Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BBI-940 · 1 trial · 3 indications
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...
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BBI-940 is an investigational small molecule being studied for the treatment of advanced or metastatic breast cancer. It is a kinesin oral molecular degrader, and it is currently in Phase 1 clinical development. The drug is not approved and remains under investigation for this oncology indication.
BBI-940 is a kinesin oral molecular degrader. It targets kinesin proteins, which are motor proteins involved in cell division. By degrading these proteins, the drug aims to disrupt cancer cell proliferation. This mechanism is being evaluated in the context of advanced or metastatic breast cancer.
BBI-940 is being developed by Boundless Bio, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol BOLD. The company is conducting clinical research on this investigational drug for the treatment of breast cancer.
BBI-940 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial is designed to evaluate the drug in subjects with advanced or metastatic breast cancer.
BBI-940 is being studied in a Phase 1 clinical trial registered as NCT07408089. The trial is titled "Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer." It was conducted in the United States and enrolled 8 participants, though the trial status is listed as terminated.