Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 2:17 AM
Study NCT ID:
NCT05226494
Status:
RECRUITING
Last Update Posted:
2025-06-04
First Post:
2021-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of Fb-PMT in Recurrent Glioblastoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005910', 'term': 'Glioma'}, {'id': 'D005909', 'term': 'Glioblastoma'}], 'ancestors': [{'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D001254', 'term': 'Astrocytoma'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': '3+3 Dose Escalation with option for cohort expansion'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-29', 'studyFirstSubmitDate': '2021-12-03', 'studyFirstSubmitQcDate': '2022-01-25', 'lastUpdatePostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]', 'timeFrame': '15 months', 'description': 'Determined by the number of Treatment-Emergent Adverse Events, including Dose-Limiting Toxicities per patient.'}, {'measure': 'Incidence of Dose Limiting Toxicities [Safety and Tolerability]', 'timeFrame': '28 Days', 'description': 'Number of participants with a dose-limiting toxicity during the first cycle (28 days) of treatment at their highest dose level administered.'}], 'secondaryOutcomes': [{'measure': 'Establishment of Recommended Phase 2 Dose', 'timeFrame': '28 Days', 'description': 'Maximum Tolerated Dose, as determined by Dose-Limiting Toxicities.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glioblastoma', 'Glioblastoma Multiforme'], 'conditions': ['Glioma, Malignant']}, 'descriptionModule': {'briefSummary': 'Glioblastoma is a highly aggressive and fatal form of primary malignant brain tumor with limited treatment options. fb-PMT affects a large group of cancer cell signaling pathways and thus may be effective in heterogeneous, treatment-resistant tumors such as Glioblastoma. fb-PMT also is actively transported across the blood-brain barrier into the brain. This study is being conducted to determine the dose level for further clinical development of fb-PMT to treat recurrent Glioblastoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proven intracranial glioblastoma, with first or second recurrence\n* On stable or decreasing dose of steroids, if taken prior to screening\n* Baseline MRI (with and without contrast) completed with 5 days of starting fb-PMT\n* Prior completion of and recovery from the effects of standard of care for glioblastoma management with surgery/biopsy and radiotherapy\n* Confirmation of true progressive disease for patients previously treated with interstitial brachytherapy or stereotactic radio surgery\n* Life expectancy of more than three months\n* Karnofsky Performance Status of ≥ 70\n* Hypertension must be well controlled (≤ 95th percentile) on stable doses of medication\n* Adequate bone marrow and organ function, confirmed by laboratory testing at screening\n* Patient or caregiver must be able to store drug under refrigerated conditions, prepare and administer daily subcutaneous injections on a set schedule, and record information in a daily treatment diary\n* Women of childbearing potential must agree to ongoing pregnancy testing and to use medically acceptable contraception for the duration of the study and for 2 months after their last dose of study drug\n* Males must agree to use medically acceptable contraception and refrain from donating sperm for the duration of the study and for 2 months after their last dose of study drug\n\nExclusion Criteria:\n\n* Significant medical illness that is uncontrolled, may obscure toxicity, may dangerously alter drug metabolism, or may compromise ability for study participation\n* History of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off all therapy for that disease for at least 3 months prior to first dose of study drug\n* Use of bevacizumab or any other experimental drug or therapy within 28 days of study treatment\n* Prior therapy with fb-PMT or related drugs\n* Currently pregnant or breastfeeding\n* Active infection or serious intercurrent medical illness\n* Surgery of any type within the preceding 28 days that has not fully healed\n* A serious or non-healing wound, ulcer, or bone fracture\n* A known bleeding diathesis or coagulopathy, or a history of bleeding diathesis within 28 days of study treatment\n* A known thrombophilic condition (i.e., protein S, protein C, or antithrombin III deficiency, Factor V Leiden, Factor II G20210A mutation, homocysteinemia or antiphospholipid antibody syndrome). Testing is not required in patients without thrombophilic history.\n* Evidence of new central nervous system hemorrhage on baseline MRI obtained within 14 days prior to study enrollment\n* Clinically significant cardiovascular event such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening.\n* New York Heart Association classification of heart disease greater than Class 2\n* QTc interval \\> 450 msec in males or \\> 470 msec in females at screening\n* Use of concomitant medications that prolong the QT/QTc interval or risk inducing Torsades de Pointes\n* Use of any concomitant OATP1B1, OATP1B3, or BSEP inhibitors within 14 days or five half-lives (whichever is longer) before starting study drug treatment\n* Abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within 6 months prior to study enrollment\n* A significant vascular disease (e.g., aortic aneurysm requiring surgical repair, deep venous or arterial thrombosis) within the last 6 months prior to study enrollment\n* History of stroke, myocardial infarction, transient ischemic attack (TIA), severe or unstable angina, peripheral vascular disease, or grade II or greater congestive heart failure within the past 6 months\n* History of Torsades de Pointes or risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)'}, 'identificationModule': {'nctId': 'NCT05226494', 'briefTitle': 'Safety and Tolerability of Fb-PMT in Recurrent Glioblastoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'NanoPharmaceuticals LLC'}, 'officialTitle': 'A Phase 1 Trial to Evaluate the Safety and Tolerability of Fb-PMT in Patients With Recurrent Glioblastoma', 'orgStudyIdInfo': {'id': 'NP-100-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (fb-PMT)', 'description': 'Daily subcutaneous injection of fb-PMT in four escalating cohorts to determine maximum tolerated dose, followed by treatment of up to 10 additional patients at maximum tolerated dose.', 'interventionNames': ['Drug: fb-PMT']}], 'interventions': [{'name': 'fb-PMT', 'type': 'DRUG', 'otherNames': ['NP-100', 'NP751'], 'description': 'Daily dosing based on patient weight', 'armGroupLabels': ['Treatment (fb-PMT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nicholas Blondin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Smilow Cancer Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'centralContacts': [{'name': 'Amy L Rodrigues, CCRC', 'role': 'CONTACT', 'email': 'amy.rodrigues@yale.edu', 'phone': '(203) 260-9632'}], 'overallOfficials': [{'name': 'Nicholas Blondin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NanoPharmaceuticals LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}