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NCT Number: NCT07604571

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

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Key information

Conditions

Advanced HR+/HER2- Breast Cancer

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Hirakata, Osaka, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IEV407

Drug

Oral administration

Fulvestrant

Drug

Intramuscular injection. Approved medication.

Other names: Faslodex

letrozole

Drug

Oral administration. Approved medication.

Other names: Femara

Primary outcomes

  1. Incidence and severity of dose-limiting toxicities (DLTs)

    Time frame: 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.

  2. Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: 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.

  3. Frequency of dose interruptions, reductions and discontinuations

    Time frame: Up to approximately 2 years

    Number of participants with dose adjustments (interruptions, reductions, or permanent discontinuation) as a measure of tolerability.

  4. Dose intensity

    Time frame: Up to approximately 2 years

    Dose intensity defined as the ratio of actual cumulative dose received and actual duration of exposure.

Secondary outcomes

  1. Best Overall Response (BOR)

    Time frame: 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.

  2. Overall Response Rate (ORR)

    Time frame: 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.

  3. Disease Control Rate (DCR)

    Time frame: 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.

  4. Clinical Benefit Rate (CBR)

    Time frame: 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.

  5. Duration of Response (DOR)

    Time frame: 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.

  6. Progression Free Survival (PFS)

    Time frame: 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.

  7. Maximum plasma concentration (Cmax) of IEV407

    Time frame: 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.

  8. Area under the plasma concentration-time curve (AUC) of IEV407

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Novartis Pharmaceuticals

CONTACT

[email protected]

1-888-669-6682

Novartis Pharmaceuticals

CONTACT

+41613241111

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2032
Study completion
2032
First posted
May 22, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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