Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2025-12-29 @ 12:53 AM
Study NCT ID:
NCT05773703
Status:
COMPLETED
Last Update Posted:
2023-12-13
First Post:
2023-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploratory PK and Imaging Study of PSMA-Targeted Trillium Compounds and PTI-122 in Metastatic Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Each Trillium Compound will first be evaluated alone, then with single doses (5, 10, 15 mg) of the cytoprotective agent, PTI-122. Trillium Compound with two doses of PTI-122 at the preferred dose level may be studied if indicated.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-12', 'studyFirstSubmitDate': '2023-02-23', 'studyFirstSubmitQcDate': '2023-03-15', 'lastUpdatePostDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount of radiotracer absorbed by tumor', 'timeFrame': 'Over 168 hours post-injection', 'description': 'Tumor uptake measured on imaging'}, {'measure': 'Amount of radioactivity in blood', 'timeFrame': 'Over 168 hours post-injection', 'description': 'Radioactivity measured pre- and post-radiotracer injection'}, {'measure': 'Amount of radiotracer absorbed by organs', 'timeFrame': 'Over 168 hours post-injection', 'description': 'Organ uptake measured on imaging'}], 'secondaryOutcomes': [{'measure': 'Amount of PTI-122 in blood', 'timeFrame': 'Over 168 hours post-injection', 'description': 'PTI-122 measured pre- and post-dose'}, {'measure': 'Incidence of adverse events', 'timeFrame': 'Over 168 hours post-injection', 'description': 'Occurrence of adverse events during the study'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'Exploratory study in adult males with metastatic prostate cancer intended to characterize the pharmacokinetics and biodistribution of PSMA-Targeted \\[In-111\\]-Labeled Trillium Compounds with and without the cytoprotective agent PTI-122. Up to 36 eligible subjects will be enrolled. Additional subjects may be enrolled if there is insufficient data for evaluation, for example if the original study subjects do not complete required imaging studies for reasons unrelated to adverse events.\n\nUp to four PSMA-Targeted \\[In-111\\]-Labeled Trillium Compounds will be evaluated. Each compound will be evaluated first without the cytoprotective agent, PTI-122, then the \\[In-111\\]-labeled Trillium Compound may be co-administered with PTI-122.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Males with prostate cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult males with metastatic prostate cancer\n* ECOG performance score 0-2\n* Stable androgen deprivation or other hormone therapy (30 days) or therapy planned but not yet initiated\n* PSMA PET scan between 3 and 28 days prior to radiotracer injection with at least 2 PSMA positive lesions and either:\n\n 1. One soft tissue lesion measuring ≥ 15 mm in the longest diameter with SUVmax lesion ≥ SUVmean normal liver, OR\n 2. Two bone lesions measuring ≥ 15 mm in the longest diameter with SUVmax lesion ≥ 2 x SUVmax normal liver\n* Able to understand and adhere to study requirements, and voluntarily give informed consent\n\nExclusion Criteria:\n\n* No other malignancy undergoing treatment\n* No PSMA-targeted therapy ongoing\n* Inability or unwillingness to undergo SPECT/CT imaging\n* Serum creatinine \\> 1.5 mg/dL or creatinine clearance ≤50 mL/min by Cockcroft-Gault estimation\n* Concurrent participation in the active treatment phase of another clinical trial of investigational medicinal product(s)\n* Significant intercurrent illness, treatment-related toxicity, or psychiatric illness/social situation that could place the subject at undue risk during study participation, significantly alter study outcomes, or affect subject compliance with study requirements for dosing and evaluation, as determined by the investigator'}, 'identificationModule': {'nctId': 'NCT05773703', 'briefTitle': 'Exploratory PK and Imaging Study of PSMA-Targeted Trillium Compounds and PTI-122 in Metastatic Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ratio Therapeutics, Inc.'}, 'officialTitle': 'A Phase 0 Study of the Pharmacokinetics and Biodistribution of PSMA-Targeted [In-111]-Labeled Trillium Compounds With and Without PTI-122 in Patients With Metastatic Prostate Cancer to Inform Future Phase 1 Dosing With [Ac-225]-Trillium-PSMA Radionuclide Therapy', 'orgStudyIdInfo': {'id': 'RTX-PSMA-P101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trillium Compound Alone', 'description': 'Single dose of PSMA-Targeted \\[In-111\\]-Labeled Trillium Compound', 'interventionNames': ['Drug: PSMA-Targeted [In-111]-Labeled Trillium Compound']}, {'type': 'EXPERIMENTAL', 'label': 'Trillium Compound + Single Dose PTI-122', 'description': 'Single dose of PSMA-Targeted \\[In-111\\]-Labeled Trillium Compound plus single dose of PTI-122 at 5, 10 or 15 mg', 'interventionNames': ['Drug: PSMA-Targeted [In-111]-Labeled Trillium Compound', 'Drug: PTI-122']}, {'type': 'EXPERIMENTAL', 'label': 'Trillium Compound + Multiple Dose PTI-122', 'description': 'Single dose of PSMA-Targeted \\[In-111\\]-Labeled Trillium Compound plus two doses of PTI-122 at the preferred dose level', 'interventionNames': ['Drug: PSMA-Targeted [In-111]-Labeled Trillium Compound', 'Drug: PTI-122']}], 'interventions': [{'name': 'PSMA-Targeted [In-111]-Labeled Trillium Compound', 'type': 'DRUG', 'description': 'Radiotracer', 'armGroupLabels': ['Trillium Compound + Multiple Dose PTI-122', 'Trillium Compound + Single Dose PTI-122', 'Trillium Compound Alone']}, {'name': 'PTI-122', 'type': 'DRUG', 'description': 'Cytoprotective agent', 'armGroupLabels': ['Trillium Compound + Multiple Dose PTI-122', 'Trillium Compound + Single Dose PTI-122']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33165', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Biogenix Molecular', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '21061', 'city': 'Glen Burnie', 'state': 'Maryland', 'country': 'United States', 'facility': 'Advanced Molecular Imaging & Therapy', 'geoPoint': {'lat': 39.16261, 'lon': -76.62469}}, {'zip': '68130', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'XCancer Omaha/Urology Cancer Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '37920', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'University of Tennessee Medical Center', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}], 'overallOfficials': [{'name': 'John Babich, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ratio Therapeutics, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ratio Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}