An Open-Label Study of GV20-0251 in Patients With Advanced and/or Refractory Solid Tumor Malignancies

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.

Inclusion Criteria:

• >= 18 years of age
• previously treated, histologically-confirmed advanced solid malignancy with progressive disease requiring therapy
• refractory or intolerant to standard therapy(ies)
• one or more metastatic solid tumors that are evaluable or measurable per RECIST v1.1
• ECOG performance status of 0 or 1
• Life expectancy of >=12 weeks
• Disease-free of active second/secondary or prior malignancies for ≥ 2 years
• laboratory test results within the required parameters
• Women of child bearing potential (WOCBP) and men must agree to use adequate contraception

Exclusion Criteria:

• Participant with acute luekemia or CLL
• Participant with heart disease or unstable arrhythmia
• Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy
• Participant has active autoimmune disease or other medical conditions requiring chronic systemic steroid or immunosuppressive therapy
• Known human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C infection
• History of major organ transplant
• History of a bone marrow transplant
• Symptomatic central nervous system (CNS) malignancy or metastasis
• Serious nonmalignant disease
• Pregnant or nursing women
• Treatment with PD-1 and equivalent immune modulators or major surgery prior to the first dose of study medication
• Participants who are currently receiving any other investigational agent or have received an investigational agent within 4 weeks prior to the first dose of study medication
• Treatment with any anticancer treatments with 2-weeks prior to the first dose of study medication
• Radiation for symptomatic lesions must have been completed prior to the first dose of study medication
• Active substance abuse