NCT07106827 A Study of GV20-0251 in Advanced or Refractory Solid Tumors
| NCT ID | NCT07106827 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | West China Hospital |
| Condition | HCC - Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-09-04 |
| Primary Completion | 2027-06-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2025-09-04 with a primary completion date of 2027-06-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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, 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 * Pregnant or nursing women * 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. * History of severe allergic reactions to biologic therapy, which in the investigator's judgment may increase the subject's risk. * Radiation therapy for symptomatic lesions within 14 days prior to C1D1 dosing. * Active substance abuse * Any history of an immune-related ≥ Grade 3 AE attributed to prior cancer immunotherapy
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07106827 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HCC - Hepatocellular Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07106827 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07106827 currently recruiting?
Yes, NCT07106827 is actively recruiting participants. Contact the research team at zhoujin096@scu.edu.cn for enrollment information.
Where is the NCT07106827 trial being conducted?
This trial is being conducted at Chengdu, China.
Who is sponsoring the NCT07106827 clinical trial?
NCT07106827 is sponsored by West China Hospital. The trial plans to enroll 10 participants.
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