This is a single-arm, single-center study for multiple tumor indications to evaluate the safety of GV20-0251. The trial uses a 3 + 3 design and enrolls 3-6 patients in the 10 mg/kg and 20 mg/kg dose groups, respectively. The cancer types include solid tumors.
Before conducting any study-specific procedures, voluntarily sign an informed consent form.
Be able and willing to participate throughout the entire study period and comply with study procedures.
participants ≥18 years of age
Previously treated, histologically-confirmed advanced solid malignancy with progressive disease requiring therapy (Refractory or intolerant to standard therapies, must have received the standard of care therapy)
Participants with acute leukemia or CLL
Participant with heart disease, myocardial infarction within the past 6 months, or unstable arrhythmia
Fridericia-corrected QT interval (QTcF) > 470 msec, or the presence of congenital long QT syndrome, or a history of clinically significant electrocardiogram (ECG) abnormalities (including pericarditis) that, in the investigator's judgment, may affect the subject's safety.
Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy within 7 days of Cycle 1 Day 1 (C1D1)
Single group
GV20-0251
DrugIncreasing doses of GV20-0251 administered by intravenous (IV) infusion once every 3 weeks
Evaluate GV20-0251 safety
Safety should be evaluated according to CTCAE5.0
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West China Hospital
Lead sponsor
GV20 Therapeutics
Collaborator
