A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-5829 as a Monotherapy in Subjects with Advanced Solid Tumors and Lymphomas and in combination with Exemestane or Fulvestrant in Subjects with Estrogen Recep
Charactierize the safety and tolerability of GS-5829 as a monotherapy in subjects with advanced solid tumors and lymphomas Determine the maximum tolerated dose (MTD) or recommended dose for phase 2 (RDP2) of GS-5829 as a monotherapy in subjects with advanced solid tumors and lymphomas characterize the safety and tolerability of GS-5829 in combination with exemestane or fulvestrant in subjects with advanced estrogen receptor positive breast cancer Determine the MTD or RDP2 of GS-5829 in combination with exemestane or fulvestrant in subjects with advanced estrogen receptor positive breast cancer Secondary Obj: Evaluate the pharmacokinetics (PK) of GS-5829 alone in subjects with advanced solid tumors and lymphomas and in combination with exemestance or fulvestrant in subjects with advanced estrogen receptor positive breast cancer Exploratory Obj: Evaluate exploratory pharmacodynamic (PD) , predictive, and prognostic biomarkers associated with disease prognosis and/or benefit from GS-5829 Evaluate the preliminary efficacy of GS-5829 as a monotherapy in subjects with advanced stage solid tumors as measured by overall response rate (ORR) Evaluate the preliminary efficacy of GS-5829 as a monotherapy in subjects with relapsed or refractory aggressive lymphomas (diffuse large B cell lymphoma (DLBCL), or peripheral T cell lymphoma (PTCL) as measured by ORR Evaluate the preliminary efficacy of GS-5829 in combination with exemestane or fulvestrant in subjects with advanced estrogen recptor positive breast cancer as measured by ORR Evaluate the preliminary efficacy of GS-5829 as a monotherapy in subjects with advanced stage solid tumors as measured by progression-freee survival (PFS) Evaluate the preliminary efficacy of GS-5829 as a monotherapy in subjects with relapsed or refractory lymphomas (DLBC or PTCL) as measured by PFS Evaluate the preliminary efficacy of GS-5829 in combination with exemestane or fulvestrant in subjecs with advanced estrogen receptor positive breast cancer as measured by PFS.