[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"squamous-head-and-neck-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:squamous-head-and-neck-carcinoma":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100598363","phase-1-study-of-gv20-0251-in-participants-with-solid-tumor-malignancies-100598363",false,"NCT07070518","Study of GV20-0251 in Participants With Solid Tumor Malignancies","An Open-Label Phase 1\u002F2A Study of GV20-0251 in Participants With Advanced and\u002For Refractory Solid Tumor Malignancies","Inclusion Criteria:\n\n* Before conducting any study-specific procedures, voluntarily sign an informed consent form.\n* Be able and willing to participate throughout the entire study period and comply with study procedures.\n* participants ≥18 years of age\n* 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)\n* Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST version 1.1)\n* For participants who have received prior treatment with a checkpoint inhibitor there must be documented disease progression\n* ECOG performance status of 0 or 1 before C1D1\n* Part B Participants must be willing to provide fresh tumor biopsy (core biopsy) both pre-treatment and on-treatment, if clinically feasible\n* Disease-free of active second\u002Fsecondary or prior malignancies for ≥ 2 years Laboratory test results within the required parameters\n* Women of childbearing potential (WOCBP) and men must agree to use adequate contraception\n\nExclusion Criteria:\n\n* Participants with acute leukemia or CLL\n* Participant with heart disease (NYHA ≥ Level II), myocardial infarction within the past 6 months, or unstable arrhythmia\n* 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.\n* Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy within 7 days before C1D1\n* Participant has active autoimmune disease or other medical conditions requiring chronic systemic steroid or immunosuppressive therapy\n* Known human immunodeficiency virus (HIV) infection, known hepatitis B virus (HBV), or hepatitis C virus (HCV) infection, unless meeting the specific conditions.\n* History of major organ transplant and\u002For a bone marrow transplant\n* Symptomatic central nervous system (CNS) malignancy or metastasis\n* Serious nonmalignant disease\n* Pregnant or nursing women\n* Major surgery within 28 days prior to the first dose of study medication\n* 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.\n* History of severe allergic reactions to biologic therapy, which in the investigator's judgment may increase the subject's risk.\n* Radiation therapy for symptomatic lesions within 14 days prior to C1D1 dosing.\n* Active substance abuse\n* Any history of an immune-related ≥ Grade 3 AE attributed to prior cancer immunotherapy","ALL","18 Years",{"count":19,"type":20},350,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","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.",[27,28,29,30,31,32,33,34,35],"Solid Tumor Cancer","Adult Refractory Cancer","Endometrial Carcinoma (EC)","Squamous Head and Neck Carcinoma","pMMR\u002FMSS Adenocarcinoma of the Colon or Rectum","Non-Small Cell Lung Cancer","Melanoma","HCC - Hepatocellular Carcinoma","Small Cell Lung Cancer","RECRUITING","2025-12-01",{"date":39,"type":40},"2025-12-03","ACTUAL",{"date":42,"type":40},"2025-07-11",{"date":44,"type":20},"2028-09-16",{"name":46,"class":47},"GV20 Therapeutics","INDUSTRY",3,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100490692","phase-1-a-study-of-gv20-0251-monotherapy-and-gv20-0251-in-combination-with-pembrolizumab-in-participants-with-solid-tumor-malignancies-100490692","NCT05669430","A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Solid Tumor Malignancies","An Open-Label Phase 1\u002F2A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Advanced and\u002For Refractory Solid Tumor Malignancies","Inclusion Criteria:\n\n* Participants ≥18 years of age\n* Previously treated, histologically-confirmed advanced solid malignancy with progressive disease requiring therapy\n* Refractory or intolerant to standard therapy(ies)\n* Must have received, be not eligible or decline standard of care therapy\n* Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST version 1.1)\n* For participants who have received prior treatment with a checkpoint inhibitor there must be documented disease progression\n* ECOG performance status of 0 or 1\n* Life expectancy of ≥ 12 weeks in Parts A and C and ≥ 24 weeks in Parts B and D\n* Participants must be willing to provide fresh tumor biopsy (core biopsy) both pre-treatment (Parts A, B, C and D) and on-treatment (Parts A and B), if clinically feasible\n* Disease-free of active second\u002Fsecondary or prior malignancies for ≥ 2 years\n* Laboratory test results within the required parameters\n* Women of child bearing potential (WOCBP) and men must agree to use adequate contraception\n* Parts B, C and D may include the following tumor types:\n\n  * Endometrial carcinoma\n  * Squamous head and neck carcinoma\n  * Cutaneous melanoma\n  * Non-small cell lung cancer\n  * Proficient MMR (pMMR)\u002FMSS adenocarcinoma of the colon or rectum (Parts C and D only)\n\nParts A, B, C and D Exclusion Criteria:\n\n* Participant with acute leukemia or CLL (Parts A and B only)\n* Participant with heart disease or unstable arrhythmia\n* Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy\n* Participant has active autoimmune disease or other medical conditions requiring chronic systemic steroid or immunosuppressive therapy\n* History of major organ transplant\n* History of a bone marrow transplant\n* Symptomatic central nervous system (CNS) malignancy or metastasis\n* Serious nonmalignant disease\n* Pregnant or nursing women\n* Treatment with PD-1 and equivalent immune modulators or major surgery prior to the first dose of study medication\n* Participants who are currently receiving any other investigational agent or have received an investigational agent within 4 weeks prior to the first dose of study medication\n* Treatment with any anticancer treatments with 2-weeks prior to the first dose of study medication\n* Radiation for symptomatic lesions must have been completed prior to the first dose of study medication\n* Participants with liver metastases unless approved by the Sponsor\n* Any history of an immune related ≥ Grade 3 AE attributed to prior cancer immunotherapy\n* Has a known additional malignancy that is progressing or has required active treatment within the past 2 years from C1D1\n* Has received radiation therapy to the lung that is higher than 30 Gy within 6 months prior to C1D1 for NSCLC (Parts C and D only)\n* Has a known additional malignancy that is progressing or has required active treatment within the past 2 years from C1D1 (Parts C and D only)\n* Has severe hypersensitivity ( ≥ Grade 3) to Pembrolizumab and\u002For any of its excipients (Parts C and D only)\n* Has a history of (non-infectious) pneumonitis \u002F interstitial lung disease that required steroids or has current pneumonitis \u002F interstitial lung disease (Parts C and D only)\n* Has a condition, therapy, laboratory abnormality, or circumstance that could confound study results or interfere with full participation, making it unsuitable for the participant, as determined by the treating Investigator (Parts C and D only)\n* Active substance abuse",{"count":57,"type":20},365,[23,24],"This is a Phase 1\u002F2A 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.",[61,62,29,30,31,63,32],"Solid Tumor, Adult","Refractory Cancer","Cutaneous Melanoma",[65],"GV20-0251","2025-02-11",{"date":68,"type":40},"2025-02-13",{"date":70,"type":40},"2023-03-23",{"date":72,"type":20},"2027-09-05",{"name":46,"class":47},13]