Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07604571 | Study of IEV407 as Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer | PHASE1 | RECRUITING | 194 | — | — | May 28, 2026 | Jun 8, 2032 | Jun 5, 2026 | 2 | United States, Singapore |
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...