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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06926868 | A Study of Izalontamab Brengitecan Versus Chemotherapy in Participants With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer Ineligible for Anti-PD(L)1 Drugs (IZABRIGHT-Breast01) | PHASE2 | RECRUITING | 500 | — | — | Sep 11, 2025 | May 15, 2030 | May 29, 2026 | 294 | United States, Argentina +26 |
Assessed using Response Evaluation Criteriain Solid Tumors version 1.1 (RECIST v1.1) byblinded independent central review (BICR)
| Arm | Type | Description |
|---|---|---|
| Arm A1 | EXPERIMENTAL | - |
| Arm A2 | EXPERIMENTAL | - |
| Arm B | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Iza-bren | DRUG | Specified dose on specified days |
| Nab-paclitaxel | DRUG | Specified dose on specified days |
| Paclitaxel | DRUG | Specified dose on specified days |
| Capecitabine | DRUG | Specified dose on specified days |
| Carboplatin | DRUG | Specified dose on specified days |
| Gemcitabine | DRUG | Specified dose on specified days |
Inclusion Criteria * Histologically or cytologically confirmed and documented locally-advanced, recurrent inoperable, or metastatic TNBC (ER \< 1%, PgR \< 1%, HER2 IHC 0, 1+, or 2+ with ISH negative for HER2 gene amplification) or ER-low, HER2-negative BC (ER and / or PgR 1% to 10%, HER2 IHC 0, 1+,...