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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 for the treatment of HR+ HER2- advanced or metastatic breast cancer. It is currently in Phase 1 clinical development, and its safety and efficacy have not been established. The drug is not yet approved by regulatory authorities.
Serabelisib is a small molecule that targets PI3K, a key enzyme in the PI3K/AKT/mTOR signaling pathway, which is often dysregulated in cancer. By inhibiting this target, Serabelisib aims to disrupt tumor cell growth and survival. This mechanism is being evaluated in the context of HR+ HER2- breast cancer.
Serabelisib is being developed by Sensei Biotherapeutics, Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with HR+ HER2- advanced or metastatic breast cancer. Sensei Biotherapeutics is publicly traded under the ticker symbol FTH.
Serabelisib is currently in Phase 1 clinical development. It is being studied in an ongoing clinical trial that is recruiting participants. The drug is investigational and has not been approved by the FDA or any other regulatory agency. Its safety and efficacy are still being evaluated.
Serabelisib is being studied in a Phase 1 clinical trial with the identifier NCT07558733. The trial, titled "Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced/Metastatic Breast Cancer," is currently recruiting participants in the United States. The trial is enrolling 32 patients aged 18 years and older.
Serabelisib is sometimes referred to as PIKTOR in the context of the clinical trial. The trial title includes "PIKTOR" as a shorthand for the combination of sapanisertib and serabelisib. However, Serabelisib is the specific drug name, and PIKTOR is not an alternative name for the drug itself.