[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100471052":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":46,"centralContacts":50,"locations":56,"responsibleParty":363,"collaborators":365,"id":368,"slug":369,"hasResults":370,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":54,"eligibilityCriteria":374,"healthyVolunteers":370,"sex":375,"minAge":376,"maxAge":54,"enrollmentInfo":377,"targetDuration":54,"studyType":380,"phases":381,"briefSummary":384,"conditions":385,"keywords":392,"overallStatus":59,"whyStopped":54,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":410},{"fullName":5,"class":6},"Blue Earth Therapeutics Ltd","INDUSTRY",[8,15,19,23,27],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase 1, Cohort A","EXPERIMENTAL","Subjects with PSMA positive disease will receive 5.55GBq of 177Lu-rhPSMA-10.1 (maximum of 3 cycles).",[13,14],"Drug: Lutetium (177Lu) rhPSMA-10.1 Injection","Diagnostic Test: 18F-rhPSMA-7.3 injection (in phase 1 only)",{"label":16,"type":10,"description":17,"interventionNames":18},"Phase 1, Cohort B","Subjects with PSMA positive disease will receive 7.4GBq of 177Lu-rhPSMA-10.1 (maximum of 3 cycles).",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Phase 2, Cohort 2A","Subjects with PSMA positive disease will receive 2 doses at 10.00 GBq (270 mCi) followed by up to 5 additional doses at 7.40 GBq (200 mCi), all doses administered at 6-weekly intervals.",[13],{"label":24,"type":10,"description":25,"interventionNames":26},"Phase 2, Cohort 2B","Subjects with PSMA positive disease will receive up to 8 doses at 7.40 GBq (200 mCi). The first 3 doses will be administered at 3-weekly intervals, with the remaining doses being administered at 6-weekly intervals.",[13],{"label":28,"type":10,"description":29,"interventionNames":30},"Phase 2, Cohort 2C (optional)","If opened, subjects with PSMA positive disease will receive 2 doses at 14.80 GBq (400 mCi) followed by up to 4 additional doses at 7.40 GBq (200 mCi), all doses administered at 6-weekly intervals.",[13],[32,39],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"DRUG","Lutetium (177Lu) rhPSMA-10.1 Injection","Therapeutic cycles of 177Lu-rhPSMA-10.1",[9,16,20,24,28],[38],"177Lu-rhPSMA-10.1",{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"DIAGNOSTIC_TEST","18F-rhPSMA-7.3 injection (in phase 1 only)","18F-rhPSMA-7.3 (in phase 1 only) at an administered activity of 296 MBq (8 mCi) for PET\u002FCT scan to ascertain whether the subject has PSMA-positive disease.",[9,16],[45],"18F-rhPSMA-7.3 (in phase 1 only)",[47],{"name":48,"affiliation":48,"role":49},"Blue Earth Therapeutics","STUDY_DIRECTOR",[51],{"name":48,"role":52,"phone":53,"phoneExt":54,"email":55},"CONTACT","+44 (0)1865 634500",null,"contact@blueearthTx.com",[57,79,92,113,130,140,156,170,183,198,211,223,236,252,265,281,295,309,323,336,349],{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Biogenix Molecular LLC","RECRUITING","Miami","Florida","33165","United States","US",{"type":66,"coordinates":67},"Point",[68,69],-80.19366,25.77427,{"lat":69,"lon":68},[72,76],{"name":73,"role":52,"phone":74,"phoneExt":54,"email":75},"Jerry Joseph","786-791-1799","jjoseph@cira-health.com",{"name":77,"role":78,"phone":54,"phoneExt":54,"email":54},"Cesar Santana, MD","PRINCIPAL_INVESTIGATOR",{"facility":80,"status":59,"city":60,"state":61,"zip":81,"country":63,"countryCode":64,"cosmosGeoPoint":82,"geoPoint":84,"contacts":85},"NovaCure Health","33176",{"type":66,"coordinates":83},[68,69],{"lat":69,"lon":68},[86,90],{"name":87,"role":52,"phone":88,"phoneExt":54,"email":89},"Anibal Munguia Midence","786-485-0770","amunguia@novacurehealth.com",{"name":91,"role":78,"phone":54,"phoneExt":54,"email":54},"Serguei Castaneda, MD",{"facility":93,"status":59,"city":94,"state":95,"zip":96,"country":63,"countryCode":64,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Emory University Hospital","Atlanta","Georgia","30322",{"type":66,"coordinates":98},[99,100],-84.38798,33.749,{"lat":100,"lon":99},[103,107,111],{"name":104,"role":52,"phone":105,"phoneExt":54,"email":106},"David Michael Schuster","404-778-5625","dschust@emory.edu",{"name":108,"role":52,"phone":109,"phoneExt":54,"email":110},"Nashwa Jarkas","404-727-2193","njarkas@emory.edu",{"name":112,"role":78,"phone":54,"phoneExt":54,"email":54},"David Michael Schuster, MD",{"facility":114,"status":59,"city":115,"state":116,"zip":117,"country":63,"countryCode":64,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"XCancer Omaha \u002F Urology Cancer Center","Omaha","Nebraska","68130",{"type":66,"coordinates":119},[120,121],-95.94043,41.25626,{"lat":121,"lon":120},[124,128],{"name":125,"role":52,"phone":126,"phoneExt":54,"email":127},"Nordquist","(402) 991-8468","drnordquist@gucancer.com",{"name":129,"role":78,"phone":54,"phoneExt":54,"email":54},"Luke Nordquist, MD",{"facility":131,"status":132,"city":133,"state":133,"zip":134,"country":63,"countryCode":64,"cosmosGeoPoint":135,"geoPoint":139,"contacts":54},"Weill Cornell Medicine - New York - Presbyterian Hospital","COMPLETED","New York","10065",{"type":66,"coordinates":136},[137,138],-74.00597,40.71427,{"lat":138,"lon":137},{"facility":141,"status":59,"city":142,"state":54,"zip":143,"country":144,"countryCode":145,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"Saint Luc University Hospital","Brussels","1200","Belgium","BE",{"type":66,"coordinates":147},[148,149],4.34878,50.85045,{"lat":149,"lon":148},[152],{"name":153,"role":52,"phone":154,"phoneExt":54,"email":155},"Emmanuel Seront","+32 (2764) 51 06","emmanuel.seront@saintluc.uclouvain.be",{"facility":157,"status":59,"city":158,"state":54,"zip":159,"country":144,"countryCode":145,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"University Hospital Ghent","Ghent","9000",{"type":66,"coordinates":161},[162,163],3.71667,51.05,{"lat":163,"lon":162},[166],{"name":167,"role":52,"phone":168,"phoneExt":54,"email":169},"Charles van Praet","+32 (9) 332 1955","charles.vanpraet@uzgent.be",{"facility":171,"status":59,"city":172,"state":54,"zip":54,"country":144,"countryCode":145,"cosmosGeoPoint":173,"geoPoint":177,"contacts":178},"University Hospital Leuven","Leuven",{"type":66,"coordinates":174},[175,176],4.70093,50.87959,{"lat":176,"lon":175},[179],{"name":180,"role":52,"phone":181,"phoneExt":54,"email":182},"Karolien Goffin","+32 16 34 37 15","karolien.goffin@uzleuven.be",{"facility":184,"status":59,"city":185,"state":54,"zip":54,"country":186,"countryCode":187,"cosmosGeoPoint":188,"geoPoint":192,"contacts":193},"University Hospital Aachen","Aachen","Germany","DE",{"type":66,"coordinates":189},[190,191],6.08342,50.77664,{"lat":191,"lon":190},[194],{"name":195,"role":52,"phone":196,"phoneExt":54,"email":197},"Felix Mottaghy","+49 241 80-35905","fmottaghy@ukaachen.de",{"facility":199,"status":59,"city":200,"state":54,"zip":54,"country":186,"countryCode":187,"cosmosGeoPoint":201,"geoPoint":205,"contacts":206},"Universitätsklinikum Augsburg","Augsburg",{"type":66,"coordinates":202},[203,204],10.89851,48.37154,{"lat":204,"lon":203},[207],{"name":208,"role":52,"phone":209,"phoneExt":54,"email":210},"Constantin Lapa","0821 400 -168952","constantin.lapa@uk-augsburg.de",{"facility":212,"status":59,"city":213,"state":54,"zip":54,"country":186,"countryCode":187,"cosmosGeoPoint":214,"geoPoint":218,"contacts":219},"University Hospital Essen","Essen",{"type":66,"coordinates":215},[216,217],7.01228,51.45657,{"lat":217,"lon":216},[220],{"name":221,"role":52,"phone":54,"phoneExt":54,"email":222},"Boris Hadaschik","boris.hadaschik@uk-essen.de",{"facility":224,"status":59,"city":225,"state":54,"zip":54,"country":186,"countryCode":187,"cosmosGeoPoint":226,"geoPoint":230,"contacts":231},"Hospital Rechts der Isar","Munich",{"type":66,"coordinates":227},[228,229],11.57549,48.13743,{"lat":229,"lon":228},[232],{"name":233,"role":52,"phone":234,"phoneExt":54,"email":235},"Matthias Eiber","+49 (89) 41404549","matthias.eiber@tum.de",{"facility":237,"status":59,"city":238,"state":239,"zip":240,"country":241,"countryCode":242,"cosmosGeoPoint":243,"geoPoint":247,"contacts":248},"Radboud UMC","Nijmegen","Gelderland","6525GA","Netherlands","NL",{"type":66,"coordinates":244},[245,246],5.85278,51.8425,{"lat":246,"lon":245},[249],{"name":250,"role":52,"phone":54,"phoneExt":54,"email":251},"Nagarajah, MD","james.nagarajah@radboudumc.nl",{"facility":253,"status":59,"city":254,"state":54,"zip":54,"country":241,"countryCode":242,"cosmosGeoPoint":255,"geoPoint":259,"contacts":260},"Meander Medisch Centrum","Amersfoort",{"type":66,"coordinates":256},[257,258],5.3875,52.155,{"lat":258,"lon":257},[261],{"name":262,"role":52,"phone":263,"phoneExt":54,"email":264},"Joyce van Dodewaard-de Jong","033-850 7278","jm.van.dodewaard@meandermc.nl",{"facility":266,"status":59,"city":267,"state":54,"zip":268,"country":269,"countryCode":270,"cosmosGeoPoint":271,"geoPoint":275,"contacts":276},"Bristol Hematology and Oncology Center","Bristol","BS2 8ED","United Kingdom","UK",{"type":66,"coordinates":272},[273,274],-2.59665,51.45523,{"lat":274,"lon":273},[277],{"name":278,"role":52,"phone":279,"phoneExt":54,"email":280},"Amarnath Challapalli, MD","+44 (0) 117 923 0000","Amarnath.Challapalli@uhbw.nhs.uk",{"facility":282,"status":59,"city":283,"state":54,"zip":284,"country":269,"countryCode":270,"cosmosGeoPoint":285,"geoPoint":289,"contacts":290},"Beatson West of Scotland Cancer Center","Glasgow","G12 0YN",{"type":66,"coordinates":286},[287,288],-4.25763,55.86515,{"lat":288,"lon":287},[291],{"name":292,"role":52,"phone":293,"phoneExt":54,"email":294},"David Colville","+44 (0) 141 301 7000","dave.colville@glasgow.ac.uk",{"facility":296,"status":59,"city":297,"state":54,"zip":298,"country":269,"countryCode":270,"cosmosGeoPoint":299,"geoPoint":303,"contacts":304},"St Bartholomew's Hospital","London","EC1A 7BE",{"type":66,"coordinates":300},[301,302],-0.12574,51.50853,{"lat":302,"lon":301},[305],{"name":306,"role":52,"phone":307,"phoneExt":54,"email":308},"Kenrick Ng, MD","+44 (0)20 7377 700","kenrick.ng3@nhs.net",{"facility":310,"status":59,"city":311,"state":54,"zip":312,"country":269,"countryCode":270,"cosmosGeoPoint":313,"geoPoint":317,"contacts":318},"James Cook University Hospital","Middlesbrough","TS4 3BW",{"type":66,"coordinates":314},[315,316],-1.23483,54.57623,{"lat":316,"lon":315},[319],{"name":320,"role":52,"phone":321,"phoneExt":54,"email":322},"Darren Leaning, MD","+44 (0) 164285 0850","d.leaning@nhs.net",{"facility":324,"status":59,"city":325,"state":54,"zip":54,"country":269,"countryCode":270,"cosmosGeoPoint":326,"geoPoint":330,"contacts":331},"Oxford University Hospitals NHS Foundation Trust","Oxford",{"type":66,"coordinates":327},[328,329],-1.25596,51.75222,{"lat":329,"lon":328},[332],{"name":333,"role":52,"phone":334,"phoneExt":54,"email":335},"Philip Camilleri","+44 (0)1865 572033","philip.camilleri@ouh.nhs.uk",{"facility":337,"status":59,"city":338,"state":54,"zip":54,"country":269,"countryCode":270,"cosmosGeoPoint":339,"geoPoint":343,"contacts":344},"Weston Park","Sheffield",{"type":66,"coordinates":340},[341,342],-1.4659,53.38297,{"lat":342,"lon":341},[345],{"name":346,"role":52,"phone":347,"phoneExt":54,"email":348},"Omar Din","+44 (0) 114226 5068","o.din@nhs.net",{"facility":350,"status":59,"city":351,"state":54,"zip":352,"country":269,"countryCode":270,"cosmosGeoPoint":353,"geoPoint":357,"contacts":358},"University Hospital Southampton NHS Foundation Trust","Southampton","SO16 6YD",{"type":66,"coordinates":354},[355,356],-1.40428,50.90395,{"lat":356,"lon":355},[359],{"name":360,"role":52,"phone":361,"phoneExt":54,"email":362},"Simon Crabb, MD","+44 (0) 2381 205 170","s.j.crabb@southampton.ac.uk",{"type":364,"investigatorFullName":54,"investigatorTitle":54,"investigatorAffiliation":54,"oldNameTitle":54,"oldOrganization":54},"SPONSOR",[366],{"name":367,"class":6},"PSI CRO","100471052","phase-1-anti-tumour-activity-of-177lu-rhpsma-101-injection-100471052",false,"NCT05413850","Anti-tumour Activity of (177Lu) rhPSMA-10.1 Injection","An Open-label, Multicentre, Integrated Phase 1 & 2 Study to Evaluate the Safety, Tolerability, Radiation Dosimetry and Anti-tumour Activity of Lutetium (177Lu) rhPSMA-10.1 Injection in Men With Metastatic Castrate-resistant Prostate Cancer","Inclusion Criteria:\n\n1. Male subjects, 18 years of age or older with histologically confirmed adenocarcinoma of the prostate.\n2. Serum testosterone levels \\\u003C50 ng\u002FdL (1.73 nmol\u002FL) after surgical or continued chemical castration.\n3. Presence of disease target or non target lesions (per RECIST v1.1) on CT\u002FMRI and\u002For presence of disease on full body 99mTc bone scan performed within 28 days of screening.\n4. Positive disease expression of PSMA as confirmed on PSMA PET\u002FCT scan.\n5. At least 4 weeks or 5 half-lives (whichever is longer) elapsed between last anti-cancer treatment administration and the initiation of study treatment (except for Luteinising Hormone-releasing Hormone or GnRH).\n6. Resolution of all previous treatment related toxicities to CTCAE version 5.0 grade of ≤1 (except for chemotherapy induced alopecia and grade 2 peripheral neuropathy or grade 2 urinary frequency which are allowed).\n7. Prior major surgery must be at least 12 weeks prior to study entry.\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 with a life expectancy ≥6 months.\n9. Adequate bone marrow reserve and organ function as demonstrated by blood count, and serum biochemistry at baseline.\n10. Adequate contraception for patients and their partners.\n11. For Phase 1 mCRPC only: Subjects who have experienced disease progression on or after at least 1 NAAD (e.g. abiraterone, enzalutamide) and at least 1 course (but no more than 2 courses) of taxane-based chemotherapy. For Phase 2 mCRPC only: Subjects who have experienced disease progression on or after at least 1 NAAD (e.g. abiraterone, enzalutamide, apalutamide, darolutamide), but have not received previous taxane-based chemotherapy for the treatment of mCRPC.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to the therapeutic or diagnostic IMP or any of its constituents.\n2. Presence of significant PSMA-negative disease on ceCT\u002FMRI scan\n3. Diffuse marrow infiltration of disease ('superscan' appearance on full body 99mTc bone scan).\n4. Symptomatic spinal cord compression, or clinical or radiological findings that are indicative of impending spinal cord compression.\n5. Known history of haematological malignancy.\n6. Known history of central nervous system (CNS) metastases.\n7. Histological findings consistent with neuroendocrine phenotype of prostate cancer.\n8. Known history of other solid malignancy that may reduce life expectancy and\u002For may interfere with disease assessment.\n9. Unresolved urinary tract obstruction defined as radiographic evidence of hydronephrosis with or without ureteric stent\u002Fnephrostomy.\n10. Any uncontrolled significant medical, psychiatric, or surgical condition or laboratory finding that would pose a risk to subject safety or interfere with study participation or interpretation of individual subject results.\n11. Ongoing treatment with bisphosphonates for bone-targeted therapy.\n12. Severe urinary incontinence that would preclude safe disposal of radioactive urine.\n13. Single kidney or renal transplant or any concomitant nephrotoxic therapy that might put the subject at high risk of renal toxicity during the study in the judgement of the investigator.\n14. Clinically significant abnormalities on a single 12 lead electrocardiogram (ECG) at screening.\n15. Previously received external beam irradiation to a field that includes more than 30% of the bone marrow or kidneys.\n16. Previous treatment with any of the following: PSMA targeted radionuclide therapy, Strontium-89, Samarium-153, Rhenium 186, Rhenium-188, Radium-223, hemi-body irradiation.\n17. Subjects with bilateral hip replacements or any significant metallic implants or objects, that may affect image quality and\u002For dosimetry calculations.\n18. Transfusion of blood products for the sole purpose of meeting the eligibility criteria for this clinical study.\n19. Participation in other studies involving IMP(s) within 28 days or 5 half-lives (whichever is longer) prior to study entry and\u002For during study participation.\n20. Any history of clinically significant parenchymal lung disease e.g. interstitial lung disease or bullous emphysema.\n21. Any history of prior thoracic external beam radiotherapy.\n22. Presence of abnormal PSMA PET uptake in the lung parenchyma above expected physiological levels, as determined by local assessment.","MALE","18 Years",{"count":378,"type":379},82,"ESTIMATED","INTERVENTIONAL",[382,383],"PHASE1","PHASE2","To determine the dose, safety, radiation dosimetry and efficacy of 177Lu-rhPSMA-10.1 in participants with PSMA-expressing metastatic castrate resistant prostate cancer.",[386,387,388,389,390,391],"Prostate Cancer","Metastatic Castration-resistant Prostate Cancer","mCRPC","Urogenital Neoplasms","Prostatic Neoplasms","Prostatic Diseases",[393,388,394,395,396,397,398,399,400],"PSMA","Prostate cancer","177Lu rhPSMA-10.1","18F-rhPSMA-7.3","BET-PSMA-121","Blue Earth Therapeutics Limited","Radiohybrid","Radiopharmaceuticals","2026-05-12",{"date":403,"type":404},"2026-05-14","ACTUAL",{"date":406,"type":404},"2022-07-20",{"date":408,"type":379},"2028-03-31",{"name":5,"class":6},21]