Study of IEV407 for Advanced HR+/HER2- Breast Cancer
This study is testing a new medication called IEV407, given by mouth, for people with advanced hormone receptor-positive (HR+), HER2-negative (HER2-) breast cancer. Researchers want to see how safe IEV407 is, how well people tolerate it, and if it shows early signs of helping to treat the cancer. IEV407 will be given alone or in combination with approved medications, fulvestrant (an injection) or letrozole (a pill). You may be eligible if you are at least 18 years old and your cancer has progressed after certain previous treatments. The study will measure side effects and how often doses need to be changed or stopped to understand the safety of the treatment.
- Study design
- This is a first-in-human, open-label study, meaning both you and your doctors will know which treatment you are receiving. It will involve approximately 194 participants and includes a dose escalation and expansion part.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored for up to approximately 2 years after starting the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study of IEV407 as Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer
At a glance
Conditions
Where it's being run
5 sites across 5 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- 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 discontinuationsUp to approximately 2 years
Number of participants with dose adjustments (interruptions, reductions, or permanent discontinuation) as a measure of tolerability.
- Dose intensityUp to approximately 2 years
Dose intensity defined as the ratio of actual cumulative dose received and actual duration of exposure.