Testing GV20-0251 for advanced or treatment‑resistant solid tumors
Single Arm Clinical Study Protocol of GV20-0251 in the Treatment of Advanced/Refractory Solid Tumors
This study will test whether GV20-0251 is safe and tolerable when given every three weeks to adults with advanced or treatment‑resistant solid tumors such as liver, lung, pancreatic cancer, and melanoma.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | West China Hospital Academic / other |
| Drugs / interventions | immunotherapy, Radiation |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT07106827 on ClinicalTrials.gov |
What this trial studies
This is a single‑center, single‑arm Phase 1 dose‑escalation trial using a 3+3 design to test the safety of GV20-0251 in multiple advanced solid tumor types. Two planned dose levels (10 mg/kg and 20 mg/kg, given every three weeks) will be explored with a 21‑day dose‑limiting toxicity (DLT) observation window. If the maximum tolerated dose (MTD) is not reached at 20 mg/kg, no further escalation will occur. The trial enrolls small cohorts of 3–6 patients per dose level and can include a wide range of tumor indications that are refractory to standard therapies.
Who should consider this trial
Good fit: Adults (≥18 years) with histologically confirmed, advanced solid malignancies that are refractory or intolerant to standard treatments, who have ECOG performance status 0–1 and meet required laboratory and contraception rules, are the intended candidates.
Not a fit: Patients with active leukemia/CLL, significant recent cardiac events or unstable arrhythmia, prolonged QTcF (>470 ms), poor performance status, or those who cannot comply with study visits are unlikely to benefit or are ineligible.
Why it matters
Potential benefit: If successful, GV20-0251 could provide a new treatment option for people with advanced solid tumors that no longer respond to standard therapies.
How similar studies have performed: This is an early Phase 1 safety trial for GV20-0251 with limited prior clinical data for this specific agent, although 3+3 dose‑escalation designs have been commonly and successfully used for other targeted oncology agents.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chengdu, Sichuan
- West China Hospital — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Study coordinator: Jin Zhou
- Email: zhoujin096@scu.edu.cn
- Phone: +8618980600172
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.