Trial Outcomes & Findings for Study of Tozuleristide and the Canvas Imaging System in Pediatric Subjects With CNS Tumors Undergoing Surgery (NCT NCT03579602)

Last Updated: 2024-06-27

Results Overview

Sensitivity and specificity of tozuleristide imaged with the Canvas system to fluorescently identify tumor in equivocal tissue will be evaluated based on central pathology consensus assessment of tumor and by imaging operator fluorescence assessment. These measures will be compared to the sensitivity and specificity of surgical designation of tumor (more likely tumor or less likely tumor) under white light. Sensitivity reflects the probability that tumor tissue evaluated is fluorescent. Specificity reflects the probability that normal tissue evaluated is not fluorescent. Equivocal tissues are those that the surgeon considers abnormal but ambiguous as tumor vs. not tumor under normal (white light) conditions.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

118 participants

Primary outcome timeframe

During surgery (which occurs at least 1 hour post tozuleristide administration)

Results posted on

2024-06-27

Participant Flow

118 subjects were enrolled from 9 academic sites

Participant milestones

Participant milestones
Measure	Arm 1 (no Tozuleristide) Subjects randomized to Arm 1 (\~9% of subjects) will not receive tozuleristide but will undergo standard of care neurosurgery and will have imaging performed with the Canvas System. Canvas System: All subjects enrolled in the study will have their tissue imaged with the Canvas System.	Arm 2 (Tozuleristide Treated) Subjects randomized to Arm 2 (\~ 91% of subjects) will be administered tozuleristide at a dose of 15 mg/m\^2 at least 1 hour and no more than 36 hours prior to surgery. They will undergo standard of care neurosurgery and will have imaging performed with the Canvas System. tozuleristide: Tozuleristide will be administered at least 1 hour and no more than 36 hours prior to planned surgical excision of their tumor. Canvas System: All subjects enrolled in the study will have their tissue imaged with the Canvas System.
Overall Study STARTED	11	107
Overall Study Subjects Who Received Tozuleristide Retreatment	2	2
Overall Study COMPLETED	11	104
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1 (no Tozuleristide) Subjects randomized to Arm 1 (\~9% of subjects) will not receive tozuleristide but will undergo standard of care neurosurgery and will have imaging performed with the Canvas System. Canvas System: All subjects enrolled in the study will have their tissue imaged with the Canvas System.	Arm 2 (Tozuleristide Treated) Subjects randomized to Arm 2 (\~ 91% of subjects) will be administered tozuleristide at a dose of 15 mg/m\^2 at least 1 hour and no more than 36 hours prior to surgery. They will undergo standard of care neurosurgery and will have imaging performed with the Canvas System. tozuleristide: Tozuleristide will be administered at least 1 hour and no more than 36 hours prior to planned surgical excision of their tumor. Canvas System: All subjects enrolled in the study will have their tissue imaged with the Canvas System.
Overall Study Subject unable to receive study drug	0	2
Overall Study Subject did not complete all study visits as planned	0	1

Baseline Characteristics

Enrolled participants were assessed according to either the Karnofsky Performance Status Score OR the Lansky Performance Status Score (not both). 28 out of the 116 participants enrolled into the study completed the Karnofsky Performance Status Score and 88 out of the 116 participants enrolled into the study completed the Lanksy Performance Status Score. (28 Lansky Assessments + 88 Karnofsky Assessments = 116 assessments \[1 for each participant enrolled into the study\])

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 (no Tozuleristide) n=11 Participants Subjects randomized to Arm 1 (\~9% of subjects) will not receive tozuleristide but will undergo standard of care neurosurgery and will have imaging performed with the Canvas System. Canvas System: All subjects enrolled in the study will have their tissue imaged with the Canvas System.	Arm 2 (Tozuleristide Treated) n=105 Participants Subjects randomized to Arm 2 (\~ 91% of subjects) will be administered tozuleristide at a dose of 15 mg/m\^2 at least 1 hour and no more than 36 hours prior to surgery. They will undergo standard of care neurosurgery and will have imaging performed with the Canvas System. tozuleristide: Tozuleristide will be administered at least 1 hour and no more than 36 hours prior to planned surgical excision of their tumor. Canvas System: All subjects enrolled in the study will have their tissue imaged with the Canvas System.	Total n=116 Participants Total of all reporting groups
Age, Continuous	7.749 years n=11 Participants	9.445 years n=105 Participants	9.284 years n=116 Participants
Sex: Female, Male Female	5 Participants n=11 Participants	40 Participants n=105 Participants	45 Participants n=116 Participants
Sex: Female, Male Male	6 Participants n=11 Participants	65 Participants n=105 Participants	71 Participants n=116 Participants
Ethnicity (NIH/OMB) Ethnicity · Hispanic or Latino	0 Participants n=11 Participants	10 Participants n=105 Participants	10 Participants n=116 Participants
Ethnicity (NIH/OMB) Ethnicity · Not Hispanic or Latino	7 Participants n=11 Participants	72 Participants n=105 Participants	79 Participants n=116 Participants
Ethnicity (NIH/OMB) Ethnicity · Unknown or Not Reported	4 Participants n=11 Participants	23 Participants n=105 Participants	27 Participants n=116 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=11 Participants	3 Participants n=105 Participants	3 Participants n=116 Participants
Race (NIH/OMB) Asian	2 Participants n=11 Participants	7 Participants n=105 Participants	9 Participants n=116 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=11 Participants	2 Participants n=105 Participants	2 Participants n=116 Participants
Race (NIH/OMB) Black or African American	1 Participants n=11 Participants	12 Participants n=105 Participants	13 Participants n=116 Participants
Race (NIH/OMB) White	8 Participants n=11 Participants	71 Participants n=105 Participants	79 Participants n=116 Participants
Race (NIH/OMB) More than one race	0 Participants n=11 Participants	0 Participants n=105 Participants	0 Participants n=116 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=11 Participants	10 Participants n=105 Participants	10 Participants n=116 Participants
Region of Enrollment United States	11 participants n=11 Participants	105 participants n=105 Participants	116 participants n=116 Participants
Weight	27.09 kg n=11 Participants	37.14 kg n=105 Participants	36.19 kg n=116 Participants
Height	121.72 cm n=11 Participants	130.46 cm n=105 Participants	129.63 cm n=116 Participants
BSA	0.9534 m sq n=11 Participants	1.1351 m sq n=105 Participants	1.1178 m sq n=116 Participants
Karnofsky Performance Status Score 100	0 Participants n=2 Participants • Enrolled participants were assessed according to either the Karnofsky Performance Status Score OR the Lansky Performance Status Score (not both). 28 out of the 116 participants enrolled into the study completed the Karnofsky Performance Status Score and 88 out of the 116 participants enrolled into the study completed the Lanksy Performance Status Score. (28 Lansky Assessments + 88 Karnofsky Assessments = 116 assessments \[1 for each participant enrolled into the study\])	12 Participants n=26 Participants • Enrolled participants were assessed according to either the Karnofsky Performance Status Score OR the Lansky Performance Status Score (not both). 28 out of the 116 participants enrolled into the study completed the Karnofsky Performance Status Score and 88 out of the 116 participants enrolled into the study completed the Lanksy Performance Status Score. (28 Lansky Assessments + 88 Karnofsky Assessments = 116 assessments \[1 for each participant enrolled into the study\])	12 Participants n=28 Participants • Enrolled participants were assessed according to either the Karnofsky Performance Status Score OR the Lansky Performance Status Score (not both). 28 out of the 116 participants enrolled into the study completed the Karnofsky Performance Status Score and 88 out of the 116 participants enrolled into the study completed the Lanksy Performance Status Score. (28 Lansky Assessments + 88 Karnofsky Assessments = 116 assessments \[1 for each participant enrolled into the study\])
Karnofsky Performance Status Score 90	2 Participants n=2 Participants • Enrolled participants were assessed according to either the Karnofsky Performance Status Score OR the Lansky Performance Status Score (not both). 28 out of the 116 participants enrolled into the study completed the Karnofsky Performance Status Score and 88 out of the 116 participants enrolled into the study completed the Lanksy Performance Status Score. (28 Lansky Assessments + 88 Karnofsky Assessments = 116 assessments \[1 for each participant enrolled into the study\])	4 Participants n=26 Participants • Enrolled participants were assessed according to either the Karnofsky Performance Status Score OR the Lansky Performance Status Score (not both). 28 out of the 116 participants enrolled into the study completed the Karnofsky Performance Status Score and 88 out of the 116 participants enrolled into the study completed the Lanksy Performance Status Score. (28 Lansky Assessments + 88 Karnofsky Assessments = 116 assessments \[1 for each participant enrolled into the study\])	6 Participants n=28 Participants • Enrolled participants were assessed according to either the Karnofsky Performance Status Score OR the Lansky Performance Status Score (not both). 28 out of the 116 participants enrolled into the study completed the Karnofsky Performance Status Score and 88 out of the 116 participants enrolled into the study completed the Lanksy Performance Status Score. (28 Lansky Assessments + 88 Karnofsky Assessments = 116 assessments \[1 for each participant enrolled into the study\])
Karnofsky Performance Status Score 80	0 Participants n=2 Participants • Enrolled participants were assessed according to either the Karnofsky Performance Status Score OR the Lansky Performance Status Score (not both). 28 out of the 116 participants enrolled into the study completed the Karnofsky Performance Status Score and 88 out of the 116 participants enrolled into the study completed the Lanksy Performance Status Score. (28 Lansky Assessments + 88 Karnofsky Assessments = 116 assessments \[1 for each participant enrolled into the study\])	6 Participants n=26 Participants • Enrolled participants were assessed according to either the Karnofsky Performance Status Score OR the Lansky Performance Status Score (not both). 28 out of the 116 participants enrolled into the study completed the Karnofsky Performance Status Score and 88 out of the 116 participants enrolled into the study completed the Lanksy Performance Status Score. (28 Lansky Assessments + 88 Karnofsky Assessments = 116 assessments \[1 for each participant enrolled into the study\])	6 Participants n=28 Participants • Enrolled participants were assessed according to either the Karnofsky Performance Status Score OR the Lansky Performance Status Score (not both). 28 out of the 116 participants enrolled into the study completed the Karnofsky Performance Status Score and 88 out of the 116 participants enrolled into the study completed the Lanksy Performance Status Score. (28 Lansky Assessments + 88 Karnofsky Assessments = 116 assessments \[1 for each participant enrolled into the study\])
Karnofsky Performance Status Score 70	0 Participants n=2 Participants • Enrolled participants were assessed according to either the Karnofsky Performance Status Score OR the Lansky Performance Status Score (not both). 28 out of the 116 participants enrolled into the study completed the Karnofsky Performance Status Score and 88 out of the 116 participants enrolled into the study completed the Lanksy Performance Status Score. (28 Lansky Assessments + 88 Karnofsky Assessments = 116 assessments \[1 for each participant enrolled into the study\])	1 Participants n=26 Participants • Enrolled participants were assessed according to either the Karnofsky Performance Status Score OR the Lansky Performance Status Score (not both). 28 out of the 116 participants enrolled into the study completed the Karnofsky Performance Status Score and 88 out of the 116 participants enrolled into the study completed the Lanksy Performance Status Score. (28 Lansky Assessments + 88 Karnofsky Assessments = 116 assessments \[1 for each participant enrolled into the study\])	1 Participants n=28 Participants • Enrolled participants were assessed according to either the Karnofsky Performance Status Score OR the Lansky Performance Status Score (not both). 28 out of the 116 participants enrolled into the study completed the Karnofsky Performance Status Score and 88 out of the 116 participants enrolled into the study completed the Lanksy Performance Status Score. (28 Lansky Assessments + 88 Karnofsky Assessments = 116 assessments \[1 for each participant enrolled into the study\])
Karnofsky Performance Status Score 50	0 Participants n=2 Participants • Enrolled participants were assessed according to either the Karnofsky Performance Status Score OR the Lansky Performance Status Score (not both). 28 out of the 116 participants enrolled into the study completed the Karnofsky Performance Status Score and 88 out of the 116 participants enrolled into the study completed the Lanksy Performance Status Score. (28 Lansky Assessments + 88 Karnofsky Assessments = 116 assessments \[1 for each participant enrolled into the study\])	2 Participants n=26 Participants • Enrolled participants were assessed according to either the Karnofsky Performance Status Score OR the Lansky Performance Status Score (not both). 28 out of the 116 participants enrolled into the study completed the Karnofsky Performance Status Score and 88 out of the 116 participants enrolled into the study completed the Lanksy Performance Status Score. (28 Lansky Assessments + 88 Karnofsky Assessments = 116 assessments \[1 for each participant enrolled into the study\])	2 Participants n=28 Participants • Enrolled participants were assessed according to either the Karnofsky Performance Status Score OR the Lansky Performance Status Score (not both). 28 out of the 116 participants enrolled into the study completed the Karnofsky Performance Status Score and 88 out of the 116 participants enrolled into the study completed the Lanksy Performance Status Score. (28 Lansky Assessments + 88 Karnofsky Assessments = 116 assessments \[1 for each participant enrolled into the study\])
Karnofsky Performance Status Score 40	0 Participants n=2 Participants • Enrolled participants were assessed according to either the Karnofsky Performance Status Score OR the Lansky Performance Status Score (not both). 28 out of the 116 participants enrolled into the study completed the Karnofsky Performance Status Score and 88 out of the 116 participants enrolled into the study completed the Lanksy Performance Status Score. (28 Lansky Assessments + 88 Karnofsky Assessments = 116 assessments \[1 for each participant enrolled into the study\])	1 Participants n=26 Participants • Enrolled participants were assessed according to either the Karnofsky Performance Status Score OR the Lansky Performance Status Score (not both). 28 out of the 116 participants enrolled into the study completed the Karnofsky Performance Status Score and 88 out of the 116 participants enrolled into the study completed the Lanksy Performance Status Score. (28 Lansky Assessments + 88 Karnofsky Assessments = 116 assessments \[1 for each participant enrolled into the study\])	1 Participants n=28 Participants • Enrolled participants were assessed according to either the Karnofsky Performance Status Score OR the Lansky Performance Status Score (not both). 28 out of the 116 participants enrolled into the study completed the Karnofsky Performance Status Score and 88 out of the 116 participants enrolled into the study completed the Lanksy Performance Status Score. (28 Lansky Assessments + 88 Karnofsky Assessments = 116 assessments \[1 for each participant enrolled into the study\])
Lansky Performance Status Score 100	5 Participants n=9 Participants • Enrolled participants were assessed according to either the Karnofsky Performance Status Score OR the Lansky Performance Status Score (not both). 28 out of the 116 participants enrolled into the study completed the Karnofsky Performance Status Score and 88 out of the 116 participants enrolled into the study completed the Lanksy Performance Status Score. (28 Lansky Assessments + 88 Karnofsky Assessments = 116 assessments \[1 for each participant enrolled into the study\])	38 Participants n=79 Participants • Enrolled participants were assessed according to either the Karnofsky Performance Status Score OR the Lansky Performance Status Score (not both). 28 out of the 116 participants enrolled into the study completed the Karnofsky Performance Status Score and 88 out of the 116 participants enrolled into the study completed the Lanksy Performance Status Score. (28 Lansky Assessments + 88 Karnofsky Assessments = 116 assessments \[1 for each participant enrolled into the study\])	43 Participants n=88 Participants • Enrolled participants were assessed according to either the Karnofsky Performance Status Score OR the Lansky Performance Status Score (not both). 28 out of the 116 participants enrolled into the study completed the Karnofsky Performance Status Score and 88 out of the 116 participants enrolled into the study completed the Lanksy Performance Status Score. (28 Lansky Assessments + 88 Karnofsky Assessments = 116 assessments \[1 for each participant enrolled into the study\])
Lansky Performance Status Score 90	1 Participants n=9 Participants • Enrolled participants were assessed according to either the Karnofsky Performance Status Score OR the Lansky Performance Status Score (not both). 28 out of the 116 participants enrolled into the study completed the Karnofsky Performance Status Score and 88 out of the 116 participants enrolled into the study completed the Lanksy Performance Status Score. (28 Lansky Assessments + 88 Karnofsky Assessments = 116 assessments \[1 for each participant enrolled into the study\])	25 Participants n=79 Participants • Enrolled participants were assessed according to either the Karnofsky Performance Status Score OR the Lansky Performance Status Score (not both). 28 out of the 116 participants enrolled into the study completed the Karnofsky Performance Status Score and 88 out of the 116 participants enrolled into the study completed the Lanksy Performance Status Score. (28 Lansky Assessments + 88 Karnofsky Assessments = 116 assessments \[1 for each participant enrolled into the study\])	26 Participants n=88 Participants • Enrolled participants were assessed according to either the Karnofsky Performance Status Score OR the Lansky Performance Status Score (not both). 28 out of the 116 participants enrolled into the study completed the Karnofsky Performance Status Score and 88 out of the 116 participants enrolled into the study completed the Lanksy Performance Status Score. (28 Lansky Assessments + 88 Karnofsky Assessments = 116 assessments \[1 for each participant enrolled into the study\])
Lansky Performance Status Score 80	2 Participants n=9 Participants • Enrolled participants were assessed according to either the Karnofsky Performance Status Score OR the Lansky Performance Status Score (not both). 28 out of the 116 participants enrolled into the study completed the Karnofsky Performance Status Score and 88 out of the 116 participants enrolled into the study completed the Lanksy Performance Status Score. (28 Lansky Assessments + 88 Karnofsky Assessments = 116 assessments \[1 for each participant enrolled into the study\])	9 Participants n=79 Participants • Enrolled participants were assessed according to either the Karnofsky Performance Status Score OR the Lansky Performance Status Score (not both). 28 out of the 116 participants enrolled into the study completed the Karnofsky Performance Status Score and 88 out of the 116 participants enrolled into the study completed the Lanksy Performance Status Score. (28 Lansky Assessments + 88 Karnofsky Assessments = 116 assessments \[1 for each participant enrolled into the study\])	11 Participants n=88 Participants • Enrolled participants were assessed according to either the Karnofsky Performance Status Score OR the Lansky Performance Status Score (not both). 28 out of the 116 participants enrolled into the study completed the Karnofsky Performance Status Score and 88 out of the 116 participants enrolled into the study completed the Lanksy Performance Status Score. (28 Lansky Assessments + 88 Karnofsky Assessments = 116 assessments \[1 for each participant enrolled into the study\])
Lansky Performance Status Score 70	1 Participants n=9 Participants • Enrolled participants were assessed according to either the Karnofsky Performance Status Score OR the Lansky Performance Status Score (not both). 28 out of the 116 participants enrolled into the study completed the Karnofsky Performance Status Score and 88 out of the 116 participants enrolled into the study completed the Lanksy Performance Status Score. (28 Lansky Assessments + 88 Karnofsky Assessments = 116 assessments \[1 for each participant enrolled into the study\])	6 Participants n=79 Participants • Enrolled participants were assessed according to either the Karnofsky Performance Status Score OR the Lansky Performance Status Score (not both). 28 out of the 116 participants enrolled into the study completed the Karnofsky Performance Status Score and 88 out of the 116 participants enrolled into the study completed the Lanksy Performance Status Score. (28 Lansky Assessments + 88 Karnofsky Assessments = 116 assessments \[1 for each participant enrolled into the study\])	7 Participants n=88 Participants • Enrolled participants were assessed according to either the Karnofsky Performance Status Score OR the Lansky Performance Status Score (not both). 28 out of the 116 participants enrolled into the study completed the Karnofsky Performance Status Score and 88 out of the 116 participants enrolled into the study completed the Lanksy Performance Status Score. (28 Lansky Assessments + 88 Karnofsky Assessments = 116 assessments \[1 for each participant enrolled into the study\])
Lansky Performance Status Score 30	0 Participants n=9 Participants • Enrolled participants were assessed according to either the Karnofsky Performance Status Score OR the Lansky Performance Status Score (not both). 28 out of the 116 participants enrolled into the study completed the Karnofsky Performance Status Score and 88 out of the 116 participants enrolled into the study completed the Lanksy Performance Status Score. (28 Lansky Assessments + 88 Karnofsky Assessments = 116 assessments \[1 for each participant enrolled into the study\])	1 Participants n=79 Participants • Enrolled participants were assessed according to either the Karnofsky Performance Status Score OR the Lansky Performance Status Score (not both). 28 out of the 116 participants enrolled into the study completed the Karnofsky Performance Status Score and 88 out of the 116 participants enrolled into the study completed the Lanksy Performance Status Score. (28 Lansky Assessments + 88 Karnofsky Assessments = 116 assessments \[1 for each participant enrolled into the study\])	1 Participants n=88 Participants • Enrolled participants were assessed according to either the Karnofsky Performance Status Score OR the Lansky Performance Status Score (not both). 28 out of the 116 participants enrolled into the study completed the Karnofsky Performance Status Score and 88 out of the 116 participants enrolled into the study completed the Lanksy Performance Status Score. (28 Lansky Assessments + 88 Karnofsky Assessments = 116 assessments \[1 for each participant enrolled into the study\])
Received Prior CNS Cancer Surgery Yes	3 Participants n=11 Participants	38 Participants n=105 Participants	41 Participants n=116 Participants
Received Prior CNS Cancer Surgery No	8 Participants n=11 Participants	67 Participants n=105 Participants	75 Participants n=116 Participants
Received Prior CNS Cancer Systemic Therapy, Yes	1 Participants n=11 Participants	22 Participants n=105 Participants	23 Participants n=116 Participants
Received Prior CNS Cancer Systemic Therapy, No	10 Participants n=11 Participants	83 Participants n=105 Participants	93 Participants n=116 Participants
Received Prior CNS Cancer Radiation Therapy Yes	1 Participants n=11 Participants	14 Participants n=105 Participants	15 Participants n=116 Participants
Received Prior CNS Cancer Radiation Therapy No	10 Participants n=11 Participants	91 Participants n=105 Participants	101 Participants n=116 Participants
Recurrent or Progressive Disease for Current Tumor Yes	3 Participants n=11 Participants	33 Participants n=105 Participants	36 Participants n=116 Participants
Recurrent or Progressive Disease for Current Tumor No	8 Participants n=11 Participants	72 Participants n=105 Participants	80 Participants n=116 Participants
Evidence of Metastatic Disease Yes	0 Participants n=11 Participants	10 Participants n=105 Participants	10 Participants n=116 Participants
Evidence of Metastatic Disease No	11 Participants n=11 Participants	91 Participants n=105 Participants	102 Participants n=116 Participants
Evidence of Metastatic Disease Unknown	0 Participants n=11 Participants	4 Participants n=105 Participants	4 Participants n=116 Participants

PRIMARY outcome

Timeframe: During surgery (which occurs at least 1 hour post tozuleristide administration)

Population: (Group 2) Subjects who receive tozuleristide, have at least one fluorescence-positive study tissue specimens of any type (primary, equivocal, and other) based on imaging operator fluorescence assessment, and the subject's central pathology consensus diagnosis is tumor, ambiguous, or not definitive.

Outcome measures

Outcome measures
Measure	Group 2 n=156 Equivocal Tissue Biopsies Group 2 (Arm 2 Fluorescent): subjects who receive tozuleristide, have at least one fluorescence-positive study tissue specimens of any type (primary, equivocal and other) based on imaging operator fluorescence assessment, and the subject's central pathology consensus diagnosis is tumor, ambiguous, or not definitive
Sensitivity and Specificity of Tozuleristide Fluorescence to Detect Tumor in Equivocal (Ambiguous) Tissue During Surgery When Imaged With the Canvas System Sensitivity of Tozuleristide Fluorescence for equivocal tissue biopsies in Group 2	79.8 % of equivocal tissue biopsies Interval 70.2 to 90.9
Sensitivity and Specificity of Tozuleristide Fluorescence to Detect Tumor in Equivocal (Ambiguous) Tissue During Surgery When Imaged With the Canvas System Specificity of Tozuleristide Fluorescence for equivocal tissue biopsies in Group 2	34.7 % of equivocal tissue biopsies Interval 22.5 to 53.6

PRIMARY outcome

Timeframe: During surgery (which occurs at least 1 hour post tozuleristide administration)

Population: Subjects who receive tozuleristide, have at least one fluorescence-positive study tissue specimens of any type (primary, equivocal, and other) based on imaging operator fluorescence assessment, and the subject's central pathology consensus diagnosis is tumor, ambiguous, or not definitive.

Tozuleristide sensitivity as assessed by imaging operator fluorescence assessment compared to sensitivity of surgeon designation of tumor under white light in equivocal tissue biopsies. Sensitivity reflects the probability that tumor tissue evaluated is fluorescent. Equivocal tissues are those that the surgeon considers abnormal but ambiguous as tumor vs. not tumor under normal (white light) conditions.

Outcome measures

Outcome measures
Measure	Group 2 n=156 Equivocal Tissue Biopsies Group 2 (Arm 2 Fluorescent): subjects who receive tozuleristide, have at least one fluorescence-positive study tissue specimens of any type (primary, equivocal and other) based on imaging operator fluorescence assessment, and the subject's central pathology consensus diagnosis is tumor, ambiguous, or not definitive
Ratio of Tozuleristide Sensitivity Compared to Surgeon Sensitivity	1.099 Ratio of sensitivity Interval 0.929 to 1.3

PRIMARY outcome

Timeframe: During surgery (which occurs at least 1 hour post tozuleristide administration)

Tozuleristide specificity as assessed by imaging operator fluorescence assessment compared to specificity of surgeon designation of tumor under white light in equivocal tissue biopsies. Specificity reflects the probability that normal tissue evaluated is not fluorescent. Equivocal tissues are those that the surgeon considers abnormal but ambiguous as tumor vs. not tumor under normal (white light) conditions.

Outcome measures

Outcome measures
Measure	Group 2 n=156 Equivocal Tissue Biopsies Group 2 (Arm 2 Fluorescent): subjects who receive tozuleristide, have at least one fluorescence-positive study tissue specimens of any type (primary, equivocal and other) based on imaging operator fluorescence assessment, and the subject's central pathology consensus diagnosis is tumor, ambiguous, or not definitive
Ratio of Tozuleristide Specificity Compared to Surgeon Specificity	0.614 Ratio of specificity Interval 0.348 to 1.083

Adverse Events

Arm 1 (no Tozuleristide)

Serious events: 4 serious events

Other events: 11 other events

Deaths: 0 deaths

Arm 2 (Tozuleristide Treated)

Serious events: 28 serious events

Other events: 105 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Kristi Harrington

Blaze Bioscience

Phone: 206-535-8144

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Serious adverse events
Measure	Arm 1 (no Tozuleristide) n=11 participants at risk Subjects randomized to Arm 1 (\~9% of subjects) will not receive tozuleristide but will undergo standard of care neurosurgery and will have imaging performed with the Canvas System. Canvas System: All subjects enrolled in the study will have their tissue imaged with the Canvas System.	Arm 2 (Tozuleristide Treated) n=105 participants at risk Subjects randomized to Arm 2 (\~ 91% of subjects) will be administered tozuleristide at a dose of 15 mg/m\^2 at least 1 hour and no more than 36 hours prior to surgery. They will undergo standard of care neurosurgery and will have imaging performed with the Canvas System. tozuleristide: Tozuleristide will be administered at least 1 hour and no more than 36 hours prior to planned surgical excision of their tumor. Canvas System: All subjects enrolled in the study will have their tissue imaged with the Canvas System.
Nervous system disorders Basal ganglia stroke	9.1% 1/11 • Number of events 1 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	0.00% 0/105 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Nervous system disorders Cerebrospinal fluid leakage	9.1% 1/11 • Number of events 1 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	0.95% 1/105 • Number of events 1 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Nervous system disorders Hydrocephalus	0.00% 0/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	4.8% 5/105 • Number of events 5 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Nervous system disorders Headache	0.00% 0/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	2.9% 3/105 • Number of events 3 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Nervous system disorders Depressed Level of Consciousness	0.00% 0/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	0.95% 1/105 • Number of events 1 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Nervous system disorders Dizziness	0.00% 0/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	0.95% 1/105 • Number of events 1 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Nervous system disorders Facial Paresis	0.00% 0/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	0.95% 1/105 • Number of events 1 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Nervous system disorders Lethargy	0.00% 0/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	0.95% 1/105 • Number of events 1 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Nervous system disorders Tremor	0.00% 0/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	0.95% 1/105 • Number of events 1 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Metabolism and nutrition disorders Dehydration	0.00% 0/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	0.95% 1/105 • Number of events 1 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	0.95% 1/105 • Number of events 1 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Eye disorders Vision blurred	0.00% 0/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	0.95% 1/105 • Number of events 1 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Immune system disorders Anaphylactic reaction	0.00% 0/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	0.95% 1/105 • Number of events 1 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Infections and infestations Meningitis	0.00% 0/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	0.95% 1/105 • Number of events 1 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Psychiatric disorders Mental status changes	0.00% 0/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	0.95% 1/105 • Number of events 1 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Injury, poisoning and procedural complications Pneumocephalus	9.1% 1/11 • Number of events 1 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	0.00% 0/105 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Injury, poisoning and procedural complications Pseudomeningocele	0.00% 0/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	0.95% 1/105 • Number of events 1 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Injury, poisoning and procedural complications Posterior fossa syndrome	0.00% 0/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	2.9% 3/105 • Number of events 3 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	9.1% 1/11 • Number of events 1 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	0.00% 0/105 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	0.95% 1/105 • Number of events 1 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Gastrointestinal disorders Anal incontinence	0.00% 0/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	0.95% 1/105 • Number of events 1 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Gastrointestinal disorders Vomiting	0.00% 0/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	1.9% 2/105 • Number of events 2 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.

Other adverse events
Measure	Arm 1 (no Tozuleristide) n=11 participants at risk Subjects randomized to Arm 1 (\~9% of subjects) will not receive tozuleristide but will undergo standard of care neurosurgery and will have imaging performed with the Canvas System. Canvas System: All subjects enrolled in the study will have their tissue imaged with the Canvas System.	Arm 2 (Tozuleristide Treated) n=105 participants at risk Subjects randomized to Arm 2 (\~ 91% of subjects) will be administered tozuleristide at a dose of 15 mg/m\^2 at least 1 hour and no more than 36 hours prior to surgery. They will undergo standard of care neurosurgery and will have imaging performed with the Canvas System. tozuleristide: Tozuleristide will be administered at least 1 hour and no more than 36 hours prior to planned surgical excision of their tumor. Canvas System: All subjects enrolled in the study will have their tissue imaged with the Canvas System.
Gastrointestinal disorders Constipation	36.4% 4/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	36.2% 38/105 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Gastrointestinal disorders Nausea	36.4% 4/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	32.4% 34/105 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Gastrointestinal disorders Vomiting	36.4% 4/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	29.5% 31/105 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Gastrointestinal disorders Dysphagia	0.00% 0/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	5.7% 6/105 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Gastrointestinal disorders Abdominal Pain	9.1% 1/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	3.8% 4/105 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Gastrointestinal disorders Glossitis	9.1% 1/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	0.00% 0/105 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Gastrointestinal disorders Ileus	9.1% 1/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	0.00% 0/105 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Gastrointestinal disorders Pneumatosis intestinalis	9.1% 1/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	0.00% 0/105 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Metabolism and nutrition disorders Hypocalcaemia	9.1% 1/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	25.7% 27/105 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Metabolism and nutrition disorders Hypokalaemia	27.3% 3/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	24.8% 26/105 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Metabolism and nutrition disorders Hyperglycaemia	9.1% 1/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	22.9% 24/105 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Metabolism and nutrition disorders Hyponatraemia	36.4% 4/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	21.9% 23/105 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	15.2% 16/105 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Metabolism and nutrition disorders Decreased appetite	18.2% 2/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	11.4% 12/105 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	6.7% 7/105 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Metabolism and nutrition disorders Alkalosis	18.2% 2/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	5.7% 6/105 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Metabolism and nutrition disorders Hyperkalaemia	9.1% 1/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	1.9% 2/105 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Metabolism and nutrition disorders Hypophosphataemia	9.1% 1/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	1.9% 2/105 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Injury, poisoning and procedural complications Procedural pain	63.6% 7/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	49.5% 52/105 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Injury, poisoning and procedural complications Incision site pain	18.2% 2/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	8.6% 9/105 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Injury, poisoning and procedural complications Pseudomeningocele	18.2% 2/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	4.8% 5/105 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Injury, poisoning and procedural complications Incision site oedema	18.2% 2/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	2.9% 3/105 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Injury, poisoning and procedural complications Wound complication	9.1% 1/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	1.9% 2/105 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Injury, poisoning and procedural complications Incision site erythema	9.1% 1/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	0.95% 1/105 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Injury, poisoning and procedural complications Incision site pruritus	9.1% 1/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	0.95% 1/105 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Injury, poisoning and procedural complications Infusion related reaction	9.1% 1/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	0.95% 1/105 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Injury, poisoning and procedural complications Pneumocephalus	9.1% 1/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	0.95% 1/105 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Injury, poisoning and procedural complications Procedural headache	9.1% 1/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	0.95% 1/105 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Injury, poisoning and procedural complications Incision site complication	9.1% 1/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	0.00% 0/105 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Injury, poisoning and procedural complications Procedural complication	9.1% 1/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	0.00% 0/105 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Injury, poisoning and procedural complications Procedural dizziness	9.1% 1/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	0.00% 0/105 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Blood and lymphatic system disorders Anaemia	54.5% 6/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	58.1% 61/105 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Nervous system disorders Headache	27.3% 3/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	26.7% 28/105 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Nervous system disorders Ataxia	27.3% 3/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	9.5% 10/105 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Nervous system disorders Dizziness	9.1% 1/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	9.5% 10/105 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Nervous system disorders Dysarthria	9.1% 1/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	9.5% 10/105 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Nervous system disorders Hemiparesis	9.1% 1/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	7.6% 8/105 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Nervous system disorders Hydrocephalus	9.1% 1/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	5.7% 6/105 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Nervous system disorders Lethargy	18.2% 2/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	5.7% 6/105 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.
Nervous system disorders Cerebrospinal fluid leakage	9.1% 1/11 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.	3.8% 4/105 • From randomization through three months following surgery, or until start of other tumor-directed therapy, whichever is earlier, up to 3 months. Average time on study was approximately 9 weeks. Serious Adverse Events (AEs) includes all Serious AEs reported, none assessed related to tozuleristide by the investigator. Other AEs includes all treatment-emergent AEs reported in =\>5% of subjects on Arm 1 (no tozuleristide) or Arm 2 (tozuleristide treated). Only the following 5 TEAEs were assessed related to tozuleristide by the investigator, occurring in 1 subject each (1/105 Arm 2 subjects, 0.95%): injection site joint pain, vomiting, proteinuria, hypoalbuminemia, maculopapular rash.