[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Perspective Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":131},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,57,95],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100489606","phase-1-mc1r-targeted-alpha-particle-monotherapy-and-combination-therapy-trial-with-nivolumab-in-adults-with-advanced-melanoma-100489606",false,"NCT05655312","MC1R-targeted Alpha-particle Monotherapy and Combination Therapy Trial With Nivolumab in Adults With Advanced Melanoma","A Phase I\u002FIIa, First-In-Human, Multi-Center, Monotherapy and Combination-Therapy With Nivolumab, Dose-Finding and Dose-Expansion Study of [212Pb]VMT01 Melanocortin-1 Receptor-Targeted, Image-Guided Alpha-Particle Therapy in Subjects With Previously Treated Unresectable or Metastatic Melanoma","Inclusion Criteria:\n\n* Ability to understand and willingness to provide informed consent, willingness to comply with all study procedures for the duration of the study\n* Aged ≥ 18 years\n* Diagnosed with unresectable Stage III or Stage IV metastatic or recurrent melanoma\n* Previously progressed (radiological progression) on at least one approved systemic therapy for advanced melanoma\n* Uptake of \\[68Ga\\]VMT02 or \\[203Pb\\]VMT01 by PET or SPECT imaging observed in at least one melanoma tumor site using quantitative imaging analysis compared to reference normal tissue\n* Subjects on prior intravenous therapy (e.g., chemotherapy or checkpoint inhibitors), or prior oral therapy (e.g.,proto-oncogene B-RAF or mitogen-activated extracellular signal-regulated kinase inhibitors) who demonstrate MC1R positivity during screening are eligible for enrollment, provided that they undergo a wash-out period of 21 days, or 7 days, respectively, prior to Cycle 1 Day 1 treatment with \\[212Pb\\]VMT01.\n* Presence of measurable disease by RECIST v1.1 assessed within 45 days prior to the first dose of \\[212Pb\\]VMT01 on Cycle 1 Day 1\n* Ability to lie flat and still for up to two hours for imaging scans; moderate conscious sedation allowed if indicated\n* For females of reproductive potential: agree to use of highly effective contraception and refrain from donating eggs (ova, oocytes) for the purpose of reproduction starting from screening, during treatment with \\[212Pb\\]VMT01 and\u002For nivolumab, and for at least 6 months after the last dose of \\[212Pb\\]VMT01 and\u002For nivolumab, whichever is administered last\n* For males of reproductive potential: agree to use of condoms or other methods to ensure effective contraception and refrain from donating sperm starting from screening, during treatment with \\[212Pb\\]VMT01 and\u002For nivolumab, and for at least 6 months after the last dose of \\[212Pb\\]VMT01 and\u002For nivolumab, whichever is administered last\n* Eastern Cooperative Oncology Group performance score of \\\u003C 2 at Screening\n* Life expectancy of at least 3 months after Cycle 1 Day 1\n* Satisfactory organ function determined by laboratory testing\n\nExclusion Criteria:\n\n* Active secondary malignancy\n* Prior systematic treatment with radioactive nuclides. Subjects who had localized treatment with radioactive nuclides or imaging using radioactive imaging agents may be enrolled\n* Pregnancy or breastfeeding a child\n* Any serious\u002Factive\u002Funcontrolled infection requiring parenteral antibiotics within 2 weeks before the first administration of \\[212Pb\\]VMT01\n* Febrile illness within 48 hours of any scheduled investigational product (\\[212Pb\\]VMT01, \\[203Pb\\]VMT01, or \\[68Ga\\]VMT02) administration; subjects should be rescheduled \\> 48 hours after resolution of fever\n* Treatment with another investigational drug product (therapeutic IND agents) within the last 45 days before the first dose of \\[212Pb\\]VMT01 on C1D1.\n* Current abuse of alcohol or illicit drugs\n* Existence of any medical or social issues likely to interfere with study conductor that may cause increased risk to the subject or to others, e.g., lack of ability to follow radiation safety precautions\n\nAdditional exclusion criteria for subjects who will receive combination therapy with nivolumab:\n\n* Untreated central nervous system (CNS) metastasis or metastasis requiring acute therapy of any modality. Subjects must have been either off corticosteroids, or on a stable or decreasing dose of prednisone (or equivalent) for at least 2 weeks prior to the first dose of \\[212Pb\\]VMT01\n* Subjects with an active, known, or suspected autoimmune disease\n* Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications\n* Acute or chronic hepatitis B (e.g., Hepatitis B surface antigen reactive), hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected) or known history of Human Immunodeficiency Virus (HIV) with an acquired immunodeficiency syndrome\n* Treatment with complementary medications (e.g., herbal supplements or traditional Chinese medicines)\n* Existence of abnormal laboratory values in hematology, liver, and renal function\n* Treatment with any live\u002Fattenuated vaccine within 30 days prior to the first dose of \\[212Pb\\]VMT01\n* Any treatment-related toxicities from prior systemic immune therapy with the exception of those unlikely to re-occur with standard countermeasures\n* History of allergy or hypersensitivity to nivolumab or its components","ALL","18 Years","90 Years",{"count":20,"type":21},300,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","In this first-in human, phase I\u002FIIa study, the safety and efficacy of \\[212Pb\\]VMT01, an alpha-particle emitting therapeutic agent targeted to melanocortin sub-type 1 receptor (MC1R) is being evaluated as a monotherapy and in combination with nivolumab in subjects with unresectable and metastatic melanoma.",[28,29,30,31],"Recurrent Melanoma (Skin)","Metastatic Melanoma","Melanoma Stage IV","Melanoma Stage III",[33,34,35,36,37,38,39,40,41,42,43],"Melanoma","Theranostic","Radiopharmaceutical","Radiotherapy","Alpha Particle","Melanocortin Receptor Sub-type 1 (MC1R)","VMT01-T101","Pb-203","Pb-212","Ga-68","Nivolumab","RECRUITING","2026-06-08",{"date":47,"type":48},"2026-06-10","ACTUAL",{"date":50,"type":48},"2023-06-01",{"date":52,"type":21},"2029-12-31",{"name":54,"class":55},"Perspective Therapeutics","INDUSTRY",13,{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":64,"targetDuration":4,"studyType":22,"phases":66,"briefSummary":67,"conditions":68,"keywords":77,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},"100570708","phase-1-lead-212-psv359-therapy-for-patients-with-solid-tumors-100570708","NCT06710756","Lead-212 PSV359 Therapy for Patients With Solid Tumors","A Phase I\u002FIIa Image-Guided, Alpha-Particle Therapy Study of [203Pb]Pb-PSV359 and [212Pb]Pb-PSV359 in Patients With Solid Tumors That Are Known to be Fibroblast Activation Protein (FAP)-Positive","Inclusion Criteria:\n\n* Aged ≥ 18 years\n* Satisfactory organ function as determined by laboratory testing\n* Eastern Cooperative Oncology Group performance (ECOG) status of 0 to 1\n* Life expectancy \\> 3 months\n* Progressive disease despite standard therapy or for whom no standard therapy exists\n* Positive \\[203Pb\\]Pb-PSV359 SPECT\u002FCT scan showing uptake of \\[203Pb\\]Pb-PSV359 in at least 1 known lesion on the 1-hour SPECT\u002F CT scan\n* Histological, pathological, and\u002For cytological confirmation of solid tumor malignancy that is locally advanced or metastatic\n\nExclusion Criteria:\n\n* Known hypersensitivity to the active agent or any of the excipients\n* Active secondary malignancy\n* Pregnancy or breastfeeding a child\n* Known brain metastases\n* Known active or uncontrolled infections requiring ongoing antifungals or antibiotics in the 3 days prior to enrollment\n* Known medical condition which would make this protocol unreasonably hazardous for the patient\n* Existence of any medical or social issues likely to interfere with study conductor that may cause increased risk to the subject or to others, e.g., lack of ability to follow radiation safety precautions\n* Medical history of a condition resulting in a severe allergic reaction such as anaphylaxis or angioedema to known components of the investigational product or excipients\n* Major surgery within 21 days prior to the administration of \\[212Pb\\]Pb-PSV359; the subject must be sufficiently recovered and stable before treatment administration\n* Diagnosis of deep vein thrombosis or pulmonary embolism within 4 weeks prior to enrollment into the study\n* Current abuse of alcohol or illicit drugs\n* Treatment with any live\u002Fattenuated vaccine in the 7 days prior to enrollment\n* Previous treatment with any systemic anticancer therapy within 4 weeks prior to treatment on study",{"count":65,"type":21},112,[24,25],"Phase I\u002FIIa image-guided, alpha-particle therapy study of \\[203Pb\\]Pb-PSV359 and \\[212Pb\\]Pb-PSV359 in patients with solid tumors that are known to be Fibroblast Activation Protein (FAP)-positive.",[69,70,71,72,73,74,75,76],"Pancreatic Ductal Adenocarcinoma","Gastric Cancer","Esophageal Cancer","Colorectal Cancer","Ovarian Cancer","Head and Neck Cancer","Sarcoma","Mesothelioma",[78,79,80,81,82,83,84,85,35,36,37,40,41],"Fibroblast Activation Protein","Solid tumor malignancy","Gastric cancer","Esophageal cancer","Colorectal cancer","Ovarian cancer","Head and neck cancer","Theronostic","2026-06-03",{"date":88,"type":48},"2026-06-05",{"date":90,"type":48},"2025-04-28",{"date":92,"type":21},"2032-05-28",{"name":54,"class":55},8,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":102,"targetDuration":4,"studyType":22,"phases":103,"briefSummary":104,"conditions":105,"keywords":113,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},"100488169","phase-1-targeted-alpha-particle-therapy-for-advanced-somatostatin-receptor-type-2-sstr2-positive-tumors-100488169","NCT05636618","Targeted Alpha-Particle Therapy for Advanced Somatostatin Receptor Type 2 (SSTR2) Positive Tumors","A Phase I\u002FIIa First-in-Human Study of [212Pb]VMT-α-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Tumors","Inclusion Criteria:\n\n1. Adult (ages ≥18) PRRT-naïve subjects with NETs or meningioma by local pathology.\n2. Disease described clinically as: (a) Locally advanced\u002Funresectable or metastatic NETs for dose-finding part of the study (b) Locally advanced\u002Funresectable or metastatic GEP-NETs, bronchial NETs, pheochromocytoma, or paragangliomas for the dose-expansion part of the study (c) Requiring at least 1 prior surgery (resection\u002Fbiopsy) and a maximum of 1 line of EBRT, if technically feasible, for meningioma.\n3. For meningioma: histologically confirmed diagnosis of meningioma, i.e., all grades (1 to 3) per World Health Organization Classification of Tumors of the Central Nervous System (5th edition; WHO-CNS5)\n4. Radiological evidence of measurable disease by: (a) For NETs: RECIST v1.1 criteria on CT with contrast or MRI of the areas of tumor involvement within 60 days of enrollment.\n5. Lesions must have shown radiological evidence of disease progression in the 12 months prior to enrollment. (b) For meningioma: RANO meningioma criteria on contrast-enhanced skull MRI for meningioma within 3 weeks prior to enrollment.\n6. Demonstration of lesional SSTR expression: (a) For NETs: using an FDA-approved somatostatin receptor PET imaging agent, e.g. \\[68Ga\\]DOTATATE, \\[64Cu\\]DOTATATE, or \\[68Ga\\]DOTATOC (b) For meningioma: using a standard-of-care SSTR PET imaging agent within 45 days of enrollment\n7. ECOG Performance Status ≤ 1.\n8. Subjects with HIV positivity are allowed if CD4 Count \\> 350 cells\u002FμL.\n9. Concurrent Somatostatin Analog (SSA) Therapy use while on protocol therapy is allowed provided that the subject must be able to tolerate withholding long-acting SSA therapy for a minimum of 28 days and short-acting SSA therapy for a minimum of 24 hours before the first and subsequent administrations of \\[203Pb\\]VMT-α-NET or \\[212Pb\\]VMT-α-NET\n10. For NETs: Progressive Disease on approved therapies other than radionuclide therapy.\n11. For subjects with meningioma who are receiving corticosteroid treatment, the dose must be ≤ 4 mg\u002Fday dexamethasone (or other corticosteroid equivalent dose) for a minimum of 7 days before the initiation of study treatment.\n12. Must have clinically demonstrated adequate catecholamine blockade if catecholamine-secreting pheochromocytoma\u002Fparaganglioma tumors are present.\n13. Able to understand and sign informed consent and comply with all study requirements.\n14. Life expectancy \\> 3 months.\n15. Satisfactory organ function as determined by laboratory testing.\n16. For females of reproductive potential: agree to use of highly effective contraception and refrain from donating eggs (ova, oocytes) for the purpose of reproduction starting from screening, during treatment, and for at least 6 months after the last dose of \\[212Pb\\]VMT-α-NET\n17. For males of reproductive potential: agree to use of condoms or other methods to ensure effective contraception with partner and refrain from donating sperm starting from screening, during treatment, and for at least 6 months after the last dose of \\[212Pb\\]VMT-α-NET\n\nExclusion Criteria:\n\n1. Known hypersensitivity to SSA, SSTR imaging agents or any of the excipients of \\[212Pb\\]VMT-α-NET.\n2. Known additional malignancy that is progressing or requires active treatment.\n3. Pregnancy or breastfeeding a child.\n4. Febrile illness within 48 hours of any scheduled \\[212Pb\\]VMT-α-NET administration should be rescheduled \\> 48 hours after resolution of fever\\].\n5. Treatment with another investigational medicinal product within 30 days of anticipated treatment.\n6. Prior treatment with systemic PRRT based therapies (i.e., \\[90Y\\] DOTATATE\u002FDOTATOC or \\[177Lu\\] DOTATATE)\n7. Prior treatment with 90-Yttrium radioembolization must be completed at least 6 months prior to enrollment.\n8. External beam radiation therapy (EBRT) must be completed at least 30 days prior to enrollment.\n9. Subjects who have received prior treatment with 90Y radioembolization or EBRT should have radiation absorbed dose to critical organs documented.\n10. Prior treatment with systemic anticancer therapy must be completed at least 30 days prior to enrollment (except for SSAs in subjects with functional tumors).\n11. Major surgery must be completed at least 30 days prior to enrollment.\n12. For Subjects with NETs: Known brain metastases; unless these metastases have been treated and stabilized 6 months prior to enrollment and the subject has been off steroid support for at least 14 days prior to enrollment.\n13. Recently diagnosed and active infections requiring a time-limited course of antifungals or antibiotics in the 3 days prior to enrollment.\n14. Receipt of live attenuated vaccines in the 7 days prior to enrollment.\n15. Grade 3 nausea\u002Fvomiting or diarrhea within 72 hours before the of first scheduled dose of \\[212Pb\\]VMT-α-NET despite adequate antiemetic and other supportive care\n16. Known medical condition which would make this protocol unreasonably hazardous for the subject.\n17. Medical history of a condition resulting in a severe allergic reaction such as anaphylaxis or angioedema to known components of the Investigational Medicinal Product or excipients.\n18. Current abuse of alcohol or illicit drugs (exclusive of use of medically prescribed cannabinoids).\n19. Existence of any medical or social issues likely to interfere with study conduct or that may cause increased risk to the subject or to others, e.g., lack of ability to follow radiation safety precautions.\n20. QTc \\> 450 milliseconds for males and females.",{"count":20,"type":21},[24,25],"This study is Phase I\u002FIIa First-in-Human Study of \\[212Pb\\]VMT-α-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Tumors",[106,107,108,109,110,111,112],"Neuroendocrine Tumors Unresectable","Neuroendocrine Tumor Metastatic","Gastroenteropancreatic Neuroendocrine Tumor","Bronchial Neuroendocrine Tumor","Paraganglioma","Pheochromocytoma","Meningioma",[114,115,116,117,41,118,119,36,120,121,40,112],"Radiopharmaceuticals","Somatostatin Receptor Type 2 (SSTR2)","Neuroendocrine Tumors","Metastatic Neuroendocrine Tumors","Theranostics","Alpha Particle Therapy","[212Pb]VMT-α-NET","VMT-α-NET-T01","2026-05-13",{"date":124,"type":48},"2026-05-14",{"date":126,"type":48},"2023-09-27",{"date":128,"type":21},"2029-12-26",{"name":54,"class":55},19,""]