An open-label, multi-center, phase I/II study of GVV858 as a single agent and in combination with endocrine therapy in patients with advanced hormone receptor positive, HER2-negative breast cancer and other advanced solid tumors

Advanced HR+/HER- breast cancer

Phase I: Safety: Incidence and severity of dose-limiting toxicities (DLTs), adverse events (AEs) and serious adverse events (SAEs), including changes in lab values, vital signs, electrocardiograms (ECGs). Tolerability: Frequency of dose interruptions, reductions, discontinuations, dose intensity., Phase II: Safety: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), including changes in lab values, vital signs, electrocardiograms (ECGs). Tolerability: Frequency of dose interruptions, reductions, discontinuations, dose intensity.

Phase II: ORR, BOR, DCR, CBR, PFS and duration of response (DOR) per investigator assessment of RECIST v1.1. Plasma concentrations of GVV858 and derived PK parameters (e.g., AUC, Tmax, and Cmax)., Phase I: Plasma concentrations of GVV858 and derived PK parameters (e.g., AUC, Tmax, Cmax). ORR, BOR, DCR, CBR, and PFS per investigator assessment of response evaluation criteria in solid tumors (RECIST v1.1), or local PCWG3 criteria including PCWG3-modified RECIST v1.1 (prostate cancer patients only).

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