[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"SHY Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":54},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":38,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"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":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"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).",[27,28,29,30,31,32,33,34,35,36,37],"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",[39,40],"Proteasome Inhibitor","Solid Tumors","RECRUITING","2026-08-06",{"date":44,"type":45},"2026-08-10","ACTUAL",{"date":47,"type":45},"2026-06-24",{"date":49,"type":21},"2028-05-15",{"name":51,"class":52},"SHY Therapeutics","INDUSTRY",4,""]