Ignite Creation Date:
2025-12-26 @ 4:03 PM
Ignite Modification Date:
2025-12-30 @ 4:05 PM
Study NCT ID:
NCT06450106
Status:
RECRUITING
Last Update Posted:
2025-06-27
First Post:
2024-06-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of STM-416p Administered to Patients Undergoing Radical Prostatectomy
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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single group assignment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-24', 'studyFirstSubmitDate': '2024-06-02', 'studyFirstSubmitQcDate': '2024-06-06', 'lastUpdatePostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability]', 'timeFrame': '21 Days', 'description': 'Incidence of dose-limiting toxicities (DLTs) over the first 21-days of study treatment'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]', 'timeFrame': 'Time on trial up to 90 days', 'description': 'Incidence of serious adverse events (SAEs), and adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics of STM-416p', 'timeFrame': 'Day 0, post 24 hours, post 48 hour', 'description': 'Maximum plasma concentration (Cmax) of resiquimod (R848) in patient blood'}, {'measure': 'Pharmacodynamics of STM-416p in blood circulating cytokines', 'timeFrame': 'Day 0, post 24 hours, post 48 hours, post 21 days', 'description': 'Pharmacodynamic assessments in plasma and urine will be listed and summarized by dose level'}, {'measure': 'Assess surgical wound healing', 'timeFrame': 'Day 7, Day 21', 'description': 'Assessment of wound healing scored according to a modified ASEPSIS method'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intraoperative', 'Dose escalation', 'Open-label', 'STM-416', 'Resiquimod', 'Toll-like receptor 7/8', 'Radical prostatectomy', 'Robotic prostatectomy', 'Immunotherapy', 'STM-416p', 'PSA', 'R848', 'Hydrogel'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'A Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy', 'detailedDescription': 'A Phase 1 Dose Escalation Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males aged 18 years or older at time of informed consent.\n2. Have a histologically confirmed diagnosis of prostate cancer, and are scheduled to undergo radical prostatectomy within 28 days of screening.\n3. Grade Group 2-5.\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 at Screening.\n5. Have adequate organ and bone marrow function at screening.\n6. Able to understand and be willing to sign an Institutional Review Board/Ethics Committee-approved written informed consent document\n\nExclusion Criteria:\n\n1. Have an invasive malignancy, other than the disease under study.\n2. Anticipated to require the use of a drain after radical prostatectomy.\n3. Received any other anticancer therapy (e.g., including but not limited to chemotherapy, biologic therapy, immunotherapy, targeted therapy, endocrine therapy, radiation therapy, intravesical therapy ) within 28 days.\n4. History of allergic reactions attributed to compounds of similar chemical or biologic composition as those used in the STM-416p formulation including poloxamer 407 and sodium hyaluronate.\n5. History of allogeneic organ transplant.\n6. History of primary immunodeficiency.\n7. QTc interval \\>470 msec at Screening.'}, 'identificationModule': {'nctId': 'NCT06450106', 'briefTitle': 'Study of STM-416p Administered to Patients Undergoing Radical Prostatectomy', 'organization': {'class': 'INDUSTRY', 'fullName': 'SURGE Therapeutics'}, 'officialTitle': 'A Phase 1 Dose Escalation Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy', 'orgStudyIdInfo': {'id': 'STM-416p-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'STM-416p', 'description': 'STM-416p', 'interventionNames': ['Drug: STM-416p']}], 'interventions': [{'name': 'STM-416p', 'type': 'DRUG', 'description': 'STM-416p monotherapy', 'armGroupLabels': ['STM-416p']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85715', 'city': 'Tucson', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jasmine Simpson', 'role': 'CONTACT', 'email': 'JSIMPSON@arizonauro.com'}, {'name': 'Susan Kalota, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Arizona Urology Specialists', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '32608', 'city': 'Gainesville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Danielle Geckler', 'role': 'CONTACT'}, {'role': 'CONTACT', 'email': 'd.geckler@ufl.edu'}, {'name': 'Paul Crispen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '3051', 'city': 'Melbourne N.', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Dina Bushell', 'role': 'CONTACT', 'email': 'dina.bushell@apcr.org.au'}, {'name': 'Phil Dundee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Australian Prostate Center'}, {'zip': '3051', 'city': 'Melbourne N.', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Daniel Shokouhi', 'role': 'CONTACT', 'email': 'ctc-urorenal@epworth.org.au'}, {'name': 'Nathan Lawrentschuk, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Epworth HealthCare'}], 'centralContacts': [{'name': 'Kayti Aviano', 'role': 'CONTACT', 'email': 'kayti@surgetx.com', 'phone': '781-605-8632'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SURGE Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}