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RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: Novartis Pharmaceuticals • ClinicalTrials.gov ID: NCT07604571

Registry updated: 2026-10-20
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Description

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.

Interventions

  • IEV407 (Drug)
    Oral administration
  • Fulvestrant (Drug)
    Intramuscular injection. Approved medication.
  • Letrozole (Drug)
    Oral administration. Approved medication.

Eligibility criteria

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.

Conditions

Advanced HR+/HER2- Breast Cancer

Locations

  • Yale New Haven Hospital — New Haven, Connecticut, United States
  • Univ of Kansas Hosp and Med Ctr — Kansas City, Kansas, United States
  • Mary Crowley Cancer Research — Dallas, Texas, United States
  • Novartis Investigative Site — Toronto, Ontario, Canada
  • Novartis Investigative Site — Marseille, France
  • Novartis Investigative Site — Toulouse, France
  • Novartis Investigative Site — Ancona, AN, Italy
  • Novartis Investigative Site — Hirakata, Osaka, Japan
  • Novartis Investigative Site — Singapore, Singapore
  • Novartis Investigative Site — Seoul, Seoul, South Korea
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record