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 studied for the treatment of advanced HR+/HER2- breast cancer. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being evaluated as a single agent and in combination with other therapies for this patient population.
IEV407 is being developed by Novartis AG, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker symbol NVS. Novartis is conducting clinical trials to evaluate the safety and efficacy of IEV407 in patients with advanced HR+/HER2- breast cancer.
IEV407 is currently in Phase 1 clinical development. The drug is being studied in an ongoing clinical trial that is recruiting participants. As an investigational agent, IEV407 has not yet received approval from regulatory authorities and remains in the early stages of clinical evaluation.
IEV407 is being evaluated in a Phase 1 clinical trial with the identifier NCT07604571. This study is investigating IEV407 as a single agent or in combination with other therapies in patients with advanced HR+/HER2- breast cancer. The trial is currently recruiting participants and has a planned enrollment of 194 patients.
No alternative names for IEV407 have been disclosed in the available clinical trial information. The drug is identified solely by its investigational name IEV407 in the ongoing Phase 1 study. It is being developed by Novartis AG for the treatment of advanced HR+/HER2- breast cancer.