Clinical trial · Interventional
A Study of GV20-0251 in Advanced or Refractory Solid Tumors
Single Arm Clinical Study Protocol of GV20-0251 in the Treatment of Advanced/Refractory Solid Tumors
NCT07106827CI-TRIAL-00097756recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| HCC - Hepatocellular Carcinoma | — | UNRESOLVED | — |
| HNSCC | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| NSCLC (Non-small Cell Lung Cancer) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
| Pancreatic Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Testicular Cancer | Malignant Testicular Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GV20-0251 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GV20-0251 Treatment
- description
- GV20-0251 safety in Advanced/Refractory Solid Tumors
- interventionNames
- Drug: GV20-0251
Primary outcomes (1)
- measure
- Evaluate GV20-0251 safety
- timeFrame
- From Cycle 1 Day 1 dosing (each cycle is 21 days) until meeting the study termination criteria or 2 years
- description
- Safety should be evaluated according to CTCAE5.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDLi Y, Wu X, Sheng C, Liu H, Liu H, Tang Y, Liu C, Ding Q, Xie B, Xiao X, Zheng R, Yu Q, Guo Z, Ma J, Wang J, Gao J, Tian M, Wang W, Zhou J, Jiang L, Gu M, Shi S, Paull M, Yang G, Yang W, Landau S, Bao X, Hu X, Liu XS, Xiao T. IGSF8 is an innate immune checkpoint and cancer immunotherapy target. Cell. 2024 May 23;187(11):2703-2716.e23. doi: 10.1016/j.cell.2024.03.039. Epub 2024 Apr 23. PMID 38657602