Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Serabelisib · 1 trial · 1 indication
Graded according to the National Cancer Institute (NCI CTCAE v5.0).
| Arm | Type | Description |
|---|---|---|
| Cohort A1 - Sapanisertib and serabelisib (PIKTOR) with fulvestrant | EXPERIMENTAL | Subjects will receive doses of sapanisertib and serabelisib (PIKTOR) administered orally and fulvestrant administered intramuscularly. |
| Cohort A2 - Sapanisertib and serabelisib (PIKTOR) with fulvestrant | EXPERIMENTAL | Subjects will receive doses of sapanisertib and serabelisib (PIKTOR) at a higher dose than Cohort A1 administered orally and fulvestrant administered intramuscularly. |
| Name | Type | Description |
|---|---|---|
| Serabelisib | DRUG | Serabelisib is a selective, small molecule inhibitor of PI3Kα. |
| Sapanisertib | DRUG | Sapanisertib is a small molecule inhibitor of the mammalian mTOR serine/threonine kinase. |
| Fulvestrant | DRUG | Fulvestrant is a first-in-class SERD. |
Inclusion Criteria: * Histologically confirmed diagnosis of HR+/HER2- breast cancer. * Documented evidence of advanced or recurrent disease that is not amenable to surgery/radiation for curative intent. * Participant has received at least one prior systemic therapy. * At least 1 measurable or evalu...
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Serabelisib is an investigational small molecule being studied in HR-positive, HER2-negative breast cancer, including advanced and metastatic disease. It is being evaluated in a Phase 1 clinical trial in combination with sapanisertib in various combinations. It is not approved for any indication and remains in clinical development.
Serabelisib targets PIK3CA, the gene encoding the p110 alpha catalytic subunit of phosphatidylinositol 3-kinase. It acts as an inhibitor of this target. The trial in HR-positive, HER2-negative breast cancer is biomarker selected, meaning patients are chosen based on relevant molecular characteristics.
Serabelisib is being developed by Faeth Therapeutics, Inc., which trades under the ticker FTH. The company is running the clinical program for this asset in HR-positive, HER2-negative breast cancer.
Serabelisib is in Phase 1 clinical development. It is investigational and has not been approved by the FDA for any indication. The ongoing study is a Phase 1 trial evaluating the drug in combination regimens in patients with HR-positive, HER2-negative advanced or metastatic breast cancer.
Serabelisib is being studied in one active clinical trial, NCT07558733, titled Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced/Metastatic Breast Cancer. The trial is currently recruiting, is controlled, is not randomized or double blinded, and plans to enroll 32 participants in the United States.