Tests GV20-0251 in adults with advanced or hard-to-treat solid tumors
Tests GV20-0251 for safety in adults with several advanced solid tumors.
Plain-language title generated from the registry record
Registry title: A Study of GV20-0251 in Advanced or Refractory Solid Tumors
Key facts
- Where
- Chengdu, ChinaSee the site
- Phase
- Phase 1
Where in China
- West China HospitalChengdu, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- West China Hospital
- Trial code
- NCT07106827
- Record updated
- 24 November 2025
- Original description
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.Read full original descriptionShow less
Single Arm Clinical Study Protocol of GV20-0251 in the Treatment of Advanced/Refractory Solid Tumors
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.
Inclusion: 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: Major surgery within 28 days prior to the first dose of study medication; Prior anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) before the first dose of GV20-0251 on Cycle 1 Day 1 (C1D1), with the exceptions; Radiation therapy for symptomatic lesions within 14 days prior to C1D1 dosing; Participant with heart disease, myocardial infarction within the past 6 months, or unstable arrhythmia; 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, known hepatitis B virus (HBV), or hepatitis C virus (HCV) infection, unless meeting the specific conditions; History of major organ transplant and/or a bone marrow transplant; Symptomatic central nervous system (CNS) malignancy or metastasis; Serious nonmalignant disease; History of severe allergic reactions to biologic therapy, which in the investigator's judgment may increase the subject's risk; Any history of an immune-related ≥ Grade 3 AE attributed to prior cancer immunotherapy; 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; Participants with acute leukemia or CLL; Pregnant or nursing women; Active substance abuse.