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Study of IEV407 as Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer

3 septembre 2026 mis à jour par: Novartis Pharmaceuticals

An Open-label, Multi-center, Phase I/Ib Study of IEV407 as a Single Agent and in Combination With Endocrine Therapy in Patients With Advanced Hormone Receptor Positive, HER2- Negative Breast Cancer

The purpose of this study is to evaluate the safety, tolerability and preliminary activity of IEV407 as a single agent and in combination with endocrine therapy (fulvestrant or letrozole) in patients with advanced hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-negative) breast cancer.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

This is a first-in-human, open-label, phase I/Ib, multi-center study consisting of a dose escalation part of IEV407 as a single agent (SA) and in combination with endocrine therapy (fulvestrant or letrozole) followed by a dose expansion part in patients with advanced breast cancer (aBC). The study will start with the evaluation of IEV407 as a SA.

Following evaluation of IEV407 in combination with fulvestrant through dose escalation and establishment of a recommended dose and/or dose ranges for optimization (RD/DRO), the study may proceed to the Phase Ib expansion part to evaluate the combination treatment of IEV407 with fulvestrant. If more than one treatment arm is open concurrently in the dose expansion part, a randomization schedule will be employed for patient allocation.

Type d'étude

Interventionnel

Inscription (Estimé)

194

Phase

  • La phase 1

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

  • Nom: Novartis Pharmaceuticals
  • Numéro de téléphone: +41613241111

Lieux d'étude

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recrutement
        • Novartis Investigative Site
  • Corée du Sud
    • Seoul
      • Seoul, Seoul, Corée du Sud, 06351
        • Recrutement
        • Novartis Investigative Site
  • Japon
    • Osaka
      • Hirakata, Osaka, Japon, 5731191
        • Recrutement
        • Novartis Investigative Site
  • Singapour
      • Singapore, Singapour, 119074
        • Recrutement
        • Novartis Investigative Site
  • États-Unis
    • Connecticut
      • New Haven, Connecticut, États-Unis, 06520
        • Recrutement
        • Yale New Haven Hospital
        • Contact:
        • Chercheur principal:
          • Jing Du
    • Texas
      • Dallas, Texas, États-Unis, 75251
        • Recrutement
        • Mary Crowley Cancer Research
        • Chercheur principal:
          • Reva Schneider
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • Age ≥ 18 years old

  • Patients with one of the following indications:

    • Dose escalation (IEV407 single agent and in combination with fulvestrant or letrozole):

HR+/HER2- aBC with disease progression on or following, or have been intolerant to, at least one line of endocrine-based therapy in combination with a CDK4/6 inhibitor and at least one additional line of systemic therapy in the unresectable/metastatic setting and not be a candidate for any available standard therapy, in the investigator's judgement.

- Dose expansion of IEV407 in combination with fulvestrant: HR+/HER2- aBC with disease progression on or following, or have been intolerant to, endocrine-based therapy in combination with a CDK4/6 inhibitor. They must not have received more than two prior lines of endocrine-based therapy in the unresectable/metastatic setting. Prior cytotoxic chemotherapy and/or antibody-drug conjugate therapies in the unresectable/metastatic setting are not allowed.

Exclusion Criteria:

  • Patients with inadequate bone marrow and/or organ functions with out-of-range laboratory values.
  • Impaired cardiac function or clinically significant cardiac disease.
  • Concurrent use of hormone replacement therapy.
  • Women of childbearing potential who are unwilling to use highly effective contraception methods, pregnant or nursing women.
  • For the combination treatment of IEV407 with fulvestrant or letrozole: Patients with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine-based therapy.

Other protocol-defined inclusion/exclusion criteria may apply.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation séquentielle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Dose escalation: IEV407 single agent
IEV407 single agent
Médicament: IEV407
Oral administration
Expérimental: Dose escalation: IEV407 + fulvestrant
IEV407 in combination with fulvestrant
Médicament: Fulvestrant
Intramuscular injection. Approved medication.
Autres noms:
  • Faslodex
Médicament: IEV407
Oral administration
Expérimental: Dose escalation: IEV407 + letrozole
IEV407 in combination with letrozole
Médicament: Letrozole
Oral administration. Approved medication.
Autres noms:
  • Fémara
Médicament: IEV407
Oral administration
Expérimental: Dose expansion, recommended dose (RD)-1: IEV407 + fulvestrant
IEV407 in combination with fulvestrant
Médicament: Fulvestrant
Intramuscular injection. Approved medication.
Autres noms:
  • Faslodex
Médicament: IEV407
Oral administration
Expérimental: Dose expansion, RD-2 (optional dose optimization): IEV407 + fulvestrant
IEV407 in combination with fulvestrant
Médicament: Fulvestrant
Intramuscular injection. Approved medication.
Autres noms:
  • Faslodex
Médicament: IEV407
Oral administration

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Incidence and severity of dose-limiting toxicities (DLTs)
Délai: 28 days
Number of participants with DLTs. A DLT is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher, including death, unless clearly and incontrovertibly assessed as due to disease, disease progression, inter-current illness/injury, concomitant medications, or extraneous causes, that occurs within the first 28 days of treatment with IEV407 in the dose escalation parts or in the expansion part of IEV407 in combination with fulvestrant with the exceptions described in the study protocol.
28 days
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Délai: Up to approximately 2 years
Number of participants with AEs and SAEs, including changes in laboratory values, vital signs and echocardiograms (ECGs) qualifying and reported as AEs.
Up to approximately 2 years
Frequency of dose interruptions, reductions and discontinuations
Délai: Up to approximately 2 years
Number of participants with dose adjustments (interruptions, reductions, or permanent discontinuation) as a measure of tolerability.
Up to approximately 2 years
Dose intensity
Délai: Up to approximately 2 years
Dose intensity defined as the ratio of actual cumulative dose received and actual duration of exposure.
Up to approximately 2 years

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Best Overall Response (BOR)
Délai: Up to approximately 2 years
BOR per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) is defined as the best overall confirmed response recorded from the start of the treatment until progressive disease (PD), death, start of new therapy, withdrawal of consent or end of study, whatever comes first. Efficacy will be based on the investigator assessment.
Up to approximately 2 years
Overall Response Rate (ORR)
Délai: Up to approximately 2 years

ORR per RECIST v1.1 is defined as the proportion of patients with a BOR of Complete response (CR) or Partial response (PR).

Efficacy will be based on the investigator assessment.
Up to approximately 2 years
Disease Control Rate (DCR)
Délai: Up to approximately 2 years

DCR per RECIST v1.1 is defined as the proportion of patients with a BOR of CR, PR, or Stable Disease (SD).

Efficacy will be based on the investigator assessment.
Up to approximately 2 years
Clinical Benefit Rate (CBR)
Délai: Up to approximately 2 years

CBR per RECIST v1.1 is defined as the proportion of patients with a BOR of CR, PR, or an overall lesion response of SD or Non-CR/Non-PD which lasts for at least 24 weeks.

Efficacy will be based on the investigator assessment.
Up to approximately 2 years
Duration of Response (DOR)
Délai: Up to approximately 2 years

DOR per RECIST v1.1 is the time between the first documented response (CR or PR) and the date of progression by local review as applicable or death due to any cause.

Efficacy will be based on the investigator assessment.
Up to approximately 2 years
Progression Free Survival (PFS)
Délai: Up to approximately 2 years

PFS per RECIST 1.1 is defined as the time from the date of start of study treatment (Phase I) or the date of randomization (Phase II) to the date of the first documented progression or death due to any cause.

Efficacy will be based on the investigator assessment.
Up to approximately 2 years
Maximum plasma concentration (Cmax) of IEV407
Délai: From pre-dose up to 24 hours after dosing on Cycle 1 Day 1 and Day 15. 1 cycle = 28 days
Pharmacokinetic (PK) parameters based on plasma concentrations of IEV407.
From pre-dose up to 24 hours after dosing on Cycle 1 Day 1 and Day 15. 1 cycle = 28 days
Area under the plasma concentration-time curve (AUC) of IEV407
Délai: From pre-dose up to 24 hours after dosing on Cycle 1 Day 1 and Day 15. 1 cycle = 28 days
PK parameters based on plasma concentrations of IEV407.
From pre-dose up to 24 hours after dosing on Cycle 1 Day 1 and Day 15. 1 cycle = 28 days

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Novartis Pharmaceuticals

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

28 mai 2026

Achèvement primaire (Estimé)

8 juin 2032

Achèvement de l'étude (Estimé)

8 juin 2032

Dates d'inscription aux études

Première soumission

18 mai 2026

Première soumission répondant aux critères de contrôle qualité

18 mai 2026

Première publication (Réel)

22 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

4 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CIEV407A12101
  • 2025 (Subvention/contrat des NIH des États-Unis: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-522707-26 (Identificateur de registre: EU CTIS)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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