Study of GV20-0251 in Participants With Solid Tumor Malignancies

Launched by GV20 THERAPEUTICS · Jul 16, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new medicine called GV20-0251 to see if it can help adults with advanced solid tumors—types of cancer that form solid masses in the body—who have not responded to standard treatments. The study is in early phases (Phase 1 and 2), focusing on safety and effectiveness. It includes several types of cancers such as lung cancer, colon cancer, melanoma, liver cancer, and others. The goal is to find out if GV20-0251 is safe and if it can help control the disease in people whose cancer has continued to grow despite previous therapies.

Adults 18 years and older with confirmed advanced cancer that has progressed after standard treatments may be eligible. Participants need to have measurable cancer that doctors can track over time and be in relatively good health aside from their cancer. Those who have tried certain immune therapies but whose cancer still grew may also join. People will be asked to sign a consent form, agree to follow the study rules, and may need to provide small tumor samples before and during treatment. The study excludes individuals with certain heart problems, active infections, autoimmune diseases, some infections like HIV or hepatitis unless controlled, recent major surgery, or pregnancy. Participants can expect close monitoring, including tests and scans, to see how they respond to the new treatment and to check for side effects. This trial is currently recruiting people who meet these 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)
• • Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST version 1.1)
• • For participants who have received prior treatment with a checkpoint inhibitor there must be documented disease progression
• • ECOG performance status of 0 or 1 before C1D1
• • Part B Participants must be willing to provide fresh tumor biopsy (core biopsy) both pre-treatment and on-treatment, if clinically feasible
• • 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 (NYHA ≥ Level II), 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 before 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