SoGreat is an open-label, single-arm, modular, two-stage, Phase Ib/II study. SoGreat (Part 1) is an open-label, modular, Phase Ib study.
Female or male patients, 18 years of age or older, able to understand and give written informed consent.
ECOG performance status of 0 or 1.
Men, pre-menopausal or perimenopausal women must use gonadotropin-releasing hormone agonists (such as goserelin) in a standardized manner.
bilateral oophorectomy.
Positive serum pregnancy test or women who are breastfeeding.
Women of childbearing potential or fertile men unwilling to use highly effective contraception during the study and up to 6 months after treatment discontinuation in women of childbearing potential and 3 months in males post last IP administration.
Known hypersensitivity to the study drug, its metabolites, or formulation excipient.
Requirement for ongoing therapy with or prior use of any prohibited medications listed in Section 4.2.6.
Hunan Cancer Hospital
Lead sponsor
Gilead Sciences
Collaborator