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

Recruiting now · Phase 1

Conditions studied: HCC - Hepatocellular Carcinoma, Cholangiocarcinoma, Melanoma, NSCLC (Non-small Cell Lung Cancer), Pancreatic Ductal Adenocarcinoma, HNSCC, Endometrial Cancer, Testicular Cancer

In brief

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.

Key facts

Study ID: NCT07106827
Run by: West China Hospital
People needed: 10
Starts: 2025-09-04
Expected to finish: 2028-06-11
Last updated by the study team: 2025-11-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 it is running

West China Hospital — Chengdu, Sichuan, China (enrolling)

Full record on ClinicalTrials.gov

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