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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07408089 | Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer | PHASE1 | RECRUITING | 96 | — | — | Feb 25, 2026 | May 31, 2029 | Apr 13, 2026 | 8 | United States |
DLTs will be assessed during the first 28 days of study treatment (Cycle 1) to establish the maximum tolerated dose (MTD) and the recommended dose for expansion (RDE) of BBI-940 as monotherapy.
Incidence of treatment emergent adverse events (TEAEs) will be assessed by maximum severity and maximum causality.
The incidence of study treatment discontinuation and/or interruption will be assessed.
| Arm | Type | Description |
|---|---|---|
| Parts 1A, 1B. BBI-940 Monotherapy Escalation | EXPERIMENTAL | Participants receive BBI-940 given alone in multiple sequential dose escalation cohorts. BBI-940 is given orally in repeated 28-day cycles. |
| Part 2A. BBI-940 in Combination with Fulvestrant (ER+/HER2- Breast Cancer without an ESR1 Mutation) | EXPERIMENTAL | Participants receive BBI-940 in combination with fulvestrant. BBI-940 is given orally in repeated 28-day cycles at one of multiple potential dose levels. |
| Part 2B. BBI-940 Monotherapy Expansion (ER+/HER2- Breast Cancer with FGFR1 Amplification) | EXPERIMENTAL | Participants receive BBI-940 given alone at the recommended dose for expansion (RDE). BBI-940 is given orally in repeated 28-day cycles. |
| Part 2C. BBI-940 Monotherapy Expansion (TNBC-LAR) | EXPERIMENTAL | Participants receive BBI-940 given alone at the recommended dose for expansion (RDE). BBI-940 is given orally in repeated 28-day cycles. |
| Name | Type | Description |
|---|---|---|
| BBI-940 | DRUG | Oral small molecule degrader targeting Kinesin. |
| Fulvestrant | DRUG | Selective estrogen receptor degrader administered intramuscularly. |
Key Inclusion Criteria * Adults with locally advanced or metastatic breast cancer, including estrogen receptor-positive/human epidermal growth factor receptor 2-negative (ER+/HER2-) disease or triple-negative breast cancer with luminal androgen receptor subtype (TNBC-LAR; androgen receptor expressi...