GV20-0251 treatment for adults with advanced solid tumors
An Open-Label Phase 1/2A Study of GV20-0251 in Participants With Advanced and/or Refractory Solid Tumor Malignancies
This study will test GV20-0251 to see if it helps adults with advanced solid tumors that have stopped responding to approved therapies.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | GV20 Therapeutics Industry-sponsored |
| Drugs / interventions | immunotherapy, Radiation |
| Locations | 3 sites (Beijing, Beijing Municipality and 2 other locations) |
| Trial ID | NCT07070518 on ClinicalTrials.gov |
What this trial studies
This is a Phase 1/2A, open-label, non-randomized, multicenter study conducted in two parts. Part A uses a 3+3 dose-escalation to define the maximum tolerated dose or a recommended Phase 2 dose and monitor early safety. Part B uses a Simon two-stage design with multiple expansion cohorts at the preliminary RP2D to characterize anti-tumor activity, safety, tolerability, pharmacokinetics, and pharmacodynamics. Eligible participants must have measurable, histologically confirmed advanced solid tumors refractory to standard treatments, and Part B participants should be willing to provide pre- and on-treatment tumor biopsies when feasible.
Who should consider this trial
Good fit: Adults aged 18 or older with histologically confirmed advanced solid malignancies that are refractory to or intolerant of standard therapies, measurable disease per RECIST 1.1, ECOG 0–1, and (for Part B) willing to provide fresh tumor biopsies when clinically feasible.
Not a fit: Patients who are responding to approved standard treatments, have poor performance status, significant comorbidities, or cannot undergo required biopsies or follow-up visits are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, GV20-0251 could provide a new treatment option that may shrink tumors or control disease in patients whose cancers are refractory to current therapies.
How similar studies have performed: While some early-phase trials of novel targeted or immune-oncology agents have produced responses in select refractory tumor subsets, GV20-0251 is investigational and human data are limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Beijing Municipality and 2 other locations
- Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)
- Cancer Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (Recruiting)
- Shanghai Pulmonary Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Shanghai Xunbaihui Biotechnology
- Email: clinicaltrials@gv20tx.com
- Phone: +8615800557307
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.