Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-25 @ 9:15 PM
Study NCT ID:
NCT06710756
Status:
RECRUITING
Last Update Posted:
2025-10-16
First Post:
2024-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lead-212 PSV359 Therapy for Patients With Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D008654', 'term': 'Mesothelioma'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D018301', 'term': 'Neoplasms, Mesothelial'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 112}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-28', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2032-05-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-14', 'studyFirstSubmitDate': '2024-11-25', 'studyFirstSubmitQcDate': '2024-11-26', 'lastUpdatePostDateStruct': {'date': '2025-10-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determination of safety and tolerability of [203Pb]Pb-PSV359', 'timeFrame': '30 days (±1day) post dose', 'description': 'Incidence and severity of treatment-related adverse events following a single administration of \\[203Pb\\]Pb-PSV359 is determined'}, {'measure': 'Determination of safety and tolerability of [212Pb]Pb-PSV359', 'timeFrame': 'Up to 3 years', 'description': 'Incidence and severity of treatment-related adverse events following a single and each repeated administration of \\[212Pb\\]Pb-PSV359 is determined'}, {'measure': 'To determine the recommended phase 2 dose of [212Pb]Pb-PSV359', 'timeFrame': 'Up to approximately 6 months', 'description': 'The recommended phase 2 dose as determined by cohort observations and review by the Safety Monitoring Committee'}], 'secondaryOutcomes': [{'measure': 'Determination of duration of response following treatment with [212Pb]Pb-PSV359', 'timeFrame': 'Up to 3 years', 'description': 'Median duration of response for subjects receiving at least 1 administration of \\[212Pb\\]Pb-PSV359 is assessed by RECIST V1.1 criteria'}, {'measure': 'Determination of progression free survival following treatment with [212Pb]Pb-PSV359', 'timeFrame': 'Up to 3 years', 'description': 'Progression free survival for subjects receiving at least 1 administration of \\[212Pb\\]Pb-PSV359 is assessed by RECIST V1.1 criteria'}, {'measure': 'Determination of pharmacokinetic properties of [203Pb]Pb-PSV359 and [212Pb]Pb-PSV359', 'timeFrame': 'Up to approximately 3 yrs', 'description': 'Blood radioactivity pharmacokinetic parameter such as area under the plasma concentration versus time curve (AUC) is determined.'}, {'measure': 'Determination of pharmacokinetic properties of [203Pb]Pb-PSV359 and [212Pb]Pb-PSV359', 'timeFrame': 'up to approximately 3 years', 'description': 'Blood radioactivity pharmacokinetic parameter such as peak plasm concentration (Cmax) is determined'}, {'measure': 'Determination of pharmacokinetic properties of [203Pb]Pb-PSV359 and [212Pb]Pb-PSV359', 'timeFrame': 'up to approximately 3 years', 'description': 'Blood radioactivity pharmacokinetic parameter such as the time (Tmax) to reach the maximum concentration (Cmax) is determined'}, {'measure': 'Estimation of biodistribution of 203Pb PSV 359 using SPECT/CT scans', 'timeFrame': 'Up to approximately 3 years', 'description': 'Activity in tumor(s) and organs as percentage of injected dose is assessed'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fibroblast Activation Protein', 'Solid tumor malignancy', 'Gastric cancer', 'Esophageal cancer', 'Colorectal cancer', 'Ovarian cancer', 'Head and neck cancer', 'Theronostic', 'Radiopharmaceutical', 'Radiotherapy', 'Alpha Particle', 'Pb-203', 'Pb-212'], 'conditions': ['Pancreatic Ductal Adenocarcinoma', 'Gastric Cancer', 'Esophageal Cancer', 'Colorectal Cancer', 'Ovarian Cancer', 'Head and Neck Cancer', 'Sarcoma', 'Mesothelioma']}, 'descriptionModule': {'briefSummary': 'Phase I/IIa 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.', 'detailedDescription': 'This is a prospective, multi-center open label dose finding, dose expansion study of \\[212Pb\\]Pb-PSV359 in subjects with a positive Fibroblast Activation Protein (FAP) imaging scan with imaging agent.\n\nFAP is specifically expressed on the surface of cancer-associated fibroblasts in some tumor tissues and therefore is an attractive target in the diagnosis and treatment of various cancers. Lead-212 (\\[212Pb\\]Pb-) based peptide-radiopharmaceuticals are an emerging class of targeted alpha-particle cancer therapies that have potential to improve delivery of a highly effective form of radiation.\n\nThis study will be conducted in 2 parts:\n\nPart 1: Dose-escalation: \\[212Pb\\]Pb-PSV359 is administered in escalating doses to determine the Maximum Tolerated radioactivity (MTD) Dose and potential recommended Phase 2 dose (RP2D).\n\nPart 2: Dose-expansion: This part will enroll subjects in expansion cohorts based on the identified MTD and RP2D for the selection of \\[212Pb\\]Pb-PSV359 doses for further clinical development.\n\nA Dosimetry sub-set utilizing an imaging surrogate, \\[203Pb\\]Pb-PSV359, has been incorporated into the study in order to assess organ biodistribution and tumor uptake of the investigational products. This sub study will also estimate radiation dosimetry and correlate uptake of the investigation products with observed toxicities and efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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/CT scan showing uptake of \\[203Pb\\]Pb-PSV359 in at least 1 known lesion on the 1-hour SPECT/ CT scan\n* Histological, pathological, and/or 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/attenuated vaccine in the 7 days prior to enrollment\n* Previous treatment with any systemic anticancer therapy within 4 weeks prior to treatment on study'}, 'identificationModule': {'nctId': 'NCT06710756', 'briefTitle': 'Lead-212 PSV359 Therapy for Patients With Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Perspective Therapeutics'}, 'officialTitle': 'A Phase I/IIa 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', 'orgStudyIdInfo': {'id': 'PSV359-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Escalation', 'description': '* Enrolled subjects are administered \\[203Pb\\]Pb-PSV359 (7mCi) for imaging FAP-expressing cancers.\n* Approximately Four cohorts of \\[212Pb\\]Pb-PSV359 dose levels will be explored for determining Recommended Phase 2 Dose (RP2D). Study subjects will be assigned to cohorts sequentially.', 'interventionNames': ['Drug: [203Pb]Pb-PSV359', 'Drug: [212Pb]Pb-PSV359']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Expansion', 'description': '* Enrolled subjects are administered \\[203Pb\\]Pb-PSV359 (7mCi) for imaging FAP-expressing cancers.\n* Enrolled subjects are administered \\[212Pb\\]Pb-PSV359 (RP2D determined previously) for treatment of FAP-expressing cancers', 'interventionNames': ['Drug: [203Pb]Pb-PSV359', 'Drug: [212Pb]Pb-PSV359']}], 'interventions': [{'name': '[203Pb]Pb-PSV359', 'type': 'DRUG', 'description': '\\[203Pb\\]Pb-PSV359 is administered by intravenous bolus injection for single-photon emission computed tomography imaging.', 'armGroupLabels': ['Dose Escalation', 'Dose Expansion']}, {'name': '[212Pb]Pb-PSV359', 'type': 'DRUG', 'description': '\\[212Pb\\]Pb-PSV359 is administered by intravenous infusion for treatment of FAP expressing cancers.', 'armGroupLabels': ['Dose Escalation', 'Dose Expansion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anna Scannell', 'role': 'CONTACT', 'email': 'anna.scannell@health.slu.edu'}, {'name': 'Medhat Osman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Saint Louis University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68130', 'city': 'Omaha', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Hanna Kurz', 'role': 'CONTACT', 'email': 'hkurz@nebraskacancer.com', 'phone': '402-691-6974'}, {'name': 'Samuel Mehr, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nebraska Cancer Specialists', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'centralContacts': [{'name': 'ClinicalTrials at Perspectivetherapeutics', 'role': 'CONTACT', 'email': 'clinicaltrials@perspectivetherapeutics.com', 'phone': '(206) 676-0900'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Perspective Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}