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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Incidence and severity of dose-limiting toxicities (DLTs) — 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.
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) — 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.
Frequency of dose interruptions, reductions and discontinuations — Up to approximately 2 years Number of participants with dose adjustments (interruptions, reductions, or permanent discontinuation) as a measure of tolerability.
Dose intensity — Up to approximately 2 years Dose intensity defined as the ratio of actual cumulative dose received and actual duration of exposure.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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