A Study of GV20-0251 in Patients With Solid Tumor Malignancies

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.

Inclusion Criteria:>= 18 years of agepreviously treated, histologically-confirmed advanced solid malignancy with progressive disease requiring therapyrefractory or intolerant to standard therapy(ies)one or more metastatic solid tumors that are evaluable or measurable per RECIST v1.1ECOG performance status of 0 or 1Life expectancy of >=12 weeksDisease-free of active second/secondary or prior malignancies for ≥ 2 yearslaboratory test results within the required parametersWomen of child bearing potential (WOCBP) and men must agree to use adequate contraceptionExclusion Criteria:Patients with hematologic malignanciesPatients with heart disease or unstable arrhythmiaActive, uncontrolled bacterial, viral, or fungal infections requiring systemic therapyKnown human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C infectionHistory of major organ transplantHistory of a bone marrow transplantSymptomatic central nervous system (CNS) malignancy or metastasisSerious nonmalignant diseasePregnant or nursing womenTreatment with PD-1 and equivalent immune modulators or major surgery prior to the first dose of study medicationPatients who are currently receiving any other investigational agent or have received an investigational agent within 4 weeks prior to the first dose of study medicationTreatment with any anticancer treatments with 2-weeks prior to the first dose of study medicationRadiation for symptomatic lesions must have been completed prior to the first dose of study medicationActive substance abuse