[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hormone-refractory-prostate-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hormone-refractory-prostate-cancer":84},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,54],{"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,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":61,"minAge":18,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":22,"phases":64,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":83},"100515907","phase-1-safety-pharmacokinetics-and-preliminary-efficacy-of-vir-5500-amx-500-in-prostate-cancer-100515907","NCT05997615","Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer","A Phase 1, First-in-Human Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Participants With Prostate Cancer","Inclusion Criteria:\n\nApplicable to Parts 1 and 2\n\n1. Have metastatic disease, defined by ≥ 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scan imaging\n2. Have documented progressive mCRPC based on ≥ 1 of the criteria (per PCWG3)\n\n   * PSA level ≥ 1 ng\u002FmL that has increased on ≥ 2 successive occasions ≥ 1 week apart\n   * Nodal or visceral progression as defined by RECIST v1.1 with PCWG3 modifications\n   * Appearance of ≥ 2 new lesions in bone scan\n3. Have been treated with ≥ 1 second-generation androgen-signaling inhibitor, including abiraterone, apalutamide, darolutamide, and\u002For enzalutamide\n4. Have been treated with ≥ 1 prior taxane regimens (e.g., docetaxel, cabazitaxel)\n5. Are deemed unsuitable for standard of care\n\nApplicable to Part 2, 3a and Part 4a,\n\n1. Have metastatic CRPC, defined by ≥ 1 metastatic lesion that is present on baseline CT, MRI, or bone scan imaging that has documented progressive disease (PD) based on ≥ 1 of the following criteria (per PCWG3):\n\n   * PSA level ≥ 1 ng\u002FmL that has increased on ≥ 2 successive occasions ≥ 1 week apart\n   * Nodal or visceral progression as defined by RECIST v1.1 with PCWG3 modifications\n   * Appearance of ≥2 new lesions in bone scan\n2. Participants with metastatic hormone sensitive prostate cancer (mHSPC) or with biochemical recurrent prostate cancer (BRPC) may also participate in select cohorts of this clinical trial.\n\nExclusion Criteria:\n\n1. Presence of dominant histopathological features representative of sarcomatoid, spindle cell, or neuroendocrine small cell components\n2. Has acute or chronic infections\n3. Has a concomitant medical or inflammatory condition that may increase the risk of toxicity to VIR-5500 (AMX-500), per the Investigator\n4. Has lesions in proximity of vital organs\n5. Has known active CNS metastases and\u002For carcinomatous meningitis The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","MALE",{"count":63,"type":21},437,[24],"The study will be conducted in 4 parts and will commence with dose escalation of VIR-5500 as a monotherapy (Part 1), followed by combination escalation (Part 3a), monotherapy dose expansion (Part 2) and combination dose expansion (Part 4a).\n\n* Part 1 (Monotherapy Dose Escalation): Single-agent VIR-5500 dose escalation\n* Part 2 (Monotherapy Dose Expansion): Single-agent VIR-5500 dose expansion\n* Part 3 (Combination Dose Escalation): VIR-5500 plus another therapeutic agent dose escalation Part 3a (Combination Dose Escalation): VIR-5500 in combination with an androgen receptor signaling inhibitor (ARSI)\n* Part 4 (Combination Dose Expansion): VIR-5500 plus another therapeutic agent dose expansion Part 4a (Combination Dose Expansion): VIR-5500 in combination with an androgen receptor signaling inhibitor (ARSI)",[67],"Hormone-refractory Prostate Cancer",[69,70,71,72,73],"Prostate Cancer","Castration Resistant Prostatic Cancer","High-Risk Biochemical Recurrent Prostate Cancer","Metastatic Castration-resistant Prostate Cancer (mCRPC)","Hormone Sensitive Prostate Cancer (HSPC)","2026-06-03",{"date":76,"type":45},"2026-06-04",{"date":78,"type":45},"2023-08-10",{"date":80,"type":21},"2027-09-29",{"name":82,"class":52},"Vir Biotechnology, Inc.",12,"Hormone-Refractory Prostate Cancer"]