A Study of GV20-0251 in Advanced or Refractory Solid Tumors (NCT07106827) | Clinical Trial Compass
RecruitingPhase 1
A Study of GV20-0251 in Advanced or Refractory Solid Tumors
China10 participantsStarted 2025-09-04
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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)
* ECOG performance status of 0 or 1 before C1D1
* Disease-free of active second/secondary or prior malignancies for ≥ 2 years Laboratory test results within the required parameters
* Women of childbearing potential (WOCBP) and men must agree to use adequate contraception
Exclusion Criteria:
* 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)
* Participant has active autoimmune disease or other medical conditions requiring chronic systemic steroid or immunosuppressive therapy
* Known human immunodeficiency virus (HIV) infection,…
What they're measuring
1
Evaluate GV20-0251 safety
Timeframe: From Cycle 1 Day 1 dosing (each cycle is 21 days) until meeting the study termination criteria or 2 years