[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100461030":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":25,"responsibleParty":130,"collaborators":19,"id":132,"slug":133,"hasResults":134,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":19,"eligibilityCriteria":138,"healthyVolunteers":134,"sex":139,"minAge":140,"maxAge":19,"enrollmentInfo":141,"targetDuration":19,"studyType":144,"phases":145,"briefSummary":147,"conditions":148,"keywords":156,"overallStatus":57,"whyStopped":19,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":183},{"fullName":5,"class":6},"Orano Med LLC","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"²¹²Pb-DOTAM-GRPR1","EXPERIMENTAL","In the dose escalation portion, a classic 3+3 design will be utilized for the SAD cohorts and a Boin design for the MAD cohorts. Doses will be increased by approximately 30% in subsequent cohorts. The maximum total dose that may be administered to a subject per cycle is 5.5 mCi +\u002F- 10%.",[13],"Drug: ²¹²Pb-DOTAM-GRPR1",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","²¹²Pb-DOTAM-GRPR1 is a radioimmunoconjugate comprised of ²¹²Pb, the metal chelator DOTAM (1,4,7,10-Tetrakis(carbamoylmethyl)-1,4,7,10- tetraazacyclododecane) and a GRPR-targeted antagonist.",[9],null,[21],{"name":5,"role":22,"phone":23,"phoneExt":19,"email":24},"CONTACT","469-638-0744","clinicaltrials@oranomed.com",[26,40,55,71,86,94,107,117],{"facility":27,"status":28,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":19},"Northwestern University Robert H Lurie Medical Research","ACTIVE_NOT_RECRUITING","Chicago","Illinois","60611","United States","US",{"type":35,"coordinates":36},"Point",[37,38],-87.65005,41.85003,{"lat":38,"lon":37},{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":32,"countryCode":33,"cosmosGeoPoint":46,"geoPoint":50,"contacts":51},"University of Iowa Health Care","NOT_YET_RECRUITING","Iowa City","Iowa","52242",{"type":35,"coordinates":47},[48,49],-91.53017,41.66113,{"lat":49,"lon":48},[52],{"name":53,"role":54,"phone":19,"phoneExt":19,"email":19},"David Bushness, MD","PRINCIPAL_INVESTIGATOR",{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":32,"countryCode":33,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"UK Markey Cancer Center","RECRUITING","Lexington","Kentucky","40536",{"type":35,"coordinates":62},[63,64],-84.47772,37.98869,{"lat":64,"lon":63},[67,69],{"name":19,"role":22,"phone":68,"phoneExt":19,"email":19},"859-323-7628",{"name":70,"role":54,"phone":19,"phoneExt":19,"email":19},"Eddy Yang, MD",{"facility":72,"status":57,"city":73,"state":74,"zip":75,"country":32,"countryCode":33,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Advanced Molecular Imaging and Therapy","Glen Burnie","Maryland","21061",{"type":35,"coordinates":77},[78,79],-76.62469,39.16261,{"lat":79,"lon":78},[82,84],{"name":19,"role":22,"phone":83,"phoneExt":19,"email":19},"443-333-1894",{"name":85,"role":54,"phone":19,"phoneExt":19,"email":19},"Michael Morris, MD",{"facility":87,"status":42,"city":73,"state":74,"zip":75,"country":32,"countryCode":33,"cosmosGeoPoint":88,"geoPoint":90,"contacts":91},"United Theranostics - Chesapeake",{"type":35,"coordinates":89},[78,79],{"lat":79,"lon":78},[92],{"name":93,"role":54,"phone":19,"phoneExt":19,"email":19},"Babak Saboury, MD",{"facility":95,"status":57,"city":96,"state":97,"zip":98,"country":32,"countryCode":33,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Nebraska Cancer Specialists (Midwest Cancer Center - Legacy)","Omaha","Nebraska","68130",{"type":35,"coordinates":100},[101,102],-95.94043,41.25626,{"lat":102,"lon":101},[105],{"name":106,"role":54,"phone":19,"phoneExt":19,"email":19},"Samuel Mehr, MD",{"facility":108,"status":57,"city":96,"state":97,"zip":98,"country":32,"countryCode":33,"cosmosGeoPoint":109,"geoPoint":111,"contacts":112},"XCancer Omaha \u002F Urology Cancer Center",{"type":35,"coordinates":110},[101,102],{"lat":102,"lon":101},[113,115],{"name":19,"role":22,"phone":114,"phoneExt":19,"email":19},"402-697-2229",{"name":116,"role":54,"phone":19,"phoneExt":19,"email":19},"Luke Nordquist, MD",{"facility":118,"status":42,"city":119,"state":120,"zip":121,"country":32,"countryCode":33,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"University of Pittsburg Medical Center (UPCM)","Pittsburgh","Pennsylvania","15219",{"type":35,"coordinates":123},[124,125],-79.99589,40.44062,{"lat":125,"lon":124},[128],{"name":129,"role":54,"phone":19,"phoneExt":19,"email":19},"Neeta Pandit Taskar, MD",{"type":131,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100461030","phase-1-safety-and-tolerability-of-pb-dotam-grpr1-in-adult-subjects-with-recurrent-or-metastatic-grpr-expressing-tumors-100461030",false,"NCT05283330","Safety and Tolerability of ²¹²Pb-DOTAM-GRPR1 in Adult Subjects With Recurrent or Metastatic GRPR-expressing Tumors","A Phase 1 Open-Label, First-in-human, Dose Escalation and Expansion Study to Determine the Safety, Tolerability, Dosimetry, Pharmacokinetics, and Preliminary Efficacy of 212Pb-DOTAM-GRPR1 in Adult Participants With Recurrent or Metastatic GRPR-expressing Tumors","1. Adult participants (age ≥ 18 years old) with any of the following advanced or metastatic solid tumors (documented history of histologically confirmed diagnosis):\n\n   1. Metastatic castration-resistant prostate cancer (mCRPC) including neuroendocrine prostate cancer (NEPC) (enrolled only in SAD and MAD Q6W)\n   2. HR+\u002FHER2- breast cancer (estrogen receptor\u002FER expression \\>10% of tumor cell nuclei stain, regardless of progesterone receptor\u002FPgR expression); HER2-negative including HER2-low (as per relevant ASCO\u002FCAP guidelines)\n   3. Colorectal cancer\n   4. Cervical cancer\n   5. Non-small-cell lung cancer (NSCLC)\n   6. Recurrent glioblastoma (only enrolled in MAD Q4W cohorts) with evidence of recurrent disease (RD) demonstrated by disease progression using modified Response Assessment in Neuro-Oncology (RANO 2.0) criteria. Note: If surgery is performed for GBM recurrence, pre-surgery MRI will be used for confirmation of RD and residual and measurable disease post-surgery is not required but surgery must have confirmed the recurrence diagnosis by MRI.\n2. Capable of giving signed informed consent\n3. All participants must have progressed on at least 2 prior systemic therapies, except for recurrent GB\n4. For participants with mCRPC: Prior orchiectomy and\u002For ongoing androgen deprivation therapy and a castrate level of serum testosterone (\\\u003C50 ng\u002FdL or \\\u003C1.7 nmol\u002FL)\n5. Presence of at least 1 measurable lesion per RECIST 1.1 as assessed by the Investigator (not applicable for GBM). At least 1 identified measurable lesion must show GRPR uptake in 203Pb-DOTAM-GRPR1 SPECT\u002FCT (uptake greater than that of the background) as assessed by the Investigator.\n6. For participants with prostate cancer that do not have measurable soft tissue disease, 203Pb-DOTAM-GRPR1 uptake in bone lesions \\> uptake in background is acceptable for eligibility.\n7. Eastern Cooperative Oncology Group (ECOG) status 0-1. Participants with ECOG status of 2 may be approved on a case-by-case basis in discussion with the Sponsor.\n8. Adequate bone marrow, hepatic, and renal function, as assessed by the following laboratory requirements:\n\n   1. White blood cell (WBC) ≥3000\u002F mm3 (≥ 3 x 109\u002FL)\n   2. Absolute neutrophil count (ANC) ≥1500\u002Fmm3 (≥1.5 x 109\u002FL)\n   3. Platelets ≥100,000\u002Fmm3 (≥ 100 x 109\u002FL)\n   4. Hemoglobin (Hb) ≥9.0 g\u002FdL\n   5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3x upper limit of normal (ULN) or ≤ 5 x ULN in the presence of liver metastases\n   6. Total bilirubin: ≤1.5 x ULN, except if documented history of Gilbert's disease who are eligible if total bilirubin ≤ 3 x ULN\n   7. Adequate renal function defined by creatinine clearance (CLCR) ≥ 60 mL\u002Fmin calculated as follows: CLCR = eGFR in ml\u002Fmin\u002F1.73 m2 calculated by the Modified Diet in Renal Disease (MDRD) x participant body surface area (BSA) in m2 ÷ 1.73\n   8. Serum amylase and\u002For lipase ≤1.5 x ULN\n9. For women of childbearing potential (WOCBP) and men with partners of childbearing potential: be willing to use highly effective methods of contraception or sexual abstinence, if part of participant's lifestyle, throughout the study and for 7 months for WOCBP, 4 months for men after the last \\[212Pb\\]Pb-DOTAM-GRPR1 administration or for 10 days following \\[203Pb\\]Pb-DOTAM-GRPR1 administration and participant is not proceeding to 212Pb-DOTAM-GRPR1 treatment, as outlined in protocol.\n\n   Participants with Recurrent Glioblastoma:\n10. Having first or second glioblastoma recurrence, after standard therapy that includes prior radiation therapy (RT) and at least 12 weeks from completion of RT prior to first administration of 212Pb-DOTAM-GRPR1. In case surgery has been performed for GBM recurrence, the surgery has to be completed at least 4 weeks prior to 212Pb-DOTAM-GRPR1 treatment start, with post-surgery recovery without any complications related to surgical procedure.\n11. Presence of 203Pb-DOTAM-GRPR1 uptake by SPECT\u002FCT scan in the tumor lesion(s).\n12. Presence of Gadolinium enhancement in the MRI in the tumor lesion(s) shown at the time of diagnosis of tumor recurrence.","ALL","18 Years",{"count":142,"type":143},48,"ESTIMATED","INTERVENTIONAL",[146],"PHASE1","A Phase 1 Open-Label, First-in-human, Dose Escalation and Expansion Study to Determine the Safety, Tolerability, Dosimetry, Pharmacokinetics, and Preliminary Efficacy of 212Pb-DOTAM-GRPR1 in Adult Participants with Recurrent or Metastatic GRPR-expressing Tumors",[149,150,151,152,153,154,155],"Cervical Cancer","Breast Cancer","Colon Cancer","NSCLC","mCRPC (Metastatic Castration-resistant Prostate Cancer)","Glioblastoma","Nonsmall Cell Lung Cancer",[157,158,159,160,161,162,163,164,149,165,166,167,168,169,170,171,172],"Metastatic Cancer","Advanced Cancer","Recurrent Cancer","Prostate Cancer, Castration-Resistant","Metastatic Prostate Cancer","Breast Cancer, Hormone Receptor Positive","Non-Small Cell Lung Cancer","Colorectal Cancer","Glioblastoma, Recurrent","Radioligand Therapy","Targeted Radiation Therapy","Gastrin-Releasing Peptide Receptor or Bombesin receptor subtype-2","Targeted Alpha Therapy","Lead-212 Radiopharmaceutical Therapy","Lead-203 Radiopharmaceutical Diagnostic","SPECT\u002FCT","2026-06-09",{"date":175,"type":176},"2026-06-11","ACTUAL",{"date":178,"type":176},"2022-12-22",{"date":180,"type":143},"2032-05",{"name":182,"class":6},"Orano Med Theranostics, SAS",8]