This is a Phase 1 non-randomized, open label, multi-center study to be conducted in two parts (Parts A and B).~Part A involves a 3 + 3 dose escalation scheme to evaluate safety and dose limiting toxicities (DLTs) and to establish the maximum tolerated dose (MTD) and/or the recommended Phase 2 (RP2D) of GV20-0251.~Part B is a cohort expansion in which eligible patients will be treated at the RP2D of GV20-0251 to further characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of GV20-0251 as well as to evaluate anti-tumor activity in patients with selected malignancies.~The study consists of a Screening Period, a Treatment Period, an End of Treatment Visit, Safety Follow-Up Period and a Survival Follow-Up Period.
This is a Phase 1 study of GV20-0251 being developed for the treatment of patients with advanced solid tumors, who are refractory to approved therapies or other standard of care.