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

1. juni 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

194

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: Novartis Pharmaceuticals
  • Telefonnummer: +41613241111

Studiesteder

  • Singapore
      • Singapore, Singapore, 119074
        • Rekruttering
        • Novartis Investigative Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Dose escalation: IEV407 single agent
IEV407 single agent
Medicin: IEV407
Oral administration
Eksperimentel: Dose escalation: IEV407 + fulvestrant
IEV407 in combination with fulvestrant
Medicin: Fulvestrant
Intramuscular injection. Approved medication.
Andre navne:
  • Faslodex
Medicin: IEV407
Oral administration
Eksperimentel: Dose escalation: IEV407 + letrozole
IEV407 in combination with letrozole
Medicin: Letrozole
Oral administration. Approved medication.
Andre navne:
  • Femara
Medicin: IEV407
Oral administration
Eksperimentel: Dose expansion, recommended dose (RD)-1: IEV407 + fulvestrant
IEV407 in combination with fulvestrant
Medicin: Fulvestrant
Intramuscular injection. Approved medication.
Andre navne:
  • Faslodex
Medicin: IEV407
Oral administration
Eksperimentel: Dose expansion, RD-2 (optional dose optimization): IEV407 + fulvestrant
IEV407 in combination with fulvestrant
Medicin: Fulvestrant
Intramuscular injection. Approved medication.
Andre navne:
  • Faslodex
Medicin: IEV407
Oral administration

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence and severity of dose-limiting toxicities (DLTs)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Best Overall Response (BOR)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Novartis Pharmaceuticals

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

28. maj 2026

Primær færdiggørelse (Anslået)

8. juni 2032

Studieafslutning (Anslået)

8. juni 2032

Datoer for studieregistrering

Først indsendt

18. maj 2026

Først indsendt, der opfyldte QC-kriterier

18. maj 2026

Først opslået (Faktiske)

22. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CIEV407A12101
  • 2025-522707-26 (Registry Identifier: EU CTIS)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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/.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Avanceret HR+/HER2- Brystkræft

Kliniske forsøg med Fulvestrant

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