KURRENT-HN is a Phase 1/2 open-label, combination, dose escalation study of tipifarnib, a farnesyltransferase inhibitor, and alpelisib, a PI3K inhibitor, to determine the safety and recommended dose and regimen for the treatment of adult patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) whose tumors overexpress the HRAS protein and/or are PIK3CA-mutated and/or PIK3CA-amplified. The codependency of HRAS and PI3K pathways in driving tumor growth provides the rationale for a combination trial of tipifarnib and alpelisib in this subset of HNSCC patients.1


Tipifarnib is an oral investigational monotherapy drug candidate for HRAS-mutant HNSCC. In preclinical models, tipifarnib blocks the activity of an enzyme called farnesyltransferase (FT). It is the only farnesyltransferase inhibitor (FTI) under investigation for HRAS-dependent HNSCC2-4.

Alpelisib is an oral inhibitor of phosphatidylinositol-3-kinase (PI3K) with inhibitory activity predominantly against PI3Kα. It received FDA approval as PIQRAY®, a kinase inhibitor indicated in combination with fulvestrant for the treatment of postmenopausal women and men with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen. Important Safety Information can be found here.5


For more information, please email: KO-TIP-013@kuraoncology.com.
To connect with a medical science liaison (MSL), please email: medicalaffairs@kuraoncology.com.


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