Trial Outcomes & Findings for Fluorescence Detection of Adult Primary Central Nervous System Tumors With Tozuleristide and the Canvas System (NCT NCT04743310)

NCT ID: NCT04743310

Last Updated: 2026-07-10

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

50 participants

Primary outcome timeframe

At the time of surgery

Results posted on

2026-07-10

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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	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	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
Overall Study STARTED	38	8	4
Overall Study COMPLETED	34	8	4
Overall Study NOT COMPLETED	4	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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	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
Overall Study Withdrawal by Subject	1	0	0
Overall Study Canvas device deficiency	1	0	0
Overall Study Physician Decision	2	0	0

Baseline Characteristics

Fluorescence Detection of Adult Primary Central Nervous System Tumors With Tozuleristide and the Canvas System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: Enhancing (High Grade) CNS Tumors n=38 Participants 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	Cohort 2: Non-enhancing CNS Tumors n=8 Participants 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	Cohort 3: Vestibular Schwannomas n=4 Participants 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	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants	0 Participants n=265 Participants
Race (NIH/OMB) White	26 Participants n=9 Participants	5 Participants n=27 Participants	3 Participants n=267 Participants	34 Participants n=265 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=9 Participants	7 Participants n=27 Participants	1 Participants n=267 Participants	34 Participants n=265 Participants
Age, Categorical >=65 years	12 Participants n=9 Participants	1 Participants n=27 Participants	3 Participants n=267 Participants	16 Participants n=265 Participants
Age, Continuous	60 years n=9 Participants	47 years n=27 Participants	67 years n=267 Participants	59.5 years n=265 Participants
Sex: Female, Male Female	17 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants	17 Participants n=265 Participants
Sex: Female, Male Male	21 Participants n=9 Participants	8 Participants n=27 Participants	4 Participants n=267 Participants	33 Participants n=265 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants	8 Participants n=265 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=9 Participants	8 Participants n=27 Participants	4 Participants n=267 Participants	42 Participants n=265 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants	0 Participants n=265 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants	0 Participants n=265 Participants
Race (NIH/OMB) Asian	3 Participants n=9 Participants	2 Participants n=27 Participants	1 Participants n=267 Participants	6 Participants n=265 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants	0 Participants n=265 Participants
Race (NIH/OMB) Black or African American	3 Participants n=9 Participants	1 Participants n=27 Participants	0 Participants n=267 Participants	4 Participants n=265 Participants
Race (NIH/OMB) More than one race	5 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants	5 Participants n=265 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants	1 Participants n=265 Participants
Region of Enrollment United States	38 participants n=9 Participants	8 participants n=27 Participants	4 participants n=267 Participants	50 participants n=265 Participants

PRIMARY outcome

Timeframe: At the time of surgery

Population: 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.

Outcome measures

Outcome measures
Measure	Cohort 1: Enhancing (High Grade) CNS Tumors n=33 Participants 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	Cohort 2: Non-enhancing CNS Tumors n=7 Participants 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	Cohort 3: Vestibular Schwannomas n=4 Participants 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
Percentage of Patients With Fluorescence-positive Primary Tumor Biopsy	82.35 percentage of participants	14.29 percentage of participants	100 percentage of participants

PRIMARY outcome

Timeframe: At the time of surgery

Population: 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.

Outcome measures

Outcome measures
Measure	Cohort 1: Enhancing (High Grade) CNS Tumors n=131 Tumor-positive Biopsies 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	Cohort 2: Non-enhancing CNS Tumors n=35 Tumor-positive Biopsies 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	Cohort 3: Vestibular Schwannomas n=19 Tumor-positive Biopsies 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
True Positive Rate of Fluorescence, Defined as the Percentage of Tumor-positive and Fluorescence-positive Tissue Biopsies Among All Tumor-positive Tissue Biopsies	83.97 % tumor+ & fluor + / Tumor+ biopsies	20 % tumor+ & fluor + / Tumor+ biopsies	100 % tumor+ & fluor + / Tumor+ biopsies

PRIMARY outcome

Timeframe: At the time of surgery

Population: 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.

Outcome measures

Outcome measures
Measure	Cohort 1: Enhancing (High Grade) CNS Tumors n=28 Tumor-negative Biopsies 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	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	Cohort 3: Vestibular Schwannomas n=1 Tumor-negative Biopsies 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
True Negative Rate of Fluorescence, Defined as the Percentage of Tumor-negative and Fluorescence-negative Tissue Biopsies Among All Tumor-negative Tissue Biopsies	21.43 % tumor- & fluor - /Tumor- biopsies	—	0 % tumor- & fluor - /Tumor- biopsies

SECONDARY outcome

Timeframe: At the time of surgery

Population: 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.

Outcome measures

Outcome measures
Measure	Cohort 1: Enhancing (High Grade) CNS Tumors n=133 fluorescence-positive tissue biopsies 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	Cohort 2: Non-enhancing CNS Tumors n=7 fluorescence-positive tissue biopsies 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	Cohort 3: Vestibular Schwannomas n=19 fluorescence-positive tissue biopsies 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
Positive Predictive Value of Fluorescence, Defined as the Percentage of Tumor-positive and Fluorescence-positive Tissue Biopsies Among All Fluorescence-positive Tissue Biopsies	83.46 % tumor+ & fluor + /Flour+ biopsies	100 % tumor+ & fluor + /Flour+ biopsies	95 % tumor+ & fluor + /Flour+ biopsies

SECONDARY outcome

Timeframe: At the time of surgery

Population: 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.

Outcome measures

Outcome measures
Measure	Cohort 1: Enhancing (High Grade) CNS Tumors n=6 fluorescence-negative tissue biopsies 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	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	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
Negative Predictive Value of Fluorescence, Defined as the Percentage of Tumor-negative and Fluorescence-negative Tissue Biopsies Among All Fluorescence-negative Tissue Biopsies	22.22 % tumor-& fluor -/Flour- biopsies	—	—

SECONDARY outcome

Timeframe: At the time of surgery

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Cohort 1: Enhancing (High Grade) CNS Tumors n=14 Participants 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	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	Cohort 3: Vestibular Schwannomas n=3 Participants 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
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 Gross total resection (GTR)	2 Participants	—	1 Participants
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 Near total resection	7 Participants	—	1 Participants
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 Subtotal resection	4 Participants	—	1 Participants
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 Biopsy Only	0 Participants	—	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Recorded and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 5

Outcome measures

Outcome measures
Measure	Cohort 1: Enhancing (High Grade) CNS Tumors n=34 Participants 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	Cohort 2: Non-enhancing CNS Tumors n=8 Participants 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	Cohort 3: Vestibular Schwannomas n=4 Participants 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
Incidence of Adverse Events	152 adverse events	24 adverse events	23 adverse events

Adverse Events

Cohort 1: Enhancing (High Grade) CNS Tumors

Serious events: 5 serious events

Other events: 31 other events

Deaths: 0 deaths

Cohort 2: Non-enhancing CNS Tumors

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Cohort 3: Vestibular Schwannomas

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1: Enhancing (High Grade) CNS Tumors n=38 participants at risk 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	Cohort 2: Non-enhancing CNS Tumors n=8 participants at risk 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	Cohort 3: Vestibular Schwannomas n=4 participants at risk 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
Gastrointestinal disorders Dysphagia	2.6% 1/38 • Number of events 1 • 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	0.00% 0/8 • 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	0.00% 0/4 • 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
General disorders Fatigue	2.6% 1/38 • Number of events 1 • 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	0.00% 0/8 • 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	0.00% 0/4 • 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
Musculoskeletal and connective tissue disorders Generalized Muscle Weakness	2.6% 1/38 • Number of events 1 • 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	0.00% 0/8 • 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	0.00% 0/4 • 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
Nervous system disorders Dysphasia	5.3% 2/38 • Number of events 2 • 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	0.00% 0/8 • 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	0.00% 0/4 • 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
Nervous system disorders Encephalopathy	2.6% 1/38 • Number of events 1 • 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	0.00% 0/8 • 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	0.00% 0/4 • 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
Nervous system disorders Hydrocephalus	2.6% 1/38 • Number of events 1 • 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	0.00% 0/8 • 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	0.00% 0/4 • 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
Nervous system disorders Muscle Weakness Right-Sided	2.6% 1/38 • Number of events 1 • 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	0.00% 0/8 • 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	0.00% 0/4 • 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
Nervous system disorders Seizure	2.6% 1/38 • Number of events 1 • 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	0.00% 0/8 • 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	0.00% 0/4 • 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
Surgical and medical procedures Intracranial hemmohage	2.6% 1/38 • Number of events 1 • 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	0.00% 0/8 • 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	0.00% 0/4 • 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
General disorders Fever	0.00% 0/38 • 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	12.5% 1/8 • Number of events 1 • 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	0.00% 0/4 • 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
Infections and infestations Periorbital Edema	0.00% 0/38 • 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	12.5% 1/8 • Number of events 1 • 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	0.00% 0/4 • 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
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/38 • 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	12.5% 1/8 • Number of events 1 • 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	0.00% 0/4 • 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
Infections and infestations Wound Infection	0.00% 0/38 • 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	0.00% 0/8 • 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	25.0% 1/4 • Number of events 1 • 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

Other adverse events

Other adverse events
Measure	Cohort 1: Enhancing (High Grade) CNS Tumors n=38 participants at risk 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	Cohort 2: Non-enhancing CNS Tumors n=8 participants at risk 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	Cohort 3: Vestibular Schwannomas n=4 participants at risk 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
Eye disorders Eyelid Function Disorder	0.00% 0/38 • 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	0.00% 0/8 • 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	25.0% 1/4 • Number of events 1 • 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
Gastrointestinal disorders Vomiting	0.00% 0/38 • 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	0.00% 0/8 • 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	25.0% 1/4 • Number of events 1 • 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
Gastrointestinal disorders Constipation	13.2% 5/38 • Number of events 5 • 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	37.5% 3/8 • Number of events 3 • 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	25.0% 1/4 • Number of events 1 • 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
Gastrointestinal disorders Nausea	7.9% 3/38 • Number of events 3 • 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	25.0% 2/8 • Number of events 2 • 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	25.0% 1/4 • Number of events 1 • 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
General disorders Fatigue	13.2% 5/38 • Number of events 5 • 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	37.5% 3/8 • Number of events 3 • 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	25.0% 1/4 • Number of events 1 • 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
General disorders Facial Pain	0.00% 0/38 • 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	0.00% 0/8 • 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	25.0% 1/4 • Number of events 1 • 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
General disorders General disorders and administration site conditions - Other, specify	7.9% 3/38 • Number of events 8 • 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	12.5% 1/8 • Number of events 1 • 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	0.00% 0/4 • 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
Musculoskeletal and connective tissue disorders Pain in Extremity	5.3% 2/38 • Number of events 2 • 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	0.00% 0/8 • 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	0.00% 0/4 • 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
Nervous system disorders Cognitive Disturbance	10.5% 4/38 • Number of events 4 • 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	0.00% 0/8 • 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	0.00% 0/4 • 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
Nervous system disorders Dysarthria	10.5% 4/38 • Number of events 4 • 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	0.00% 0/8 • 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	0.00% 0/4 • 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
Nervous system disorders Dysphasia	21.1% 8/38 • Number of events 8 • 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	12.5% 1/8 • Number of events 1 • 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	0.00% 0/4 • 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
Nervous system disorders Gait Disturbance	15.8% 6/38 • Number of events 6 • 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	0.00% 0/8 • 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	0.00% 0/4 • 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
Nervous system disorders Headache	28.9% 11/38 • Number of events 12 • 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	37.5% 3/8 • Number of events 3 • 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	50.0% 2/4 • Number of events 2 • 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
Blood and lymphatic system disorders Hypertension	0.00% 0/38 • 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	0.00% 0/8 • 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	25.0% 1/4 • Number of events 1 • 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
Ear and labyrinth disorders Hearing Impaired	0.00% 0/38 • 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	0.00% 0/8 • 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	50.0% 2/4 • Number of events 2 • 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
General disorders Fever	0.00% 0/38 • 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	0.00% 0/8 • 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	25.0% 1/4 • Number of events 1 • 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
Infections and infestations Wound Infection	0.00% 0/38 • 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	0.00% 0/8 • 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	25.0% 1/4 • Number of events 1 • 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
Musculoskeletal and connective tissue disorders Facial Muscle Weakness	0.00% 0/38 • 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	0.00% 0/8 • 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	25.0% 1/4 • Number of events 1 • 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
Musculoskeletal and connective tissue disorders Fatigue	0.00% 0/38 • 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	0.00% 0/8 • 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	25.0% 1/4 • Number of events 1 • 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
Nervous system disorders Dizziness	7.9% 3/38 • Number of events 3 • 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	0.00% 0/8 • 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	50.0% 2/4 • Number of events 2 • 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
Nervous system disorders Facial Muscle Weakness	0.00% 0/38 • 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	0.00% 0/8 • 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	25.0% 1/4 • Number of events 1 • 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
Nervous system disorders Pain	0.00% 0/38 • 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	0.00% 0/8 • 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	25.0% 1/4 • Number of events 1 • 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
Renal and urinary disorders Urinary Frequency	0.00% 0/38 • 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	0.00% 0/8 • 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	25.0% 1/4 • Number of events 1 • 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
Skin and subcutaneous tissue disorders Rash Acneiform	0.00% 0/38 • 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	0.00% 0/8 • 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	25.0% 1/4 • Number of events 1 • 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
Skin and subcutaneous tissue disorders Scalp Pain	0.00% 0/38 • 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	0.00% 0/8 • 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	25.0% 1/4 • Number of events 1 • 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
Eye disorders Photophobia	0.00% 0/38 • 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	12.5% 1/8 • Number of events 1 • 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	0.00% 0/4 • 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
General disorders Generalized Muscle Weakness	0.00% 0/38 • 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	12.5% 1/8 • Number of events 1 • 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	0.00% 0/4 • 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
Immune system disorders Fever	0.00% 0/38 • 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	12.5% 1/8 • Number of events 1 • 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	0.00% 0/4 • 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
Infections and infestations Fever	0.00% 0/38 • 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	12.5% 1/8 • Number of events 1 • 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	0.00% 0/4 • 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
Nervous system disorders Edema Cerebral	0.00% 0/38 • 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	12.5% 1/8 • Number of events 1 • 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	0.00% 0/4 • 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
Nervous system disorders Paresthesia	0.00% 0/38 • 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	12.5% 1/8 • Number of events 1 • 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	0.00% 0/4 • 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
Psychiatric disorders Cognitive Disturbance	0.00% 0/38 • 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	12.5% 1/8 • Number of events 1 • 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	0.00% 0/4 • 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
Respiratory, thoracic and mediastinal disorders Sore Throat	0.00% 0/38 • 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	12.5% 1/8 • Number of events 1 • 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	0.00% 0/4 • 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
Blood and lymphatic system disorders Anemia	5.3% 2/38 • Number of events 2 • 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	0.00% 0/8 • 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	0.00% 0/4 • 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
Eye disorders Blurred Vision	5.3% 2/38 • Number of events 2 • 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	0.00% 0/8 • 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	0.00% 0/4 • 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
Gastrointestinal disorders Dysphagia	5.3% 2/38 • Number of events 2 • 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	0.00% 0/8 • 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	0.00% 0/4 • 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
General disorders Gait Disturbance	5.3% 2/38 • Number of events 2 • 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	0.00% 0/8 • 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	0.00% 0/4 • 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
General disorders Headache	5.3% 2/38 • Number of events 2 • 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	0.00% 0/8 • 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	0.00% 0/4 • 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
General disorders Other	5.3% 2/38 • Number of events 2 • 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	0.00% 0/8 • 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	0.00% 0/4 • 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
Infections and infestations Other	5.3% 2/38 • Number of events 2 • 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	0.00% 0/8 • 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	0.00% 0/4 • 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
Investigations Alanina Aminotransferase Increased	5.3% 2/38 • Number of events 2 • 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	0.00% 0/8 • 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	0.00% 0/4 • 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
Investigations Aspartate Aminotransferase Increased	5.3% 2/38 • Number of events 2 • 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	0.00% 0/8 • 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	0.00% 0/4 • 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
Nervous system disorders Ataxia	5.3% 2/38 • Number of events 2 • 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	0.00% 0/8 • 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	0.00% 0/4 • 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
Nervous system disorders Fatigue	5.3% 2/38 • Number of events 2 • 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	0.00% 0/8 • 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	0.00% 0/4 • 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
Nervous system disorders Memory Impairment	5.3% 2/38 • Number of events 2 • 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	0.00% 0/8 • 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	0.00% 0/4 • 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
Nervous system disorders Nervous System Disorders - Other, Specify	5.3% 2/38 • Number of events 2 • 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	0.00% 0/8 • 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	0.00% 0/4 • 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
Psychiatric disorders Anxiety	5.3% 2/38 • Number of events 2 • 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	0.00% 0/8 • 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	0.00% 0/4 • 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
Psychiatric disorders Confusion	5.3% 2/38 • Number of events 2 • 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	0.00% 0/8 • 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	0.00% 0/4 • 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
Psychiatric disorders Insomnia	5.3% 2/38 • Number of events 2 • 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	0.00% 0/8 • 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	0.00% 0/4 • 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
Renal and urinary disorders Urinary Tract Infection	5.3% 2/38 • Number of events 2 • 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	0.00% 0/8 • 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	0.00% 0/4 • 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
Respiratory, thoracic and mediastinal disorders Aspiration	5.3% 2/38 • Number of events 2 • 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	0.00% 0/8 • 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	0.00% 0/4 • 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
Skin and subcutaneous tissue disorders Other	5.3% 2/38 • Number of events 3 • 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	0.00% 0/8 • 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	0.00% 0/4 • 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

Additional Information

John Yu, MD

Cedars-Sinai Medical Center

Phone: 310-423-7900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place