Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:31 AM
Ignite Modification Date:
2025-12-25 @ 4:31 AM
NCT ID:
NCT07070518
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07070518
Study Brief:
Protocol Section:
NCT07070518