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| Name | Class |
|---|---|
| Blaze Bioscience Inc. | INDUSTRY |
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The purpose of this study is to examine the use of a single dose of tozuleristide (24 or 36 mg) and the Canvas imaging system during surgical resection of primary central nervous system (CNS) tumors: Primary gadolinium enhancing (high grade) CNS tumors, primary non-gadolinium enhancing CNS tumors, and primary vestibular schwannoma.
The primary objectives of the study is to see how well tozuleristide and the Canvas imaging system during surgical resection will show fluorescence among primary enhancing/high grade CNS tumors; and among the tumors that demonstrate tozuleristide fluorescence, to estimate the true positive rate and true negative rate of fluorescence in tissue biopsies, as well as sensitivity and specificity of tozuleristide fluorescence for distinguishing tumor from non-tumoral tissue.
The secondary objectives of the study include evaluating the safety of tozuleristide and the Canvas imaging system, and to determine if the presence of remaining fluorescence at the time of surgery corresponds to remaining tumor evident on post-operative MRI images, or if the absence of fluorescence corresponds to evidence of no gross residual tumor on post-operative magnetic resonance imaging (MRI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tozuleristide with Canvas imaging system | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tozuleristide | Drug | tozuleristide 24 or 36 mg administered intravenously 1-24 hours prior to surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Fluorescence-positive Primary Tumor Biopsy | At the time of surgery | |
| True Positive Rate of Fluorescence, Defined as the Percentage of Tumor-positive and Fluorescence-positive Tissue Biopsies Among All Tumor-positive Tissue Biopsies | At the time of surgery | |
| True Negative Rate of Fluorescence, Defined as the Percentage of Tumor-negative and Fluorescence-negative Tissue Biopsies Among All Tumor-negative Tissue Biopsies | At the time of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Positive Predictive Value of Fluorescence, Defined as the Percentage of Tumor-positive and Fluorescence-positive Tissue Biopsies Among All Fluorescence-positive Tissue Biopsies | At the time of surgery | |
| Negative Predictive Value of Fluorescence, Defined as the Percentage of Tumor-negative and Fluorescence-negative Tissue Biopsies Among All Fluorescence-negative Tissue Biopsies |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | Recorded and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 5 | From the time of study drug administration 1-24 hours prior to surgery, until 30 days after surgery or until receiving additional therapy for the central nervous system tumor, whichever comes first |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Yu, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
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The trial opened to accrual on 9/27/2021 with first subject enrolled on study 9/30/2021. A total of 56 patients consented; 6 subjects failed screening; 50 subjects were enrolled/went on study/on treatment, 46 completed study intervention, and 45 were deemed evaluable. The last subject went off treatment on 3/5/2025. Last data collection for primary endpoint confirmed on 3/6/2025 as the primary completion date. 0 subjects are in follow-up.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Enhancing (High Grade) CNS Tumors | Tozuleristide: Tozuleristide 24mg administered intravenously 1-24 hours prior to surgery Canvas imaging system: imaging device attached to surgical microscope Surgical resection of tumor: Standard of care surgical resection of tumor |
| FG001 | Cohort 2: Non-enhancing CNS Tumors | Tozuleristide: Tozuleristide 36mg administered intravenously 1-24 hours prior to surgery Canvas imaging system: imaging device attached to surgical microscope Surgical resection of tumor: Standard of care surgical resection of tumor |
| FG002 | Cohort 3: Vestibular Schwannomas | Tozuleristide: Tozuleristide 24mg mgadministered intravenously 1-24 hours prior to surgery Canvas imaging system: imaging device attached to surgical microscope Surgical resection of tumor: Standard of care surgical resection of tumor |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Enhancing (High Grade) CNS Tumors | Tozuleristide: Tozuleristide 24mg administered intravenously 1-24 hours prior to surgery Canvas imaging system: imaging device attached to surgical microscope Surgical resection of tumor: Standard of care surgical resection of tumor |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Patients With Fluorescence-positive Primary Tumor Biopsy | Cohort 1 - One subject is not evaluable for primary outcome since only the primary specimen was collected. Cohort 2 - One subject is not evaluable for primary outcome since they didn't have surgery. | Posted | Number | percentage of participants | At the time of surgery |
|
The investigator or designee is responsible for ensuring that all adverse events (both serious and non-serious) observed by the clinical team or reported by the subject, which occur from start of first dose of study drug and until 30 days following surgery or until subject begins another cancer therapy (whichever occurs first), are fully recorded in the subject's medical records
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: Enhancing (High Grade) CNS Tumors | Tozuleristide: Tozuleristide 24mg administered intravenously 1-24 hours prior to surgery Canvas imaging system: imaging device attached to surgical microscope Surgical resection of tumor: Standard of care surgical resection of tumor |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Yu, MD | Cedars-Sinai Medical Center | 310-423-7900 | yuj@cshs.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 4, 2024 | Jan 6, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 4, 2025 | Jan 6, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D001932 | Brain Neoplasms |
| D013120 | Spinal Cord Neoplasms |
| D005910 | Glioma |
| D001254 | Astrocytoma |
| D005909 | Glioblastoma |
| D004806 | Ependymoma |
| D008527 | Medulloblastoma |
| D010871 | Pinealoma |
| D008579 | Meningioma |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D003397 | Craniopharyngioma |
| D009464 | Neuroma, Acoustic |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000604732 | tozuleristide |
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| Canvas imaging system | Device | imaging device attached to surgical microscope |
|
| Surgical resection of tumor | Procedure | Standard of care surgical resection of tumor |
|
| At the time of surgery |
| Extent of Residual Tumor Measured on Post-operative Magnetic Resonance Imaging Scans Among All Patients With Evidence of Residual Fluorescence at the Time of Surgery | To preliminarily determine if the presence of residual fluorescence at the time of surgery corresponds to residual tumor evident on post-operative MRI images, or if the absence of fluorescence corresponds to evidence of no gross residual tumor on post-operative MRI. This measure reports the number of participants that met the criteria for each extent of resection category based on post-operate MRI findings. In order from best to worst in terms of extent of resection: Gross total resection means no residual gadolinium enhancing tumor on postoperative MRI, Near gross total resection means minimal residual gadolinium enhancing tumor on MRI, less than 0.5 cm cubed, Subtotal resection means residual gadolinium enhancing tumor noted on post operative MRI, and Biopsy only means residual tumor from a biopsy only of the tumor. | At the time of surgery |
| Physician Decision |
|
| Cohort 2: Non-enhancing CNS Tumors |
Tozuleristide: Tozuleristide 36mg administered intravenously 1-24 hours prior to surgery Canvas imaging system: imaging device attached to surgical microscope Surgical resection of tumor: Standard of care surgical resection of tumor |
| BG002 | Cohort 3: Vestibular Schwannomas | Tozuleristide: Tozuleristide 24mg mgadministered intravenously 1-24 hours prior to surgery Canvas imaging system: imaging device attached to surgical microscope Surgical resection of tumor: Standard of care surgical resection of tumor |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Cohort 3: Vestibular Schwannomas | Tozuleristide: Tozuleristide 24mg mgadministered intravenously 1-24 hours prior to surgery Canvas imaging system: imaging device attached to surgical microscope Surgical resection of tumor: Standard of care surgical resection of tumor |
|
|
| Primary | True Positive Rate of Fluorescence, Defined as the Percentage of Tumor-positive and Fluorescence-positive Tissue Biopsies Among All Tumor-positive Tissue Biopsies | Cohort 1 - One subject is not evaluable for primary outcome since only the primary specimen was collected. Cohort 2 - One subject is not evaluable for primary outcome since they didn't have surgery. | Posted | Number | % tumor+ & fluor + / Tumor+ biopsies | At the time of surgery | Tumor-positive Biopsies | Tumor-positive Biopsies |
|
|
|
| Primary | True Negative Rate of Fluorescence, Defined as the Percentage of Tumor-negative and Fluorescence-negative Tissue Biopsies Among All Tumor-negative Tissue Biopsies | Cohort 1 - One subject is not evaluable for primary outcome since only the primary specimen was collected. Cohort 2 - One subject is not evaluable for primary outcome since they didn't have surgery. | Posted | Number | % tumor- & fluor - /Tumor- biopsies | At the time of surgery | Tumor-negative Biopsies | Tumor-negative Biopsies |
|
|
|
| Secondary | Positive Predictive Value of Fluorescence, Defined as the Percentage of Tumor-positive and Fluorescence-positive Tissue Biopsies Among All Fluorescence-positive Tissue Biopsies | Cohort 1 - One subject is not evaluable for primary outcome since only the primary specimen was collected. Cohort 2 - One subject is not evaluable for primary outcome since they didn't have surgery. | Posted | Number | % tumor+ & fluor + /Flour+ biopsies | At the time of surgery | fluorescence-positive tissue biopsies | fluorescence-positive tissue biopsies |
|
|
|
| Secondary | Negative Predictive Value of Fluorescence, Defined as the Percentage of Tumor-negative and Fluorescence-negative Tissue Biopsies Among All Fluorescence-negative Tissue Biopsies | Cohort 1 - One subject is not evaluable for primary outcome since only the primary specimen was collected. Cohort 2 - One subject is not evaluable for primary outcome since they didn't have surgery. | Posted | Number | % tumor-& fluor -/Flour- biopsies | At the time of surgery | fluorescence-negative tissue biopsies | fluorescence-negative tissue biopsies |
|
|
|
| Secondary | Extent of Residual Tumor Measured on Post-operative Magnetic Resonance Imaging Scans Among All Patients With Evidence of Residual Fluorescence at the Time of Surgery | To preliminarily determine if the presence of residual fluorescence at the time of surgery corresponds to residual tumor evident on post-operative MRI images, or if the absence of fluorescence corresponds to evidence of no gross residual tumor on post-operative MRI. This measure reports the number of participants that met the criteria for each extent of resection category based on post-operate MRI findings. In order from best to worst in terms of extent of resection: Gross total resection means no residual gadolinium enhancing tumor on postoperative MRI, Near gross total resection means minimal residual gadolinium enhancing tumor on MRI, less than 0.5 cm cubed, Subtotal resection means residual gadolinium enhancing tumor noted on post operative MRI, and Biopsy only means residual tumor from a biopsy only of the tumor. | Cohort 1 - One subject is not evaluable for primary outcome since only the primary specimen was collected. Cohort 2 - One subject is not evaluable for primary outcome since they didn't have surgery. Number of Participants analyzed represents the number of participants that met the criteria for each extent of resection. | Posted | Number | Participants | At the time of surgery |
|
|
|
| Other Pre-specified | Incidence of Adverse Events | Recorded and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 5 | Posted | Number | adverse events | From the time of study drug administration 1-24 hours prior to surgery, until 30 days after surgery or until receiving additional therapy for the central nervous system tumor, whichever comes first |
|
|
|
| 0 |
| 38 |
| 5 |
| 38 |
| 31 |
| 38 |
| EG001 | Cohort 2: Non-enhancing CNS Tumors | Tozuleristide: Tozuleristide 36mg administered intravenously 1-24 hours prior to surgery Canvas imaging system: imaging device attached to surgical microscope Surgical resection of tumor: Standard of care surgical resection of tumor | 0 | 8 | 2 | 8 | 6 | 8 |
| EG002 | Cohort 3: Vestibular Schwannomas | Tozuleristide: Tozuleristide 24mg mgadministered intravenously 1-24 hours prior to surgery Canvas imaging system: imaging device attached to surgical microscope Surgical resection of tumor: Standard of care surgical resection of tumor | 0 | 4 | 1 | 4 | 4 | 4 |
| Fatigue | General disorders | Systematic Assessment |
|
| Generalized Muscle Weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dysphasia | Nervous system disorders | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | Systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | Systematic Assessment |
|
| Muscle Weakness Right-Sided | Nervous system disorders | Systematic Assessment |
|
| Seizure | Nervous system disorders | Systematic Assessment |
|
| Intracranial hemmohage | Surgical and medical procedures | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Periorbital Edema | Infections and infestations | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Wound Infection | Infections and infestations | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| General disorders and administration site conditions - Other, specify | General disorders | Systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Cognitive Disturbance | Nervous system disorders | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | Systematic Assessment |
|
| Dysphasia | Nervous system disorders | Systematic Assessment |
|
| Gait Disturbance | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Hypertension | Blood and lymphatic system disorders | Systematic Assessment |
|
| Hearing Impaired | Ear and labyrinth disorders | Systematic Assessment |
|
| Eyelid Function Disorder | Eye disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Facial Pain | General disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Wound Infection | Infections and infestations | Systematic Assessment |
|
| Facial Muscle Weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Fatigue | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Facial Muscle Weakness | Nervous system disorders | Systematic Assessment |
|
| Pain | Nervous system disorders | Systematic Assessment |
|
| Urinary Frequency | Renal and urinary disorders | Systematic Assessment |
|
| Rash Acneiform | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Scalp Pain | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Photophobia | Eye disorders | Systematic Assessment |
|
| Generalized Muscle Weakness | General disorders | Systematic Assessment |
|
| Fever | Immune system disorders | Systematic Assessment |
|
| Fever | Infections and infestations | Systematic Assessment |
|
| Edema Cerebral | Nervous system disorders | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | Systematic Assessment |
|
| Cognitive Disturbance | Psychiatric disorders | Systematic Assessment |
|
| Sore Throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Blurred Vision | Eye disorders | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
|
| Gait Disturbance | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Other | General disorders | Systematic Assessment |
|
| Other | Infections and infestations | Systematic Assessment |
|
| Alanina Aminotransferase Increased | Investigations | Systematic Assessment |
|
| Aspartate Aminotransferase Increased | Investigations | Systematic Assessment |
|
| Ataxia | Nervous system disorders | Systematic Assessment |
|
| Fatigue | Nervous system disorders | Systematic Assessment |
|
| Memory Impairment | Nervous system disorders | Systematic Assessment |
|
| Nervous System Disorders - Other, Specify | Nervous system disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Confusion | Psychiatric disorders | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Other | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D018242 | Neuroectodermal Tumors, Primitive |
| D009383 | Neoplasms, Vascular Tissue |
| D008577 | Meningeal Neoplasms |
| D009442 | Neurilemmoma |
| D018358 | Neuroendocrine Tumors |
| D009463 | Neuroma |
| D018317 | Nerve Sheath Neoplasms |
| D003390 | Cranial Nerve Neoplasms |
| D010524 | Peripheral Nervous System Neoplasms |
| D000160 | Vestibulocochlear Nerve Diseases |
| D012181 | Retrocochlear Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D010039 | Otorhinolaryngologic Neoplasms |
| D003389 | Cranial Nerve Diseases |
| Subtotal resection |
|
| Biopsy Only |
|