[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647108":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":28,"responsibleParty":86,"collaborators":19,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":90,"sex":96,"minAge":97,"maxAge":19,"enrollmentInfo":98,"targetDuration":19,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":117,"overallStatus":31,"whyStopped":19,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"SHY Therapeutics","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SHY-ONC6","EXPERIMENTAL","Participants receive SHY-ONC6 administered orally once daily. Phase 1a, sequential dose levels are evaluated under accelerated titration and BOIN dose-escalation design. In Phase 1b, participants will be evaluated in disease-specific expansion cohorts and receive SHY-ONC6 at the RP2D range identified in Phase 1a.",[13],"Drug: SHY-ONC6",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Participants receive SHY-ONC6 administered orally once daily in 21-day cycles. SHY-ONC6 will be administered until the participant withdraws from study, experiences unacceptable toxicity or other safety event, or their disease progresses.",[9],null,[21,26],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Medical Monitor","CONTACT","914-543-6110","shyonc6@shytherapeutics.com",{"name":27,"role":23,"phone":19,"phoneExt":19,"email":25},"Clinical Operations",[29,47,61,74],{"facility":30,"status":31,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"HonorHealth Research Institute","RECRUITING","Scottsdale","Arizona","85258","United States","US",{"type":38,"coordinates":39},"Point",[40,41],-111.89903,33.50921,{"lat":41,"lon":40},[44],{"name":45,"role":46,"phone":19,"phoneExt":19,"email":19},"Justin Moser, MD","PRINCIPAL_INVESTIGATOR",{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":35,"countryCode":36,"cosmosGeoPoint":53,"geoPoint":57,"contacts":58},"SCRI at HCA HealthONE","NOT_YET_RECRUITING","Denver","Colorado","80218",{"type":38,"coordinates":54},[55,56],-104.9847,39.73915,{"lat":56,"lon":55},[59],{"name":60,"role":46,"phone":19,"phoneExt":19,"email":19},"Gerald Falchook, MD",{"facility":62,"status":49,"city":63,"state":64,"zip":65,"country":35,"countryCode":36,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"The University of Texas MD Anderson Cancer Center","Houston","Texas","77030",{"type":38,"coordinates":67},[68,69],-95.36327,29.76328,{"lat":69,"lon":68},[72],{"name":73,"role":46,"phone":19,"phoneExt":19,"email":19},"Timothy Yap, MBBS, PhD",{"facility":75,"status":31,"city":76,"state":64,"zip":77,"country":35,"countryCode":36,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"NEXT Oncology","San Antonio","78229",{"type":38,"coordinates":79},[80,81],-98.49363,29.42412,{"lat":81,"lon":80},[84],{"name":85,"role":46,"phone":19,"phoneExt":19,"email":19},"Ildefonso Rodriguez Rivera, MD",{"type":87,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100647108","a-study-of-shy-onc6-a-novel-proteasome-inhibitor-in-adults-with-advanced-or-metastatic-solid-tumors-100647108",false,"NCT07705334","A Study of SHY-ONC6, a Novel Proteasome Inhibitor, in Adults With Advanced or Metastatic Solid Tumors","A Phase 1 Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SHY-ONC6 in Participants With Advanced or Metastatic Solid Tumors","Luca-1","Inclusion Criteria:\n\n* Male or female ≥18 years of age.\n* Life expectancy \\>3 months.\n* ECOG performance status 0-1.\n* Histologically\u002Fcytologically confirmed advanced or metastatic solid tumors that have progressed on or are intolerant\u002Funsuitable for standard therapies. Eligible tumor types: TNBC, HR+ breast cancer, colon cancer, gastric cancer, HCC, NSCLC (adeno and squamous), mesothelioma, pancreatic cancer, HRPC, soft tissue sarcoma; other tumor types after Medical Monitor discussion. Stable CNS metastases ≥4 weeks post-radiotherapy and off steroids ≥14 days are permitted.\n* ≥1 measurable lesion per RECIST v1.1 (prostate cancer with bone-only disease and elevated PSA assessed by PCWG3).\n* Accessible tumor for biopsy\n* Adequate organ\u002Fbone marrow function.\n* Willingness and ability to provide informed consent.\n* Negative serum pregnancy test and use of effective contraception through 90 days after last dose for women of childbearing potential.\n* Male participants must use barrier contraception or abstinence and not donate sperm through 90 days after last dose.\n\nExclusion Criteria:\n\n* High-risk cardiovascular disease.\n* Concurrent anti-cancer treatment.\n* Active infection requiring systemic treatment within 2 weeks pre-dose.\n* History of another malignancy (with standard exceptions for in situ disease, non-melanoma skin cancers, and remission ≥2 years).\n* Active HBV (HBV-DNA \\>ULN), HCV (HCV-RNA \\>ULN), or HIV (well-controlled HIV with CD4 ≥350 cells\u002FµL and undetectable viral load permitted); AIDS-defining opportunistic infection within 12 months.\n* Compromised pulmonary function within 6 months pre-dose .\n* Pregnancy or breastfeeding.\n* Recent radiotherapy, systemic anti-tumor therapy, other investigational therapy without appropriate washout.\n* Major surgery ≤4 weeks pre-dose.\n* Unable to swallow tablets or conditions affecting GI absorption.\n* Any medical or psychiatric disorders affecting compliance and\u002For interpretation of study results.\n* Persistent toxicities from prior anti-cancer therapy (exceptions apply)\n* Clinically significant corneal disease.\n* Unable to comply with prohibited concomitant medication restrictions.","ALL","18 Years",{"count":99,"type":100},30,"ESTIMATED","INTERVENTIONAL",[103],"PHASE1","This is a Phase 1, first-in-human (FIH), open-label, multicenter study designed to evaluate the safety, tolerability, PK, and preliminary anti-tumor activity of SHY-ONC6 in participants with advanced or metastatic solid tumors who have progressed on or are intolerant to standard therapies. The study will consist of 2 parts: a dose escalation part (Phase 1a) and a dose expansion part (Phase 1b).",[106,107,108,109,110,111,112,113,114,115,116],"Advanced or Metastatic Solid Tumors","Triple Negative Breast Cancer (TNBC)","HR+ Breast Cancer","Colon Cancer","Gastric Cancer","Hepatecellular Carcinoma","NSCLC (Advanced Non-small Cell Lung Cancer)","Mesothelioma","Pancreatic Carcinoma Metastatic","Hormone Refractory Prostate Cancer","Soft Tissue Sarcomas",[118,119],"Proteasome Inhibitor","Solid Tumors","2026-08-06",{"date":122,"type":123},"2026-08-10","ACTUAL",{"date":125,"type":123},"2026-06-24",{"date":127,"type":100},"2028-05-15",{"name":5,"class":6},4]