[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575644":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":24,"locations":25,"responsibleParty":256,"collaborators":258,"id":261,"slug":262,"hasResults":263,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":263,"sex":269,"minAge":270,"maxAge":24,"enrollmentInfo":271,"targetDuration":24,"studyType":274,"phases":275,"briefSummary":277,"conditions":278,"keywords":24,"overallStatus":28,"whyStopped":24,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":294},{"fullName":5,"class":6},"NextCure, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1 - Dose Escalation and Backfills","EXPERIMENTAL","Aim: Doses of LNCB74 will be escalated to determine the maximum tolerated dose (MTD), maximum administered dose (MAD) and\u002For recommended Phase 2 dose (RP2D). One or more dose levels will be backfilled for safety and additional biomarker data.",[13],"Drug: LNCB74",{"label":15,"type":10,"description":16,"interventionNames":17},"Part 2 - Dose Expansion \u002F Optimization","Aim: The objectives of the Part 2 Dose Expansion\u002FOptimization are: i) to evaluate safety, tolerability, anti-tumor activity, and pharmacodynamics of LNCB74 in a more homogenous population and ii) characterize the minimally safe and effective dose in a particular tumor type and determine recommended Phase 2 dose(s) (RP2D).",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","LNCB74","LNCB74 is an antibody drug conjugate being evaluated as a potential treatment for participants with advanced solid tumors. Participants will receive LNCB74 into the vein (IV; intravenously) in 21-day dosing cycles. Participants will continue treatment in the absence of unacceptable toxicities and unequivocal disease progression.",[9,15],null,[26,49,66,82,99,117,134,151,168,184,201,211,223,240],{"facility":27,"status":28,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Hoag Family Cancer Institute","RECRUITING","Newport Beach","California","92663","United States","US",{"type":35,"coordinates":36},"Point",[37,38],-117.92895,33.61891,{"lat":38,"lon":37},[41,46],{"name":42,"role":43,"phone":44,"phoneExt":24,"email":45},"Holland Orndorff","CONTACT","949- 764- 7110","Holland.Orndorff@hoag.org",{"name":47,"role":48,"phone":24,"phoneExt":24,"email":24},"Monica Mita, MD","PRINCIPAL_INVESTIGATOR",{"facility":50,"status":28,"city":51,"state":52,"zip":53,"country":32,"countryCode":33,"cosmosGeoPoint":54,"geoPoint":58,"contacts":59},"St. Elizabeth Healthcare","Edgewood","Kentucky","41017",{"type":35,"coordinates":55},[56,57],-84.58189,39.01867,{"lat":57,"lon":56},[60,64],{"name":61,"role":43,"phone":62,"phoneExt":24,"email":63},"Sara McCauley","317-519-4251","Sara.McCauley@stelizabeth.com",{"name":65,"role":48,"phone":24,"phoneExt":24,"email":24},"Daniel Flora, MD",{"facility":67,"status":28,"city":68,"state":69,"zip":70,"country":32,"countryCode":33,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Dana Farber Cancer Institute","Boston","Massachusetts","02215",{"type":35,"coordinates":72},[73,74],-71.05977,42.35843,{"lat":74,"lon":73},[77,81],{"name":78,"role":43,"phone":79,"phoneExt":24,"email":80},"Joyce Liu, MD","877-338-7425","Joyce_Liu@DFCI.HARVARD.EDU",{"name":78,"role":48,"phone":24,"phoneExt":24,"email":24},{"facility":83,"status":28,"city":84,"state":85,"zip":86,"country":32,"countryCode":33,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Washington University, Siteman Cancer Center","St Louis","Missouri","63108",{"type":35,"coordinates":88},[89,90],-90.19789,38.62727,{"lat":90,"lon":89},[93,97],{"name":94,"role":43,"phone":95,"phoneExt":24,"email":96},"Siteman Cancer Inst. Information","314-747-1171","MedicalOncologyCallCenter@dom.wustl.edu",{"name":98,"role":48,"phone":24,"phoneExt":24,"email":24},"Dan Morgansztern, MD",{"facility":100,"status":101,"city":102,"state":103,"zip":104,"country":32,"countryCode":33,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"John Theurer Cancer Ctr at Hackensack Univ. Med Ctr.","NOT_YET_RECRUITING","Hackensack","New Jersey","07601",{"type":35,"coordinates":106},[107,108],-74.04347,40.88593,{"lat":108,"lon":107},[111,115],{"name":112,"role":43,"phone":113,"phoneExt":24,"email":114},"Oncology Clinical Research Office","551-996-1777","oncologyresearchreferral@hmhn.org",{"name":116,"role":48,"phone":24,"phoneExt":24,"email":24},"Martin Gutierrez",{"facility":118,"status":28,"city":119,"state":120,"zip":121,"country":32,"countryCode":33,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Roswell Park Comprehensive Cancer Center","Buffalo","New York","14203",{"type":35,"coordinates":123},[124,125],-78.87837,42.88645,{"lat":125,"lon":124},[128,132],{"name":129,"role":43,"phone":130,"phoneExt":24,"email":131},"Roswell Park Information","800-767-9355","Askroswell@rosewellpark.org",{"name":133,"role":48,"phone":24,"phoneExt":24,"email":24},"Emese Zsiros, MD",{"facility":135,"status":28,"city":136,"state":137,"zip":138,"country":32,"countryCode":33,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"Cleveland Clinic Taussig Cancer Institute","Cleveland","Ohio","44195",{"type":35,"coordinates":140},[141,142],-81.69541,41.4995,{"lat":142,"lon":141},[145,149],{"name":146,"role":43,"phone":147,"phoneExt":24,"email":148},"Cancer Group","866-223-8100","TaussigResearch@ccf.org",{"name":150,"role":48,"phone":24,"phoneExt":24,"email":24},"Wen Wee Ma, MD",{"facility":152,"status":28,"city":153,"state":154,"zip":155,"country":32,"countryCode":33,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"Sidney Kimmel Comprehensive Center at Jefferson","Philadelphia","Pennsylvania","19107",{"type":35,"coordinates":157},[158,159],-75.16362,39.95238,{"lat":159,"lon":158},[162,166],{"name":163,"role":43,"phone":164,"phoneExt":24,"email":165},"Phase 1 Unit","215-586-0199","askphase1@jefferson.edu",{"name":167,"role":48,"phone":24,"phoneExt":24,"email":24},"Ida Micaily, MD",{"facility":169,"status":28,"city":170,"state":154,"zip":171,"country":32,"countryCode":33,"cosmosGeoPoint":172,"geoPoint":176,"contacts":177},"UPMC","Pittsburgh","15213",{"type":35,"coordinates":173},[174,175],-79.99589,40.44062,{"lat":175,"lon":174},[178,182],{"name":179,"role":43,"phone":180,"phoneExt":24,"email":181},"Julie Urban","412-623-7396","urbanj2@upmc.edu",{"name":183,"role":48,"phone":24,"phoneExt":24,"email":24},"Julia Foldi, MD",{"facility":185,"status":28,"city":186,"state":187,"zip":188,"country":32,"countryCode":33,"cosmosGeoPoint":189,"geoPoint":193,"contacts":194},"MD Anderson","Houston","Texas","77030",{"type":35,"coordinates":190},[191,192],-95.36327,29.76328,{"lat":192,"lon":191},[195,199],{"name":196,"role":43,"phone":197,"phoneExt":24,"email":198},"Jing Peng","713-792-2208","jingpeng@mdanderson.org",{"name":200,"role":48,"phone":24,"phoneExt":24,"email":24},"Siqing Fu, MD",{"facility":202,"status":203,"city":204,"state":187,"zip":205,"country":32,"countryCode":33,"cosmosGeoPoint":206,"geoPoint":210,"contacts":24},"NEXT Oncology","COMPLETED","San Antonio","78229",{"type":35,"coordinates":207},[208,209],-98.49363,29.42412,{"lat":209,"lon":208},{"facility":212,"status":28,"city":204,"state":187,"zip":205,"country":32,"countryCode":33,"cosmosGeoPoint":213,"geoPoint":215,"contacts":216},"UT Health San Antonio - MD Anderson Cancer Center",{"type":35,"coordinates":214},[208,209],{"lat":209,"lon":208},[217,221],{"name":218,"role":43,"phone":219,"phoneExt":24,"email":220},"Epp Goodwin","210-450-5798","goodwine@uthscsa.edu",{"name":222,"role":48,"phone":24,"phoneExt":24,"email":24},"Daruka Mahadevan",{"facility":224,"status":28,"city":225,"state":226,"zip":227,"country":32,"countryCode":33,"cosmosGeoPoint":228,"geoPoint":232,"contacts":233},"Intermountain\u002FLDS Hospital Ph 1 Research Program","Salt Lake City","Utah","84143",{"type":35,"coordinates":229},[230,231],-111.89105,40.76078,{"lat":231,"lon":230},[234,238],{"name":235,"role":43,"phone":236,"phoneExt":24,"email":237},"Joshua Kunz","801-408-4724","joshua.kunz@imail.org",{"name":239,"role":48,"phone":24,"phoneExt":24,"email":24},"Caroline Nebhan",{"facility":241,"status":28,"city":242,"state":243,"zip":244,"country":32,"countryCode":33,"cosmosGeoPoint":245,"geoPoint":249,"contacts":250},"Inova Schar Cancer Institute","Falls Church","Virginia","22031",{"type":35,"coordinates":246},[247,248],-77.17109,38.88233,{"lat":248,"lon":247},[251,255],{"name":252,"role":43,"phone":253,"phoneExt":24,"email":254},"Raymond Wadlow, MD","571-472-4724","Raymond.Wadlow@inova.org",{"name":252,"role":48,"phone":24,"phoneExt":24,"email":24},{"type":257,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[259],{"name":260,"class":6},"LigaChem Biosciences, Inc.","100575644","phase-1-a-phase-1-study-of-lncb74-in-advanced-solid-tumors-100575644",false,"NCT06774963","A Phase 1 Study of LNCB74 in Advanced Solid Tumors","A Phase 1, Open-label, Dose Escalation and Dose Expansion Study for LNCB74, a B7-H4 Targeted Antibody Drug Conjugate, as Monotherapy in Participants With Advanced Solid Tumors","LNCB74-01","Inclusion Criteria:\n\n1. The participant provides written informed consent\n2. ≥ 18 years of age on day of signing informed consent.\n3. Participant with histologically or cytologically confirmed diagnosis of advanced unresectable and\u002For metastatic solid tumors\n4. A male participant must agree to use contraception and refrain from sperm donation or expecting to father a child\n5. A female participant is eligible to participate if she is not pregnant, not breastfeeding, not a woman of childbearing potential\n6. Have measurable disease per RECIST 1.1 as assessed by the local site investigator\u002Fradiology\n7. Able to provide tumor tissue sample.\n8. Willing to undergo fresh tumor biopsy at Screening and On-treatment if archival tissue not available\n9. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\n10. Life expectancy greater than or equal to 12 weeks as judged by the Investigator.\n11. Have adequate organ function\n\nExclusion Criteria:\n\n1. A WOCBP who has a positive serum pregnancy test (within 72 hours) prior to treatment.\n2. Has received prior investigational agents within 4 weeks prior to treatment.\n3. Has received anti-cancer chemotherapy (Immunotherapy (non-antibody-based therapy), retinoid therapy, hormonal therapy within 2 weeks prior to treatment.\n4. Has received antibody-based anti-cancer therapy within 4 weeks prior to treatment.\n5. Has received targeted agents and small molecules within 2 weeks or 5 half-lives, whichever is longer.\n6. Has received prior platinum-based chemotherapy and progressed within 4 weeks of initiating therapy (platinum-refractory disease)\n7. Has received an ADC with MMAE payload.\n8. Has received prior radiotherapy within 2 weeks of start of study treatment for focal radiation or within 4 weeks for wide-field radiotherapy\n9. Has received G-CSF or GM-CSF within 7 days prior to start of study treatment.\n10. Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention.\n11. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug\n12. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years\n13. Has known active CNS metastases and\u002For carcinomatous meningitis\n14. Has severe hypersensitivity (≥ Grade 3), known allergy or reaction LNCB74 or any of its excipients.\n15. Has a history of (non-infectious) pneumonitis \u002F interstitial lung disease that required steroids or has current pneumonitis \u002F interstitial lung disease.\n16. Has active ≥Grade 2 sensory or motor neuropathy.\n17. Has active or chronic corneal disorders, other active ocular conditions requiring ongoing therapy or any clinically significant corneal disease.\n18. Has an active infection requiring systemic therapy.\n19. Any major surgery within 4 weeks of study drug administration.\n20. Toxicity (except for alopecia) related to prior anti-cancer therapy and\u002For surgery, unless the toxicity is either resolved, returned to baseline or Grade 1, or deemed irreversible.\n21. Prior organ or tissue allograft.\n22. Uncontrolled or significant cardiovascular disease\n23. Participants with serious or uncontrolled medical disorders.\n24. Participants who are on total parenteral nutrition (TPN)\n25. Participants with history of bowel obstruction within one month of screening\n26. Participants with history of significant ascites requiring paracentesis within 2 weeks of screening\n27. Has a known history of human immunodeficiency virus (HIV) infection with an acquired immune deficiency syndrome (AIDS)-defining opportunistic infection within the last year, or a current CD4 count \\\u003C350 cells\u002Fµl\n28. Has known active Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection\n29. Has a history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study\n30. Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study","ALL","18 Years",{"count":272,"type":273},145,"ESTIMATED","INTERVENTIONAL",[276],"PHASE1","This is an open-label, phase 1, dose escalation and dose expansion study to determine safety and tolerability, and to determine the maximum tolerated dose and \u002F or recommended phase 2 dose of LNCB74 in participants with advanced solid tumors.",[279,280,281,282,283,284],"Ovarian Cancer","Breast Cancer","Endometrial Cancer","Biliary Tract Cancer","Non-Small Cell Lung Cancer","Advanced or Metastatic Solid Tumors","2025-12-08",{"date":287,"type":288},"2025-12-16","ACTUAL",{"date":290,"type":288},"2025-01-07",{"date":292,"type":273},"2026-12",{"name":5,"class":6},14]