NCT07106827RecruitingPhase 1
A Study of GV20-0251 in Advanced or Refractory Solid Tumors
Single Arm Clinical Study Protocol of GV20-0251 in the Treatment of Advanced/Refractory Solid Tumors
Source: ClinicalTrials.gov · Last updated 24 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 9 Jul 2025
- Start date
- 4 Sept 2025
- Primary completion date
- 11 Jun 2027
- Lead sponsor
- West China Hospital
- Diseases
- Head and neck cancer, Melanoma, Endometrial cancer, Lung cancer, Pancreatic cancer, Liver and biliary tract cancer
- NCT number
- NCT07106827
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 10
- From 4 Sept 2025 to the primary completion date, 11 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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
Lab values
- 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.
Other
- Participants with acute leukemia or CLL
- Pregnant or nursing women
- Active substance abuse
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| West China Hospital Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.