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McKinley Drive","Tampa","33612",{"type":59,"coordinates":127},[128,129],-82.45843,27.94752,{"lat":129,"lon":128},{"facility":132,"status":52,"city":133,"state":134,"zip":135,"country":56,"countryCode":57,"cosmosGeoPoint":136,"geoPoint":140,"contacts":47},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":59,"coordinates":137},[138,139],-71.05977,42.35843,{"lat":139,"lon":138},{"facility":65,"status":52,"city":142,"state":143,"zip":144,"country":56,"countryCode":57,"cosmosGeoPoint":145,"geoPoint":149,"contacts":47},"Rochester","Minnesota","55905",{"type":59,"coordinates":146},[147,148],-92.4699,44.02163,{"lat":148,"lon":147},{"facility":151,"status":52,"city":152,"state":152,"zip":153,"country":56,"countryCode":57,"cosmosGeoPoint":154,"geoPoint":158,"contacts":47},"NYU Langone Health Perlmutter Cancer Center","New York","10016",{"type":59,"coordinates":155},[156,157],-74.00597,40.71427,{"lat":157,"lon":156},{"facility":160,"status":52,"city":152,"state":152,"zip":161,"country":56,"countryCode":57,"cosmosGeoPoint":162,"geoPoint":164,"contacts":47},"Icahn School of Medicine at Mount Sinai","10029",{"type":59,"coordinates":163},[156,157],{"lat":157,"lon":156},{"facility":166,"status":52,"city":152,"state":152,"zip":167,"country":56,"countryCode":57,"cosmosGeoPoint":168,"geoPoint":170,"contacts":47},"Columbia University - The Trustees of Columbia University in the City of New York","10032",{"type":59,"coordinates":169},[156,157],{"lat":157,"lon":156},{"facility":172,"status":52,"city":152,"state":152,"zip":173,"country":56,"countryCode":57,"cosmosGeoPoint":174,"geoPoint":176,"contacts":47},"Montefiore Medical Center","10461",{"type":59,"coordinates":175},[156,157],{"lat":157,"lon":156},{"facility":178,"status":52,"city":142,"state":152,"zip":179,"country":56,"countryCode":57,"cosmosGeoPoint":180,"geoPoint":184,"contacts":47},"University of Rochester Medical Center (URMC) - Wilmot Cancer Institute (WCI) (James P. Wilmot Cancer Center) - Rochester","14642",{"type":59,"coordinates":181},[182,183],-77.61556,43.15478,{"lat":183,"lon":182},{"facility":186,"status":187,"city":188,"state":189,"zip":190,"country":56,"countryCode":57,"cosmosGeoPoint":191,"geoPoint":195,"contacts":47},"Providence Portland Medical Center","WITHDRAWN","Portland","Oregon","97213",{"type":59,"coordinates":192},[193,194],-122.67621,45.52345,{"lat":194,"lon":193},{"facility":197,"status":52,"city":188,"state":189,"zip":198,"country":56,"countryCode":57,"cosmosGeoPoint":199,"geoPoint":201,"contacts":47},"Oregon Health & Science University (3485 S. Bond)","97239",{"type":59,"coordinates":200},[193,194],{"lat":194,"lon":193},{"facility":203,"status":52,"city":204,"state":205,"zip":206,"country":56,"countryCode":57,"cosmosGeoPoint":207,"geoPoint":211,"contacts":47},"Thomas Jefferson University Hospital","Philadelphia","Pennsylvania","19107",{"type":59,"coordinates":208},[209,210],-75.16362,39.95238,{"lat":210,"lon":209},{"facility":213,"status":52,"city":214,"state":215,"zip":216,"country":56,"countryCode":57,"cosmosGeoPoint":217,"geoPoint":221,"contacts":47},"Lifespan Cancer Institute","Providence","Rhode Island","02903",{"type":59,"coordinates":218},[219,220],-71.41283,41.82399,{"lat":220,"lon":219},{"facility":223,"status":52,"city":224,"state":225,"zip":226,"country":56,"countryCode":57,"cosmosGeoPoint":227,"geoPoint":231,"contacts":47},"MD Anderson Cancer Center","Houston","Texas","77030",{"type":59,"coordinates":228},[229,230],-95.36327,29.76328,{"lat":230,"lon":229},{"facility":233,"status":52,"city":234,"state":235,"zip":236,"country":56,"countryCode":57,"cosmosGeoPoint":237,"geoPoint":241,"contacts":47},"Emily Couric Clinical Cancer Center","Charlottesville","Virginia","22908",{"type":59,"coordinates":238},[239,240],-78.47668,38.02931,{"lat":240,"lon":239},{"facility":243,"status":52,"city":244,"state":245,"zip":246,"country":56,"countryCode":57,"cosmosGeoPoint":247,"geoPoint":251,"contacts":47},"West Virginia University","Morgantown","West Virginia","26506",{"type":59,"coordinates":248},[249,250],-79.9559,39.62953,{"lat":250,"lon":249},{"type":253,"investigatorFullName":47,"investigatorTitle":47,"investigatorAffiliation":47,"oldNameTitle":47,"oldOrganization":47},"SPONSOR","100360402","phase-1-a-trial-to-find-out-if-regn5678-nezastomig-is-safe-and-how-well-it-works-alone-or-in-combination-with-cemiplimab-for-adult-participants-with-metastatic-castration-resistant-prostate-cancer-and-other-tumors-100360402",false,"NCT03972657","A Trial to Find Out if REGN5678 (Nezastomig) is Safe and How Well it Works Alone or in Combination With Cemiplimab for Adult Participants With Metastatic Castration-Resistant Prostate Cancer and Other Tumors","A Phase 1\u002F2 Study of REGN5678 (Anti-PSMAxCD28) With or Without Cemiplimab (Anti-PD-1) in Patients With Metastatic Castration-Resistant Prostate Cancer and Other Tumors Associated With PSMA Expression","Key Inclusion Criteria:\n\nmCRPC cohorts (men):\n\n1. Men with histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma.\n2. PSA value at screening ≥4 ng\u002FmL that has progressed within 6 months prior to screening as defined in the protocol.\n3. Has received ≥2 lines prior systemic therapy approved in the metastatic and\u002For castration-resistant setting (in addition to Androgen Deprivation Therapy \\[ADT\\]) including at least:\n\n   1. one second-generation anti-androgen therapy (eg, abiraterone, enzalutamide, apalutamide, or darolutamide)\n   2. 177Lu-PSMA-617 radiotherapy, or another lutetium-based PSMA targeted radioligand, as described in the protocol\n\nccRCC cohorts (men and women):\n\n1. Histologically or cytologically confirmed RCC with a clear-cell component.\n2. Diagnosis of metastatic ccRCC with at least one measurable lesion via RECIST 1.1 criteria\n3. Has progressed on or after ≥1 line prior systemic therapy approved in the metastatic setting. Prior treatment must include an anti-Programmed Death-1 (receptor) \\[PD-1\\]\u002FProgrammed Death-Ligand 1 (PD-L1) therapy and either ipilimumab and\u002For a tyrosine kinase inhibitor\n\nKey Exclusion Criteria:\n\n1. Has received treatment with an approved systemic therapy within 3 weeks of dosing or has not yet recovered (ie, grade ≤1 or baseline) from any acute toxicities, as described in the protocol\n2. Has received any previous systemic biologic therapy within 5 half-lives of first dose of study therapy, as described in the protocol\n3. Has received prior PSMA-targeting therapy with the exception of a PSMA targeting radioligand (eg. 177Lu-PSMA-617) in mCRPC\n4. Dose Escalation: Has had prior anti-cancer immunotherapy (other than sipuleucel-T) within 5 half-lives prior to study therapy.\n5. Dose Expansion (mCRPC only): Has had prior anti-cancer immunotherapy, as described in the protocol\n6. Any condition that requires ongoing\u002Fcontinuous corticosteroid therapy (\\>10 mg prednisone\u002Fday or anti-inflammatory equivalent) within 1 week prior to the first dose of study therapy\n7. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, as described in the protocol\n8. Encephalitis, meningitis, neurodegenerative disease (with the exception of mild dementia that does not interfere with Activities of Daily Living \\[ADLs\\]) or uncontrolled seizures in the year prior to first dose of study therapy\n9. Uncontrolled infection with Human Immunodeficiency Virus (HIV), hepatitis B or hepatitis C infection; or diagnosis of immunodeficiency\n\nNOTE: Other protocol defined Inclusion\u002FExclusion Criteria apply","ALL","18 Years",{"count":264,"type":265},345,"ESTIMATED","INTERVENTIONAL",[268,269],"PHASE1","PHASE2","The main purpose of this study is to determine the safety, tolerability (how the body reacts to the drug\\[s\\]) and effectiveness (ability to treat the cancer) of REGN5678 (Nezastomig) alone, or in combination with cemiplimab.\n\nThe study has 2 parts. The goal of Part 1 (dose escalation) is to determine a safe dose(s) of REGN5678 when it is given alone or in combination with cemiplimab. The goal of Part 2 (dose expansion) is to use the REGN5678 drug dose(s) found in Part 1 to see how well REGN5678 alone or in combination with cemiplimab works to shrink tumors.\n\nThis study is looking at several other research questions, including:\n\n1. Side effects that may be experienced by taking REGN5678 alone or in combination with cemiplimab\n2. How REGN5678 alone or in combination with cemiplimab works in the body\n3. How much REGN5678 and\u002For cemiplimab are present in the blood\n4. To see if REGN5678 alone or in combination with cemiplimab works to reduce the size of the tumor by helping the immune system destroy the tumor",[272,273],"Metastatic Castration-Resistant Prostate Cancer (mCRPC)","Clear Cell Renal Cell Carcinoma (ccRCC)","2026-06-22",{"date":276,"type":277},"2026-06-25","ACTUAL",{"date":279,"type":277},"2019-08-12",{"date":281,"type":265},"2027-11-15",{"name":5,"class":6},22]