Testing GV20-0251 for advanced or treatment‑resistant solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single‑center, single‑arm Phase 1 dose‑escalation trial using a 3+3 design to test the safety of GV20-0251 in multiple advanced solid tumor types. Two planned dose levels (10 mg/kg and 20 mg/kg, given every three weeks) will be explored with a 21‑day dose‑limiting toxicity (DLT) observation window. If the maximum tolerated dose (MTD) is not reached at 20 mg/kg, no further escalation will occur. The trial enrolls small cohorts of 3–6 patients per dose level and can include a wide range of tumor indications that are refractory to standard therapies.

Why it matters

Who can join: the full rules

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

Where it's running

• West China Hospital
  Chengdu, Sichuan, China Recruiting

Study contacts

• Study coordinator: Jin Zhou
• Email: zhoujin096@scu.edu.cn
• Phone: +8618980600172

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.