NIPH Clinical Trials Search

Study of IEV407 as single agent or in combination in patients with advanced HR+/HER2- breast cancer

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Advanced HR+/HER2- Breast Cancer
Date of first enrollment	11/06/2026
Target sample size	8
Countries of recruitment	Canada,Japan,Czech Republic,Japan,Denmark,Japan,France,Japan,Germany,Japan,Hong Kong,Japan,Hungary,Japan,Italy,Japan,Korea,Japan,Nethherlands,Japan,Poland,Japan,Portugal,Japan,Singapore,Japan,Spain,Japan,Taiwan,Japan,UK,Japan,United States,Japan
Study type	Interventional
Intervention(s)	Experimental: IEV407 Single Agent Experimental: IEV407 in combination with fulvestrant Experimental: IEV407 in combination with letrozole

Outcome(s)

Primary Outcome	Incidence and severity of dose-limiting toxicities (DLTs) Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) Frequency of dose interruptions, reductions and discontinuations Dose intensity
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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 leaset 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 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.
Exclude 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.