Faeth Therapeutics
The study is a Phase 1b/2, multi-center, open-label, dose escalation trial evaluating the safety and preliminary efficacy of sapanisertib and serabelisib (PIKTOR) with fulvestrant and/or other anticancer therapies in participants with HR+/HER2- advanced/metastatic breast cancer.
The study is a Phase 1b/2, multi-center, open-label, dose escalation trial evaluating the safety and preliminary efficacy of sapanisertib and serabelisib (PIKTOR) with fulvestrant and/or other anticancer therapies in participants with HR+/HER2- advanced/metastatic breast cancer.
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 evaluable target lesion according to RECIST v1.1 * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 at Screening. * Non-pregnant, non-lactating females who are postmenopausal, surgically sterile or who agree to use effective contraceptive methods. Exclusion Criteria: * Participants w…
Serabelisib is a selective, small molecule inhibitor of PI3Kα.
Sapanisertib is a small molecule inhibitor of the mammalian mTOR serine/threonine kinase.
Fulvestrant is a first-in-class SERD.