NCT06926868Recrutement en cours
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)
Résumé
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.
Critères d'inclusion
• Histologically or cytologically confirmed and documented locally-advanced, recurrent inoperable, or metastatic triple-negative breast cancer (TNBC) (ER \< 1%, PgR \< 1%, HER2 IHC 0, 1+, or 2+ with ISH negative for HER2 gene amplification) or ER-low, HER2-negative BC (ER and / or PgR 1% to 10%, HER2 IHC 0, 1+, or 2+ with ISH negative for HER2 gene amplification) per American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) criteria, based on the most recently analyzed biopsy or other pathology specimen. • Patients with recurrent disease must have experienced disease relapse at least 6 months after finishing their last therapy with curative intent. • Participants with TNBC must be considered ineligible for 1L chemotherapy combination treatment with an anti-PD-1 (eg, pembrolizumab) or an anti-PD-L1 (eg, atezolizumab) due to any one of the following criteria: i) Investigator-determined ineligibility based on PD-L1 negative disease determined and documented prior to trial screening as part of standard of care (SoC); ii) Has experienced disease relapse between 6 to 12 months after the completion of (neo)adjuvant therapy with an anti-PD(L)1; iii) Has a severe auto-immune disease or other contraindication, in the opinion of the investigator, for the use of an anti-PD(L)1 drug: iv) Any auto-immune disease that requires current immunosuppression (eg, methotrexate, cyclophosphamide, prednisone \> 10 mg/day). v) Prior auto-immune AE to peri-adjuvant ICI that required immunosuppression. vi) Current Graves' disease with ophthalmopathy or in need of radioiodine or in use of antithyroid medication. vii) Current or prior auto-immune diseases per below: A. Moderate to severe rheumatoid arthritis. B. Auto-immune hepatitis or cholangitis. C. Myasthenia gravis. D. Moderate-to-severe or poorly controlled inflammatory bowel disease. E. Multiple sclerosis. F. Lupus with kidney involvement or moderate to severe lupus. G. Auto-immune myocarditis. Note: if participant meets Inclusion Criteria 5b or 5c, unknown PDL1 results per local SOC are acceptable in these specific cases. • Patients with ER-low, HER2-negative BC must be ineligible, in the opinion of the Investigator, for endocrine therapy-based treatments. • No previous systemic therapy in the locally advanced, recurrent inoperable or metastatic setting (ie incurable setting). • Measurable disease by CT or MRI as per RECIST v1.1.
Critères d'exclusion
• Participants with a known germline breast cancer gene (BRCA) 1 or 2 mutation whose best 1L treatment option, in the opinion of the investigator, is a poli-ADP-ribose-polymerase inhibitors (PARPi). • Untreated symptomatic central nervous system (CNS) metastases. Participants are eligible if CNS metastases have been treated, and participants' neurological signs and symptoms have returned to baseline. In addition, participants must have been either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent) for at least 2 weeks prior to randomization. Imaging performed within 28 days of randomization must document radiographic stability of CNS lesions and be performed after completion of any CNS directed therapy. • Leptomeningeal metastases. • Participants with history of severe heart disease including, but not limited to, any of the following: i) History of clinically significant heart disease (eg, cardiomyopathy, congestive heart failure with New York Heart Association functional classification II to IV, pericarditis, or significant pericardial effusion). ii) Myocardial infarction, uncontrolled angina, or stroke/transient ischemic attack within the past 6 months. iii) QTc (by Fridericia's formula) prolongation ≥ 450 msec for males and ≥ 470 msec for females, except for right bundle branch block. iv) Known LVEF \< 50%. • Prior therapy with iza-bren or any other ADC targeting EGFR and/or HER3 or containing a topoisomerase 1 inhibitor payload. • Other protocol-defined Inclusion/Exclusion criteria apply.
Contacts
Les coordonnées de l'équipe de l'essai s'affichent sur demande.
Voir la fiche officielle de l'essai- Statut
- Recrutement en cours
- Phase
- Phase 2 · Phase 3
- Type d'étude
- Interventionnelle
- Pays
- Suisse, France, Allemagne, Italie, Autriche, États-Unis, Argentine, Australie, Brésil, Canada, Chili, Chine, Colombie, Grèce, Inde, Israël, Japon, Mexique, Pologne, Portugal, Roumanie, Afrique du Sud, Corée du Sud, Espagne, Suède, Turquie, Émirats arabes unis, Royaume-Uni
- Promoteur
- Bristol-Myers Squibb(Industrie)
- N° de protocole
- CA244-0008
- Pathologies
- Breast Neoplasms
- Interventions
- Médicament
Traitements évalués
- Iza-bren
- Nab-paclitaxel
- Paclitaxel
- Capecitabine
- Carboplatin
- Gemcitabine
Collaborateurs
SystImmune Inc.
Lieux · 168
- Sankt Gallen, SuisseCantonal Hospital St.GallenRecrute dans ce centre
- Lausanne, SuisseCHUV (centre hospitalier universitaire vaudois)Recrute dans ce centre
- Zurich, SuisseBrust-ZentrumRecrute dans ce centre
- Bordeaux, FranceInstitut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud OuestRecrute dans ce centre
- Dijon, FranceCentre Georges François LeclercRecrute dans ce centre
- Montpellier, FranceInstitut Régional du Cancer MontpellierRecrute dans ce centre
- Rennes, FranceCentre Eugène Marquis Rennes - Centre de Lutte Contre le CancerRecrute dans ce centre
- Saint-Herblain, FranceInstitut de Cancérologie de l'OuestRecrute dans ce centre
- Villejuif, FranceGustave RoussyRecrute dans ce centre
- Marseille, FranceInstitut Paoli-CalmettesRecrute dans ce centre
- Clermont-Ferrand, FranceCentre Jean Perrin - Centre Régional de Lutte contre le Cancer d'AuvergneRecrute dans ce centre
- Lille, FranceCentre Oscar LambretRecrute dans ce centre
- Esslingen am Neckar, AllemagneKlinikum EsslingenRecrute dans ce centre
- Augsburg, AllemagneKlinikum AugsburgRecrute dans ce centre
- München, AllemagneRotkreuzklinikum München gemeinnützige GmbHRecrute dans ce centre
- Frankfurt am Main, AllemagneUniversitätsklinikum Frankfurt Goethe-UniversitätRecrute dans ce centre
- Langen, AllemagneGemeinschaftspraxis für Hämatologie und OnkologieRecrute dans ce centre
- Hanover, AllemagneMedizinische Hochschule HannoverRecrute dans ce centre
- Essen, AllemagneKliniken Essen-Mitte, Evangelische Huyssens-StiftungRecrute dans ce centre
- Lübeck, AllemagneUniversitätsklinikum Schleswig-HolsteinRecrute dans ce centre
- Berlin, AllemagneCharité - Universitaetsmedizin Berlin - Campus Bejnamin FranklinRecrute dans ce centre
- Berlin, AllemagneVivantes Klinikum Am UrbanRecrute dans ce centre
- Bonn, AllemagneGynaekologisches Zentrum BonnRecrute dans ce centre
- Dresden, AllemagneUniversitaetsklinikum Carl Gustav Carus DresdenRecrute dans ce centre
- Heidelberg, AllemagneUniversitaetsklinikum HeidelbergRecrute dans ce centre
- Ulm, AllemagneUniversitaetsklinikum UlmRecrute dans ce centre
- Naples, ItalieIstituto Nazionale Tumori IRCCS Fondazione PascaleRecrute dans ce centre
- Bologna, ItalieIRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'OrsolaRecrute dans ce centre
- Aviano, ItalieCro-IrccsRecrute dans ce centre
- Genoa, ItalieOspedale San MartinoRecrute dans ce centre
Au total, dans le monde, 168 des 295 centres listés au registre recrutent ; les 127 autres ne recrutent pas actuellement.
Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 10 août 2026).
Ce statut peut avoir changé et ne dit rien de votre éligibilité : avant toute démarche, vérifiez avec votre oncologue ou le centre.
+ 138 autres lieux
Autres identifiants
- 2024-519871-24 · autre identifiant
- U1111-1316-1533 · autre identifiant
Voir aussi
Autres versions
Ces résultats sont indicatifs et ne remplacent pas un avis médical — à discuter avec votre médecin.