A Study of GV20-0251 in Advanced or Refractory Solid Tumors

Launched by WEST CHINA HOSPITAL · Jul 29, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called GV20-0251 for people with advanced or hard-to-treat solid tumors, which are cancers that form lumps or masses in the body. The study is focused on several types of cancer, including liver cancer (hepatocellular carcinoma), bile duct cancer (cholangiocarcinoma), skin cancer (melanoma), lung cancer (non-small cell lung cancer), pancreatic cancer, head and neck cancer, endometrial (uterine) cancer, and testicular cancer. The main goal of the trial is to see if GV20-0251 is safe to use and to find the right dose for future studies.

People who might join this study are adults (18 years or older) whose cancer has progressed despite previous treatments or who cannot tolerate standard therapies. Participants need to be in relatively good health to take part, with a performance status that shows they can carry out daily activities without too much difficulty. Before joining, they must agree to follow all study rules and sign a consent form. During the trial, patients will receive GV20-0251 and be closely monitored for side effects and overall health. It’s important to know that this is an early-phase study, meaning the main focus is safety, so the treatment’s effectiveness is still being explored. Also, the trial is not currently recruiting participants but will be looking for eligible adults of any gender who meet specific health criteria.

Gender

ALL

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