - 0218, Kelowna

V8R 6V5

NOT_YET_RECRUITING

Local Institution - 0217, Victoria

K1H 8L6

NOT_YET_RECRUITING

Local Institution - 0265, Ottawa

H2X 3E4

NOT_YET_RECRUITING

Local Institution - 0215, Montreal

H4A 3J1

RECRUITING

McGill University Health Centre, Montreal

J6E 6J2

NOT_YET_RECRUITING

Local Institution - 0350, Saint-Charles-Borromée

J1H 5N4

NOT_YET_RECRUITING

Local Institution - 0216, Sherbrooke

054047

NOT_YET_RECRUITING

Local Institution - 0201, Rionegro

080020

NOT_YET_RECRUITING

Local Institution - 0194, Barranquilla

050030

NOT_YET_RECRUITING

Local Institution - 0349, Medellín

04103

NOT_YET_RECRUITING

Local Institution - 0254, Leipzig

01307

NOT_YET_RECRUITING

Local Institution - 0258, Dresden

D-69120

NOT_YET_RECRUITING

Local Institution - 0262, Heidelberg

115 28

NOT_YET_RECRUITING

Local Institution - 0043, Athens

115 22

NOT_YET_RECRUITING

Local Institution - 0042, Athens

185 47

NOT_YET_RECRUITING

Local Institution - 0038, Athens

715 00

NOT_YET_RECRUITING

Local Institution - 0086, Heraklion

400 057

WITHDRAWN

Local Institution - 0337, Mumbai

00168

NOT_YET_RECRUITING

Local Institution - 0062, Roma

464-8681

NOT_YET_RECRUITING

Local Institution - 0236, Nagoya

260-8717

NOT_YET_RECRUITING

Local Institution - 0230, Chiba

791-0280

NOT_YET_RECRUITING

Local Institution - 0240, Matsuyama

373-8550

NOT_YET_RECRUITING

Local Institution - 0226, Otashi

003-0804

NOT_YET_RECRUITING

Local Institution - 0222, Sapporo

259-1193

NOT_YET_RECRUITING

Local Institution - 0234, Isehara

514-8507

NOT_YET_RECRUITING

Local Institution - 0246, Tsu

980-8574

NOT_YET_RECRUITING

Local Institution - 0223, Sendai

565-0871

NOT_YET_RECRUITING

Local Institution - 0238, Suita

350-1298

NOT_YET_RECRUITING

Local Institution - 0227, Hidaka

362-0806

NOT_YET_RECRUITING

Local Institution - 0224, Ina-machi

113-8431

NOT_YET_RECRUITING

Local Institution - 0231, Bunkyo-ku

104-0045

NOT_YET_RECRUITING

Local Institution - 0229, Chuo-ku

135-8550

NOT_YET_RECRUITING

Local Institution - 0228, Koto

142-8666

NOT_YET_RECRUITING

Local Institution - 0245, Shinagawa

160-0023

NOT_YET_RECRUITING

Local Institution - 0233, Shinjuku-ku

811-1395

NOT_YET_RECRUITING

Local Institution - 0242, Fukuoka

960-1295

NOT_YET_RECRUITING

Local Institution - 0225, Fukushima

892-0833

NOT_YET_RECRUITING

Local Institution - 0244, Kagoshima

606-8507

NOT_YET_RECRUITING

Local Institution - 0235, Kyoto

700-8558

NOT_YET_RECRUITING

Local Institution - 0241, Okayama

541-8567

NOT_YET_RECRUITING

Local Institution - 0239, Osaka

03100

NOT_YET_RECRUITING

Local Institution - 0177, Mexico City

60-185

NOT_YET_RECRUITING

Local Institution - 0189, Skórzewo

21-500

NOT_YET_RECRUITING

Local Institution - 0074, Biała Podlaska

02-781

NOT_YET_RECRUITING

Local Institution - 0072, Warsaw

03-411

NOT_YET_RECRUITING

Local Institution - 0220, Warsaw

45-061

NOT_YET_RECRUITING

Local Institution - 0076, Opole

93-338

NOT_YET_RECRUITING

Local Institution - 0221, Lodz

1099-023

NOT_YET_RECRUITING

Local Institution - 0198, Lisbon

1400-038

NOT_YET_RECRUITING

Local Institution - 0106, Lisbon

1649-035

NOT_YET_RECRUITING

Local Institution - 0109, Lisbon

3000-075

NOT_YET_RECRUITING

Local Institution - 0124, Coimbra

1500-650

NOT_YET_RECRUITING

Local Institution - 0141, Lisbon

4200-072

NOT_YET_RECRUITING

Local Institution - 0111, Porto

4200-319

NOT_YET_RECRUITING

Local Institution - 0253, Porto

012292

NOT_YET_RECRUITING

Local Institution - 0213, Bucharest

011171

NOT_YET_RECRUITING

Local Institution - 0083, Bucharest

0083

NOT_YET_RECRUITING

Local Institution - 0336, Pretoria

0084

NOT_YET_RECRUITING

Local Institution - 0341, Pretoria

02841

NOT_YET_RECRUITING

Local Institution - 0068, Seoul

03080

NOT_YET_RECRUITING

Local Institution - 0063, Seoul

03722

NOT_YET_RECRUITING

Local Institution - 0071, Seoul

05505

NOT_YET_RECRUITING

Local Institution - 0064, Seoul

06351

NOT_YET_RECRUITING

Local Institution - 0065, Seoul

03203

NOT_YET_RECRUITING

Local Institution - 0100, Elche

08035

NOT_YET_RECRUITING

Local Institution - 0102, Barcelona

08907

NOT_YET_RECRUITING

Local Institution - 0172, Hospitalet

08036

NOT_YET_RECRUITING

Local Institution - 0140, Barcelona

205 02

NOT_YET_RECRUITING

Local Institution - 0252, Malmo

112 19

NOT_YET_RECRUITING

Local Institution - 0026, Stockholm

751 85

NOT_YET_RECRUITING

Local Institution - 0025, Uppsala

701 85

NOT_YET_RECRUITING

Local Institution - 0024, Örebro

581 85

NOT_YET_RECRUITING

Local Institution - 0247, Linköping

01123

NOT_YET_RECRUITING

Local Institution - 0361, Adana

06800

NOT_YET_RECRUITING

Local Institution - 0362, Ankara

TR1 3LJ

RECRUITING

The Royal Cornwall Hospital, Truro

EC1A 7BE

RECRUITING

St Bartholomew's Hospital, London

SE1 9RT

WITHDRAWN

Local Institution - 0204, London

NOT_YET_RECRUITING

Local Institution - 0209, London

BT9 7AB

NOT_YET_RECRUITING

Local Institution - 0171, Belfast

M20 4BX

RECRUITING

The Christie NHS Foundation Trust, Manchester

NG5 1PB

NOT_YET_RECRUITING

Local Institution - 0006, Nottingham

Sponsors
All Listed Sponsors
collaborator

SystImmune Inc.

INDUSTRY

lead

Bristol-Myers Squibb

INDUSTRY

NCT06926868 - 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) | Biotech Hunter | Biotech Hunter