[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100490692":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":33,"centralContacts":47,"locations":52,"responsibleParty":235,"collaborators":237,"id":240,"slug":241,"hasResults":242,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":33,"eligibilityCriteria":246,"healthyVolunteers":242,"sex":247,"minAge":248,"maxAge":33,"enrollmentInfo":249,"targetDuration":33,"studyType":252,"phases":253,"briefSummary":256,"conditions":257,"keywords":265,"overallStatus":55,"whyStopped":33,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":275},{"fullName":5,"class":6},"GV20 Therapeutics","INDUSTRY",[8,14,18,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A - Dose Escalation in up to 7 dose levels","EXPERIMENTAL","A 3+3 dose escalation scheme will be used to evaluate the safety and tolerability of GV20-0251, and to establish the maximum tolerated dose (MTD) or the preliminary recommended Phase 2 dose (RP2D).",[13],"Biological: GV20-0251",{"label":15,"type":10,"description":16,"interventionNames":17},"Part B - Multiple Expansion Cohorts in up to 4 tumor indications","The Bayesian optimal design for Phase II (BOP2) will be utilized to further characterize the anti-tumor activities, safety, tolerability, pharmacokinetics, and pharmacodynamics of GV20-0251 at the preliminary RP2D in up to 4 expansion cohorts involving eligible participants.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Part C - GV20-0251 in Combination with Pembrolizumab Dose Escalation in 2-4 dose levels","The Bayesian optimal interval (BOIN) design will be employed to evaluate the safety and tolerability of GV20-0251 in combination with pembrolizumab, and to determine the MTD or the preliminary RP2D of this combination in selected tumor indications.",[22],"Biological: GV20-0251 and Pembrolizumab [KEYTRUDA®]",{"label":24,"type":10,"description":25,"interventionNames":26},"Part D - GV20-0251 in Combination with Pembrolizumab Dose Expansion in up to 5 indications","The BOP2 will be applied to further characterize the anti-tumor activities, safety, tolerability, pharmacokinetics, and pharmacodynamics of GV20-0251 in combination with pembrolizumab at the preliminary RP2D in up to 5 expansion cohorts involving eligible participants.",[22],[28,34,37,43],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"BIOLOGICAL","GV20-0251","Increasing doses of GV20-0251 administered by intravenous (IV) infusion once or twice every 3 weeks as monotherapy.",[9],null,{"type":29,"name":30,"description":35,"armGroupLabels":36,"otherNames":33},"GV20-0251 preliminary RP2D administered by IV infusion as monotherapy.",[15],{"type":29,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"GV20-0251 and Pembrolizumab [KEYTRUDA®]","GV20-0251 administered by IV infusion at 10 mg\u002Fkg once every 3 weeks or at increasing doses up to the preliminary RP2D determined in Part A. 200 mg pembrolizumab administered by IV infusion once every 3 weeks.",[19],[42],"MK-3475",{"type":29,"name":38,"description":44,"armGroupLabels":45,"otherNames":46},"GV20-0251 administered by IV infusion at preliminary RP2D from Part C. 200 mg pembrolizumab administered by IV infusion once every 3 weeks.",[24],[42],[48],{"name":5,"role":49,"phone":50,"phoneExt":33,"email":51},"CONTACT","617-256-2846","clinicaltrials@gv20tx.com",[53,72,87,101,115,129,143,157,170,184,198,212,221],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"The Angeles Clinic and Research Institute","RECRUITING","Los Angeles","California","90025","United States","US",{"type":62,"coordinates":63},"Point",[64,65],-118.24368,34.05223,{"lat":65,"lon":64},[68,69],{"name":5,"role":49,"phone":33,"phoneExt":33,"email":51},{"name":70,"role":71,"phone":33,"phoneExt":33,"email":33},"Kristopher Wentzel, MD","PRINCIPAL_INVESTIGATOR",{"facility":73,"status":74,"city":75,"state":76,"zip":77,"country":59,"countryCode":60,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"HealthONE Clinic Services Oncology - Hematology, LLC d\u002Fb\u002Fa Sarah Cannon Research Institute at HealthONE","NOT_YET_RECRUITING","Denver","Colorado","80218",{"type":62,"coordinates":79},[80,81],-104.9847,39.73915,{"lat":81,"lon":80},[84,85],{"name":5,"role":49,"phone":33,"phoneExt":33,"email":51},{"name":86,"role":71,"phone":33,"phoneExt":33,"email":33},"Jason Henry, MD",{"facility":88,"status":55,"city":89,"state":90,"zip":91,"country":59,"countryCode":60,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Yale University","New Haven","Connecticut","06511",{"type":62,"coordinates":93},[94,95],-72.92816,41.30815,{"lat":95,"lon":94},[98,99],{"name":5,"role":49,"phone":33,"phoneExt":33,"email":51},{"name":100,"role":71,"phone":33,"phoneExt":33,"email":33},"Patricia LoRusso, DO",{"facility":102,"status":74,"city":103,"state":104,"zip":105,"country":59,"countryCode":60,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Florida Cancer Specialists & Research Institute, LLC","Fort Myers","Florida","33916",{"type":62,"coordinates":107},[108,109],-81.84059,26.62168,{"lat":109,"lon":108},[112,113],{"name":5,"role":49,"phone":33,"phoneExt":33,"email":51},{"name":114,"role":71,"phone":33,"phoneExt":33,"email":33},"Judy Wang, MD",{"facility":116,"status":55,"city":117,"state":118,"zip":119,"country":59,"countryCode":60,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Community Health Network, Inc.","Indianapolis","Indiana","46256",{"type":62,"coordinates":121},[122,123],-86.15804,39.76838,{"lat":123,"lon":122},[126,127],{"name":5,"role":49,"phone":33,"phoneExt":33,"email":51},{"name":128,"role":71,"phone":33,"phoneExt":33,"email":33},"Bert O'Neil, MD",{"facility":130,"status":55,"city":131,"state":132,"zip":133,"country":59,"countryCode":60,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":62,"coordinates":135},[136,137],-71.05977,42.35843,{"lat":137,"lon":136},[140,141],{"name":5,"role":49,"phone":33,"phoneExt":33,"email":51},{"name":142,"role":71,"phone":33,"phoneExt":33,"email":33},"Justin Gainor, MD",{"facility":144,"status":55,"city":145,"state":146,"zip":147,"country":59,"countryCode":60,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center","Detroit","Michigan","48201",{"type":62,"coordinates":149},[150,151],-83.04575,42.33143,{"lat":151,"lon":150},[154,155],{"name":5,"role":49,"phone":33,"phoneExt":33,"email":51},{"name":156,"role":71,"phone":33,"phoneExt":33,"email":33},"M. Najeeb Al Hallak, MD",{"facility":158,"status":55,"city":159,"state":159,"zip":160,"country":59,"countryCode":60,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"NYU Langone Health","New York","10016",{"type":62,"coordinates":162},[163,164],-74.00597,40.71427,{"lat":164,"lon":163},[167,168],{"name":5,"role":49,"phone":33,"phoneExt":33,"email":51},{"name":169,"role":71,"phone":33,"phoneExt":33,"email":33},"Janice Mehnert, MD",{"facility":171,"status":55,"city":172,"state":173,"zip":174,"country":59,"countryCode":60,"cosmosGeoPoint":175,"geoPoint":179,"contacts":180},"Oregon Health & Science University","Portland","Oregon","97239",{"type":62,"coordinates":176},[177,178],-122.67621,45.52345,{"lat":178,"lon":177},[181,182],{"name":5,"role":49,"phone":33,"phoneExt":33,"email":51},{"name":183,"role":71,"phone":33,"phoneExt":33,"email":33},"Shivaani Kummar, MD",{"facility":185,"status":74,"city":186,"state":187,"zip":188,"country":59,"countryCode":60,"cosmosGeoPoint":189,"geoPoint":193,"contacts":194},"Verdi Oncology Tennessee, Scri Oncology Partners","Nashville","Tennessee","37203",{"type":62,"coordinates":190},[191,192],-86.78444,36.16589,{"lat":192,"lon":191},[195,196],{"name":5,"role":49,"phone":33,"phoneExt":33,"email":51},{"name":197,"role":71,"phone":33,"phoneExt":33,"email":33},"Meredith Pelster, MD",{"facility":199,"status":55,"city":200,"state":201,"zip":202,"country":59,"countryCode":60,"cosmosGeoPoint":203,"geoPoint":207,"contacts":208},"Oncology Consultants, P.A.","Houston","Texas","77030",{"type":62,"coordinates":204},[205,206],-95.36327,29.76328,{"lat":206,"lon":205},[209,210],{"name":5,"role":49,"phone":33,"phoneExt":33,"email":51},{"name":211,"role":71,"phone":33,"phoneExt":33,"email":33},"Jose Peguero, MD",{"facility":213,"status":55,"city":200,"state":201,"zip":202,"country":59,"countryCode":60,"cosmosGeoPoint":214,"geoPoint":216,"contacts":217},"The University of Texas M. D. Anderson Cancer Center",{"type":62,"coordinates":215},[205,206],{"lat":206,"lon":205},[218,219],{"name":5,"role":49,"phone":33,"phoneExt":33,"email":51},{"name":220,"role":71,"phone":33,"phoneExt":33,"email":33},"Aung Naing, MD",{"facility":222,"status":55,"city":223,"state":224,"zip":225,"country":59,"countryCode":60,"cosmosGeoPoint":226,"geoPoint":230,"contacts":231},"Virginia Cancer Specialists","Fairfax","Virginia","22031",{"type":62,"coordinates":227},[228,229],-77.30637,38.84622,{"lat":229,"lon":228},[232,233],{"name":5,"role":49,"phone":33,"phoneExt":33,"email":51},{"name":234,"role":71,"phone":33,"phoneExt":33,"email":33},"Alexander Spira, MD",{"type":236,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR",[238],{"name":239,"class":6},"Merck Sharp & Dohme LLC","100490692","phase-1-a-study-of-gv20-0251-monotherapy-and-gv20-0251-in-combination-with-pembrolizumab-in-participants-with-solid-tumor-malignancies-100490692",false,"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","ALL","18 Years",{"count":250,"type":251},365,"ESTIMATED","INTERVENTIONAL",[254,255],"PHASE1","PHASE2","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.",[258,259,260,261,262,263,264],"Solid Tumor, Adult","Refractory Cancer","Endometrial Carcinoma (EC)","Squamous Head and Neck Carcinoma","pMMR\u002FMSS Adenocarcinoma of the Colon or Rectum","Cutaneous Melanoma","Non-Small Cell Lung Cancer",[30],"2025-02-11",{"date":268,"type":269},"2025-02-13","ACTUAL",{"date":271,"type":269},"2023-03-23",{"date":273,"type":251},"2027-09-05",{"name":5,"class":6},13]