Tests GV20-0251 in adults with advanced solid tumors that stopped responding to treatment

Trial details

Who runs it

GV20 Therapeutics

Trial code

NCT07070518

Record updated

3 December 2025

Original description

This is a Phase 1 and Phase 2 study of GV20-0251 being developed for the treatment of participants with advanced solid tumors, who are refractory to approved therapies or other standard of care.Read full original descriptionShow less

An Open-Label Phase 1/2A Study of GV20-0251 in Participants With Advanced and/or Refractory Solid Tumor Malignancies

This is a Phase 1 and Phase 2 study of GV20-0251 being developed for the treatment of participants with advanced solid tumors, who are refractory to approved therapies or other standard of care.

Inclusion: 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: Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy within 7 days before C1D1; 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; Participant with heart disease (NYHA ≥ Level II), myocardial infarction within the past 6 months, or unstable arrhythmia; 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; 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; Participants with acute leukemia or CLL; Pregnant or nursing women; Active substance abuse.

ClinicalTrials.gov NCT07070518