Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IEV407 · 1 trial · 1 indication
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.
Number of participants with AEs and SAEs, including changes in laboratory values, vital signs and echocardiograms (ECGs) qualifying and reported as AEs.
Number of participants with dose adjustments (interruptions, reductions, or permanent discontinuation) as a measure of tolerability.
Dose intensity defined as the ratio of actual cumulative dose received and actual duration of exposure.
| Arm | Type | Description |
|---|---|---|
| Dose escalation: IEV407 single agent | EXPERIMENTAL | IEV407 single agent |
| Dose escalation: IEV407 + fulvestrant | EXPERIMENTAL | IEV407 in combination with fulvestrant |
| Dose escalation: IEV407 + letrozole | EXPERIMENTAL | IEV407 in combination with letrozole |
| Dose expansion, recommended dose (RD)-1: IEV407 + fulvestrant | EXPERIMENTAL | IEV407 in combination with fulvestrant |
| Dose expansion, RD-2 (optional dose optimization): IEV407 + fulvestrant | EXPERIMENTAL | IEV407 in combination with fulvestrant |
| Name | Type | Description |
|---|---|---|
| IEV407 | DRUG | Oral administration |
| Fulvestrant | DRUG | Intramuscular injection. Approved medication. |
| Letrozole | DRUG | Oral administration. Approved medication. |
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...
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IEV407 is an investigational small molecule being developed by Novartis AG for advanced HR+/HER2- breast cancer, a form of hormone receptor positive, HER2 negative breast cancer. It is currently in Phase 1 clinical development and is not yet approved for any indication.
IEV407 is being studied for the treatment of advanced HR+/HER2- breast cancer, meaning hormone receptor positive and HER2 negative disease. It is an investigational therapy in Phase 1 testing, so it is not yet available as an approved treatment outside of clinical trials.
IEV407 is being developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor of the clinical program evaluating the compound in advanced HR+/HER2- breast cancer.
IEV407 is in Phase 1 clinical development. It is an investigational small molecule and has not been approved by the FDA or any other regulatory agency. The Phase 1 program is currently recruiting participants with advanced HR+/HER2- breast cancer.
IEV407 is being evaluated in one clinical trial, NCT07604571, titled a study of IEV407 as a single agent or in combination in patients with advanced HR+/HER2- breast cancer. The trial is currently recruiting, is randomized and controlled, and plans to enroll 194 participants across the United States, Canada, France, Japan, Singapore, and South Korea.