[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100505960":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":30,"centralContacts":31,"locations":35,"responsibleParty":109,"collaborators":111,"id":114,"slug":115,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":30,"eligibilityCriteria":120,"healthyVolunteers":116,"sex":121,"minAge":122,"maxAge":30,"enrollmentInfo":123,"targetDuration":30,"studyType":126,"phases":127,"briefSummary":129,"conditions":130,"keywords":134,"overallStatus":38,"whyStopped":30,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"Telix Pharmaceuticals (Innovations) Pty Limited","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"89Zr-TLX250, 177Lu-TLX250 and Peposertib","EXPERIMENTAL","Diagnostic test: A single IV administration of 37 Megabecquerel (+\u002F- 10%) 89Zr-DFO-girentuximab, containing a mass dose of 10 mg of girentuximab, followed by a diagnostic scan\n\nTreatment test: A single IV administration that could be 1887 - 2516 or 3145 Megabecquerel (+\u002F- 10%) 177Lu-DOTA-girentuximab,containing a mass dose of 10 mg of girentuximab, on Day 1 of each 84-day cycle and p.o. administration of that could be 100-150 or 200 mg Peposertib BID on days 4-21 of each 84-day cycle.",[13,14],"Diagnostic Test: 89Zr-TLX250","Combination Product: 177Lu-TLX250 and Peposertib",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DIAGNOSTIC_TEST","89Zr-TLX250","Single IV administration followed by 89Zr-DFO-girentuximab PET\u002FCT (or PET\u002FMRI) scan at screening and approximately 8-10 weeks (±1 week) after Cycle 3 Day 1, as well as at the end of treatment visit (if feasible). The PET\u002FCT should be obtained within 4-7 days after 89Zr-TLX250 administration",[9],[22],"89Zr-DFO-girentuximab",{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"COMBINATION_PRODUCT","177Lu-TLX250 and Peposertib","Dose escalation and de-escalation for the determination of the Maximum tolerated combination\u002F Recommended phase 2 dose.\n\nAll subjects will receive 177Lu-TLX250 intravenously on day 1 and Peposertib BID on days 4-21 of each 84-day cycle.",[9],[29],"177Lu-DOTA-girentuximab",null,[32],{"name":33,"role":34,"phone":30,"phoneExt":30,"email":30},"MEDICAL DIRECTOR, MD","CONTACT",[36,57,70,83,96],{"facility":37,"status":38,"city":39,"state":40,"zip":30,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Macquarie University","RECRUITING","North Ryde","New South Wales","Australia","AU",{"type":44,"coordinates":45},"Point",[46,47],151.12436,-33.79677,{"lat":47,"lon":46},[50,54],{"name":51,"role":34,"phone":52,"phoneExt":30,"email":53},"Principal Investigator","0000000","info@telixpharma.com",{"name":55,"role":56,"phone":30,"phoneExt":30,"email":30},"Howard Gurney","PRINCIPAL_INVESTIGATOR",{"facility":58,"status":38,"city":59,"state":30,"zip":30,"country":41,"countryCode":42,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Ashford (Icon) Cancer Centre","Adelaide",{"type":44,"coordinates":61},[62,63],138.59863,-34.92866,{"lat":63,"lon":62},[66,68],{"name":51,"role":34,"phone":67,"phoneExt":30,"email":53},"00",{"name":69,"role":56,"phone":30,"phoneExt":30,"email":30},"Dainik Patel",{"facility":71,"status":38,"city":72,"state":30,"zip":30,"country":41,"countryCode":42,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Princess Alexandra Hospital","Brisbane",{"type":44,"coordinates":74},[75,76],153.02809,-27.46794,{"lat":76,"lon":75},[79,81],{"name":51,"role":34,"phone":80,"phoneExt":30,"email":53},"00000000",{"name":82,"role":56,"phone":30,"phoneExt":30,"email":30},"Kenneth O'Byrne",{"facility":84,"status":38,"city":85,"state":30,"zip":30,"country":41,"countryCode":42,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Austin Health","Melbourne",{"type":44,"coordinates":87},[88,89],144.96332,-37.814,{"lat":89,"lon":88},[92,94],{"name":93,"role":34,"phone":80,"phoneExt":30,"email":53},"Princiapl Investigator",{"name":95,"role":56,"phone":30,"phoneExt":30,"email":30},"Andrew Scott",{"facility":97,"status":38,"city":98,"state":30,"zip":30,"country":41,"countryCode":42,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"GenesisCare Murdoch","Perth",{"type":44,"coordinates":100},[101,102],115.8614,-31.95224,{"lat":102,"lon":101},[105,107],{"name":51,"role":34,"phone":106,"phoneExt":30,"email":53},"0000",{"name":108,"role":56,"phone":30,"phoneExt":30,"email":30},"Nat Lenzo",{"type":110,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[112],{"name":113,"class":6},"Merck KGaA, Darmstadt, Germany","100505960","phase-1-combination-of-177lu-tlx250-and-peposertib-in-patients-with-carbonic-anhydrase-ix--expressing-solid-tumors-100505960",false,"NCT05868174","Combination of 177Lu-TLX250 and Peposertib in Patients With Carbonic Anhydrase IX -Expressing Solid Tumors","A Phase 1b Dose Escalation\u002FExpansion Study of the Combination of 177Lu-TLX250 and Peposertib in Patients With Carbonic Anhydrase IX (CAIX)-Expressing Solid Tumors","Inclusion Criteria:\n\n* Histologically confirmed advanced or metastatic solid tumor that has progressed on or during\u002Fafter recognized standard of care therapies and are not eligible for resection, or patients that are not eligible or not consenting to recognized standard of care therapies.\n* At least one measurable lesion on CT\u002FMRI according to RECIST 1.1 with corresponding 89Zr-TLX250 uptake (i.e., CAIX positive).\n* CAIX positivity in at least 75% of the total lesion volume (defined as 89Zr- TLX250 uptake with intensity significantly greater than normal liver \\[i.e., standardized uptake value \\[SUV\\]max at least 1.5 times SUV of normal liver\\]).\n* ECOG status 0 or 1.\n* Have adequate organ function during screening\n* Must have a life expectancy of at least 6 months.\n\nExclusion Criteria:\n\n* Prior 177Lu-TLX250 or other radioligand therapy; or any prior CAIX targeting therapy.\n* Known hypersensitivity to compounds of similar chemical or biologic composition to peposertib, girentuximab radiolabelled by zirconium or lutetium, any excipient in the study medication or any other intravenously administered human proteins\u002Fpeptides\u002Fantibodies.\n* Administration of any radionuclide within 10 half-lives of the radionuclide prior to signature of the ICF.\n* Patients who have had chemotherapy, definitive radiation, biological cancer therapy, or investigational agent\u002Fdevice within 28 days of first planned dose of study therapy.\n* Patients who had \\> 2 prior lines of cytotoxic chemotherapy or had Grade 4 neutropenia or Grade 3\u002FGrade 4 thrombocytopenia (both of a duration of at least 48 hours) during the last line of therapy. Note: This criterion may be removed in total or in part by the SRC upon review of the safety data from the initial dose level(s).\n* Patients who cannot discontinue concomitant medications or herbal supplements that are strong inhibitors or strong inducers of cytochrome P450 (CYP) isoenzymes CYP3A4\u002F5, CYP2C9, and CYP2C19. Concomitant use of CYP3A4\u002F5 substrates with a narrow therapeutic index are also excluded.\n* Patients who cannot discontinue concomitant H2-blockers or proton-pump inhibitors (PPIs). Patients may confer with the investigator to determine if such medications can be discontinued. These must be discontinued ≥ 5 days prior to study treatment. Patients do not need to discontinue calcium carbonate.\n* Patients who are receiving therapeutic doses of anticoagulation, including but not limited to low-molecular weight heparin in therapeutic dosing or platelet aggregation inhibitors. Note: This criterion may be removed by the SRC upon review of the safety data from the initial dose level(s).\n* Patients with ≥ 5 bone metastases and\u002For bulky (\\> 3cm in diameter) pelvic or femoral tumors, and\u002For metastases\u002Ftumor in the vertebral spine involving \\> 3 vertebrae.\n* Any severe concomitant condition which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol, in the opinion of the investigator.\n* Presence of active and uncontrolled infections or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study.\n* Requirement of concurrent use of other anti-cancer treatments or agents other than study medications. Supportive care therapies are permitted.","ALL","18 Years",{"count":124,"type":125},36,"ESTIMATED","INTERVENTIONAL",[128],"PHASE1","This is an open label, single-arm, multicentre dose escalation (Part 1) and dose expansion (Part 2) study to evaluate different combinations of 3 radioactive dose levels of 177Lu-TLX250 administered intravenously with 3 different doses of peposertib in patients with CAIX-expressing solid tumors.",[131,132,133],"Solid Tumor, Adult","Advanced Solid Tumor","Advanced Renal Cell Carcinoma",[135],"CAIX","2024-04-29",{"date":138,"type":139},"2024-05-01","ACTUAL",{"date":141,"type":139},"2023-05-23",{"date":143,"type":125},"2026-12",{"name":5,"class":6},5]