Study in Subjects With Small Primary Choroidal Melanoma | NCT03052127 | Trialant
NCT03052127
Sponsor
Aura Biosciences
Status
Completed
Last Update Posted
Feb 1, 2024Actual
Enrollment
57Actual
Phase
Phase 1Phase 2
Conditions
Uveal Melanoma
Ocular Melanoma
Choroidal Melanoma
Interventions
Light-activated AU-011
Laser Activation
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT03052127
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
AU-011-101
Secondary IDs
Not provided
Brief Title
Study in Subjects With Small Primary Choroidal Melanoma
Official Title
A Phase 1B/2 Open-Label, Ascending Single and Repeat Dose Clinical Trial Designed to Evaluate the Safety and Efficacy of Light-activated AU-011 for the Treatment of Subjects With Small Primary Choroidal Melanoma
Acronym
Not provided
Organization
Aura BiosciencesINDUSTRY
Status Module
Record Verification Date
Jan 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 27, 2017Actual
Primary Completion Date
Jan 26, 2021Actual
Completion Date
Jan 26, 2021Actual
First Submitted Date
Feb 6, 2017
First Submission Date that Met QC Criteria
Feb 9, 2017
First Posted Date
Feb 14, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Dec 19, 2023
Results First Submitted that Met QC Criteria
Jan 30, 2024
Results First Posted Date
Feb 1, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jan 5, 2022
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Feb 1, 2024Actual
Last Update Submitted Date
Jan 30, 2024
Last Update Posted Date
Feb 1, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Aura BiosciencesINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
Yes
Is Unapproved Device
Yes
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The primary objective is to assess the safety, immunogenicity and efficacy of one of three dose levels and repeat dose regimens of Light-activated AU-011 and one or two laser applications for the treatment of subjects with primary choroidal melanoma.
Detailed Description
This is a phase 1B/2 open-label, ascending single and repeat dose clinical trial designed to evaluate the safety and efficacy of Light-activated AU-011 for the treatment of subjects with small primary choroidal melanoma.
Throughout the study, subjects will be monitored through medical and ophthalmic assessments. Subjects will be followed for a total of 2 years.
Conditions Module
Conditions
Uveal Melanoma
Ocular Melanoma
Choroidal Melanoma
Keywords
Uveal melanoma
Eye cancer
Ocular melanoma
Choroidal melanoma
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
57Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Single Low Dose Light-activated AU-011
Experimental
Low dose Light-activated AU-011 followed by a single laser light application
Drug: Light-activated AU-011
Device: Laser Activation
Single Medium Dose Light-activated AU-011
Experimental
Medium dose Light-activated AU-011 followed by a single laser light application
Drug: Light-activated AU-011
Device: Laser Activation
Single High Dose Light-activated AU-011
Experimental
High dose Light-activated AU-011 followed by a single laser light application
Drug: Light-activated AU-011
Device: Laser Activation
2 Repeat Medium Dose Light-activated AU-011
Experimental
2 repeat medium doses of Light-activated AU-011 each followed by a single laser light application
Drug: Light-activated AU-011
Device: Laser Activation
3 Repeat Medium Dose Light-activated AU-011
Experimental
3 repeat medium doses of Light-activated AU-011 followed by a single laser light application
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Light-activated AU-011
Drug
Study treatment
2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 lasers
2 Repeat Medium Dose Light-activated AU-011
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011
Adverse events will be summarized by presenting the number and percentage of participants having any adverse event.
Informed consent through 1-2 years
Secondary Outcomes
Measure
Description
Time Frame
Immunogenicity (Anti-AU-011 Antibody Analysis)
Percentage of Participants with Anti-AU-011 Antibodies (Anti-Drug Antibody, ADA)
Screening to various time points through 24 months
Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Diagnosis of choroidal melanoma
Exclusion Criteria:
Have known contraindications or sensitivities to the study drug
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Abhijit Narvekar, MBBS
Aura Biosciences
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Retina Associates SW, P.C.
Tucson
Arizona
85710
United States
UCLA Jules Stein Eye Institute
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
This open-label, multicenter, dose escalation trial with expansion cohorts was designed to evaluate the safety, immunogenicity, and efficacy of up to 2 treatment cycles of intravitreal (IVT) AU-011 aimed to enroll approximately 60 participants with small primary CM. The tables were created for overall and by cohort as part of the study design. Each study participant contributed only 1 eye (study eye).
Recruitment Details
A total of 57 participants with Primary Choroidal Melanoma at 15 sites in the USA were enrolled and 56 were treated with at least 1 dose of AU-011 at 3 dose levels and repeat dose regimens in 1 or 2 treatment cycles with 1 or 2 laser applications.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort 1 (Light-activated AU-011)
Low dose (20 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
FG001
Cohort 2 (Single Medium Dose Light-activated AU-011)
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Feb 21, 2020
Dec 19, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: Light-activated AU-011
Device: Laser Activation
Single High Dose Light-activated AU-011 x 2 lasers
Experimental
High dose Light-activated AU-011 followed by two laser light applications
Drug: Light-activated AU-011
Device: Laser Activation
3 Repeat High Dose Light-activated AU-011
Experimental
3 repeat high doses of Light-activated AU-011 each followed by a single laser light application
Drug: Light-activated AU-011
Device: Laser Activation
3 Repeat High Dose Light-activated AU-011 x 2 lasers
Experimental
3 repeat high doses of Light-activated AU-011 each followed by two laser light applications
Drug: Light-activated AU-011
Device: Laser Activation
Expansion 3 Repeat High Dose Light-activated AU-011 x 2 lasers
Experimental
Expansion of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications (up to 12 additional subjects)
Drug: Light-activated AU-011
Device: Laser Activation
Observation until Documented Growth of Tumor
Experimental
Observation until documented growth of tumor and then treatment with 2 cycles each of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications
Drug: Light-activated AU-011
Device: Laser Activation
2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 lasers
Experimental
2 cycles each of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications
Drug: Light-activated AU-011
Device: Laser Activation
Exp: 2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers
Experimental
2 cycles each of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications in subjects with evidence of documented tumor growth prior to study entry
Drug: Light-activated AU-011
Device: Laser Activation
3 Repeat High Dose Light-activated AU-011
3 Repeat High Dose Light-activated AU-011 x 2 lasers
3 Repeat Medium Dose Light-activated AU-011
Exp: 2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers
Expansion 3 Repeat High Dose Light-activated AU-011 x 2 lasers
Observation until Documented Growth of Tumor
Single High Dose Light-activated AU-011
Single High Dose Light-activated AU-011 x 2 lasers
Single Low Dose Light-activated AU-011
Single Medium Dose Light-activated AU-011
Laser Activation
Device
Study treatment
2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 lasers
2 Repeat Medium Dose Light-activated AU-011
3 Repeat High Dose Light-activated AU-011
3 Repeat High Dose Light-activated AU-011 x 2 lasers
3 Repeat Medium Dose Light-activated AU-011
Exp: 2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers
Expansion 3 Repeat High Dose Light-activated AU-011 x 2 lasers
Observation until Documented Growth of Tumor
Single High Dose Light-activated AU-011
Single High Dose Light-activated AU-011 x 2 lasers
Single Low Dose Light-activated AU-011
Single Medium Dose Light-activated AU-011
PDT Laser
Change from Baseline in maximum tumor thickness (in millimeters) assessed at each study visit using B-scan ultrasound.
Change from baseline following treatment and at each subsequent visit through Week 52
Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]
Change from Baseline in tumor Largest Basal Diameter (LBD) assessed at each study visit based on fundus photos (millimeters) in participants treated with AU-011.
Change from baseline following treatment and at each subsequent visit through Week 52
Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye
Change from Baseline in Best Corrected Visual Acuity using ETDRS letters in Study Eye at each study visit.
Change from baseline following treatment and at each subsequent visit through Week 52
Los Angeles
California
90095
United States
Byers Eye Institute at Stanford University
Palo Alto
California
94303
United States
Retina Consultants of Sacramento
Sacramento
California
95819
United States
Colorado Retina Associates
Denver
Colorado
80210
United States
Massachusetts Eye and Ear Infirmary
Boston
Massachusetts
02114
United States
W. K. Kellogg Eye Center, University of Michigan
Ann Arbor
Michigan
48105
United States
Associated Retinal Consultants, PC
Royal Oak
Michigan
48073
United States
Retina Center
Minneapolis
Minnesota
55404
United States
Columbia University Medical Center
New York
New York
10027
United States
Wills Eye Hospital
Philadelphia
Pennsylvania
19107
United States
Retina Consultants of Carolina, PA
Greenville
South Carolina
29605
United States
Retina Consultants of Houston
Houston
Texas
77030
United States
Medium dose (40 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
FG002
Cohort 3 (Single High Dose Light-activated AU-011)
High dose (80 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
FG003
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)
2 repeat medium doses (40 µg) of Light-activated AU-011 each followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
FG004
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)
3 repeat medium doses (40 µg) of Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
FG005
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)
High dose (80 µg) Light-activated AU-011 followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
FG006
Cohort 7 (3 Repeat High Dose Light-activated AU-011)
3 repeat high doses (80 µg) of Light-activated AU-011 each followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
FG007
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)
3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
FG008
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)
Expansion of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications once for 3 weeks with potential for retreatment
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
FG009
Cohort 10 (Observation Until Documented Growth of Tumor)
Expansion - Observation until documented growth of tumor and then treatment with 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
FG010
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)
Expansion - 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
FG011
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011 x 2 Lasers)
Expansion: 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications in subjects with evidence of documented tumor growth prior to study entry
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG0043 subjects
FG0053 subjects
FG0063 subjects
FG0073 subjects
FG00812 subjects
FG0093 subjects
FG0105 subjects
FG01113 subjects
COMPLETED
FG0002 subjects
FG0013 subjects
FG0022 subjects
FG0033 subjects
FG0042 subjects
FG0052 subjects
FG0062 subjects
FG0072 subjects
FG0087 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0041 subjects
FG0051 subjects
FG0061 subjects
FG0071 subjects
FG0085 subjects
FG0093 subjects
FG0105 subjects
FG01113 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0081 subjects
FG0091 subjects
FG0100 subjects
FG0110 subjects
Discontinuation by Sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Inability to comply with trial requirements
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
COVID-19 restrictions and Investigator discretion
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
The intention-to-treat (ITT) population defined as all enrolled participants, whether or not they received an administration of AU-011 was used for baseline characteristics.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 1 (Light-activated AU-011)
Low dose (20 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
BG001
Cohort 2 (Single Medium Dose Light-activated AU-011)
Medium dose (40 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
BG002
Cohort 3 (Single High Dose Light-activated AU-011)
High dose (80 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
BG003
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)
2 repeat medium doses (40 µg) of Light-activated AU-011 each followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
BG004
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)
3 repeat medium doses (40 µg) of Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
BG005
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)
High dose (80 µg) Light-activated AU-011 followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
BG006
Cohort 7 (3 Repeat High Dose Light-activated AU-011)
3 repeat high doses (80 µg) of Light-activated AU-011 each followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
BG007
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)
3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
BG008
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)
Expansion of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications once for 3 weeks with potential for retreatment
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
BG009
Cohort 10 (Observation Until Documented Growth of Tumor)
Expansion - Observation until documented growth of tumor and then treatment with 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
BG010
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)
Expansion - 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
BG011
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)
Expansion: 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications in subjects with evidence of documented tumor growth prior to study entry
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
BG012
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0013
BG0023
BG0033
BG0043
BG0053
BG0063
BG0073
BG00812
BG0093
BG0105
BG01113
BG01257
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00052.7± 6.51
BG00161.3± 10.02
BG00265.3± 5.13
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0012
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0011
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG0003
BG0013
BG002
Baseline Tumor Characteristics
Tumor thickness assessed using B-scan/ultrasound (reported by independent reading center). Tumor largest basal diameter, distance from fovea, distance from nerve edge - assessed by fundus photography (reported by independent reading center).
Mean
Standard Deviation
millimeters
Title
Denominators
Categories
Tumor lesion thickness
Title
Measurements
BG0001.9± 0.58
BG001
Baseline Risk factors
Risk factors for diagnosis and growth/progression of primary choroidal melanoma include documented growth, subretinal fluid, presence of orange pigment, decreased vision caused by the tumor, and visual symptoms such as flashes/floaters etc.
Count of Participants
Participants
Title
Denominators
Categories
Documented Growth
Title
Measurements
BG0003
BG001
Visual Acuity Scores (ETDRS Letters) in Both Eyes
Visual Acuity assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) method in the intention-to treat (ITT) population
Mean
Standard Deviation
letters on ETDRS scale
Title
Denominators
Categories
Study Eye
Title
Measurements
BG00089.7± 0.58
BG001
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011
Adverse events will be summarized by presenting the number and percentage of participants having any adverse event.
All participants who received at least 1 dose of AU-011 were used for safety analyses.
Adverse events were defined as events that were new or worsened during the treatment period.
AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria [v4.03]).
Posted
Count of Participants
Participants
Informed consent through 1-2 years
ID
Title
Description
OG000
Cohort 1 (Light-activated AU-011)
Low dose (20 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG001
Cohort 2 (Single Medium Dose Light-activated AU-011)
Medium dose (40 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG002
Cohort 3 (Single High Dose Light-activated AU-011)
High dose (80 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG003
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)
2 repeat medium doses (40 µg) of Light-activated AU-011 each followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG004
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)
3 repeat medium doses (40 µg) of Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG005
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)
High dose (80 µg) Light-activated AU-011 followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG006
Cohort 7 (3 Repeat High Dose Light-activated AU-011)
3 repeat high doses (80 µg) of Light-activated AU-011 each followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG007
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)
3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG008
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)
Expansion of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications once for 3 weeks with potential for retreatment
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG009
Cohort 10 (Observation Until Documented Growth of Tumor)
Expansion - Observation until documented growth of tumor and then treatment with 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG010
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)
Expansion - 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG011
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)
Expansion: 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications in subjects with evidence of documented tumor growth prior to study entry
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0003
OG0013
OG0023
OG003
Secondary
Immunogenicity (Anti-AU-011 Antibody Analysis)
Percentage of Participants with Anti-AU-011 Antibodies (Anti-Drug Antibody, ADA)
Subjects who had at least one post-AU-011 dose result were defined in this study as being evaluable for assessment of treatment-induced antibodies to AU-011.
Negative ADA refers to all negative values at baseline and post-treatment Treatment-induced ADA refers to negative value at baseline and at least 1 positive result post-treatment Treatment-unaffected ADA refers to positive value at baseline and at least 1 reported result post-treatment
Posted
Count of Participants
Participants
Screening to various time points through 24 months
ID
Title
Description
OG000
Cohort 1 (Light-activated AU-011)
Low dose (20 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG001
Cohort 2 (Single Medium Dose Light-activated AU-011)
Medium dose (40 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG002
Cohort 3 (Single High Dose Light-activated AU-011)
High dose (80 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
Secondary
Tumor Size (Thickness) Measured by Ultrasonography [Efficacy]
Change from Baseline in maximum tumor thickness (in millimeters) assessed at each study visit using B-scan ultrasound.
The intention-to-treat (ITT) population was defined as all enrolled participants, whether or not they received an administration of AU-011.
Note: The Baseline tumor thickness (TT) values reported for Cohort 10 in the table below (i.e., 2.583 (0.542)) includes only 2 participants who received AU-011. However, the TT values reported in the Baseline Characteristics table (i.e., 2.6 (0.38) includes 3 participants enrolled in the study (ITT population).
Posted
Mean
Standard Deviation
millimeters
Change from baseline following treatment and at each subsequent visit through Week 52
ID
Title
Description
OG000
Cohort 1 (Light-activated AU-011)
Low dose (20 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG001
Cohort 2 (Single Medium Dose Light-activated AU-011)
Medium dose (40 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG002
Cohort 3 (Single High Dose Light-activated AU-011)
Secondary
Tumor Size (Diameter) Measured by Fundus Photography [Efficacy]
Change from Baseline in tumor Largest Basal Diameter (LBD) assessed at each study visit based on fundus photos (millimeters) in participants treated with AU-011.
The intention-to-treat (ITT) population was defined as all enrolled participants, whether or not they received an administration of AU-011.
Note: The Baseline tumor Largest Basal Diameter (LBD) values reported for Cohort 10 in the table below (i.e., 10.088 (2.825)) includes only 2 participants who received AU-011. However, the LBD values reported in the Baseline Characteristics table (i.e., 9.7 (2.1) includes 3 participants enrolled in Cohort 10 (ITT population).
Posted
Mean
Standard Deviation
millimeters
Change from baseline following treatment and at each subsequent visit through Week 52
ID
Title
Description
OG000
Cohort 1 (Light-activated AU-011)
Low dose (20 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG001
Cohort 2 (Single Medium Dose Light-activated AU-011)
Medium dose (40 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG002
Cohort 3 (Single High Dose Light-activated AU-011)
Secondary
Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye
Change from Baseline in Best Corrected Visual Acuity using ETDRS letters in Study Eye at each study visit.
The intention-to-treat (ITT) population was defined as all enrolled participants, whether or not they received an administration of AU-011.
Posted
Mean
Standard Deviation
ETDRS letters
Change from baseline following treatment and at each subsequent visit through Week 52
ID
Title
Description
OG000
Cohort 1 (Light-activated AU-011)
Low dose (20 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG001
Cohort 2 (Single Medium Dose Light-activated AU-011)
Medium dose (40 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG002
Cohort 3 (Single High Dose Light-activated AU-011)
High dose (80 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
Time Frame
12 to 24 months
Description
Safety analyses were performed on all participants who received at least 1 dose of AU-011. Only 56 of the 57 enrolled participants received at least 1 dose of AU-011.
Adverse events (AEs) were defined as events that were new or worsened during the treatment period.
AEs were coded using the MedDRA Version 20.0 and were graded according to the National Center Institute Common Terminology Criteria for AEs (NCI-CTCAE criteria [v4.03]).
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Cohort 1 (Light-activated AU-011)
Low dose (20 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
0
3
0
3
3
3
EG001
Cohort 2 (Single Medium Dose Light-activated AU-011)
Medium dose (40 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
0
3
0
3
3
3
EG002
Cohort 3 (Single High Dose Light-activated AU-011)
High dose (80 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
0
3
1
3
3
3
EG003
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)
2 repeat medium doses (40 µg) of Light-activated AU-011 each followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
0
3
0
3
3
3
EG004
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)
3 repeat medium doses (40 µg) of Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
0
3
0
3
3
3
EG005
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)
High dose (80 µg) Light-activated AU-011 followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
0
3
0
3
3
3
EG006
Cohort 7 (3 Repeat High Dose Light-activated AU-011)
3 repeat high doses (80 µg) of Light-activated AU-011 each followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
0
3
0
3
3
3
EG007
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)
3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
0
3
0
3
3
3
EG008
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)
Expansion of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications once for 3 weeks with potential for retreatment
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
0
12
0
12
12
12
EG009
Cohort 10 (Observation Until Documented Growth of Tumor)
Expansion - Observation until documented growth of tumor and then treatment with 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
0
2
0
2
2
2
EG010
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)
Expansion - 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
0
5
2
5
5
5
EG011
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)
Expansion: 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications in subjects with evidence of documented tumor growth prior to study entry
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
0
13
1
13
13
13
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Visual acuity reduced
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected2 at risk
EG0101 events1 affected5 at risk
EG0111 events1 affected13 at risk
Diverticulitis
Infections and infestations
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Papillary renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anterior chamber cell
Eye disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0022 events1 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected3 at risk
EG0062 events1 affected3 at risk
EG0070 events0 affected3 at risk
EG0085 events3 affected12 at risk
EG0091 events1 affected2 at risk
EG0103 events2 affected5 at risk
EG0113 events2 affected13 at risk
Anterior chamber inflammation
Eye disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Conjuctival hemorrhage
Eye disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0015 events2 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Conjuctival hyperemia
Eye disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Corneal edema
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Corneal disorder
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Eye pain
Eye disorders
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Keratic precipitates
Eye disorders
Systematic Assessment
EG0001 affected3 at risk
EG0012 affected3 at risk
EG0021 affected3 at risk
EG003
Lacrimation increased
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Ocular discomfort
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Ocular hypertension
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 affected3 at risk
EG0021 affected3 at risk
EG003
Punctate keratitis
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Retinal pigment epitheliopathy
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Retinal tear
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Visual acuity reduced
Eye disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events2 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Vitreal cells
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vitreous detachment
Eye disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0013 events2 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Vitreous floaters
Eye disorders
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events2 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Vitreous haze
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vitreous opacities
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vitritis
Eye disorders
Systematic Assessment
EG0002 events2 affected3 at risk
EG0013 events3 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Cataract
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Cataract subcapsular
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dry eye
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Eye irritation
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Eyelid edema
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Iris adhesions
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Photophobia
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Retinal depigmentation
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Retinal detachment
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Uveitis
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vision blurred
Eye disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Fatigue
General disorders
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Corneal abrasion
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Intraocular pressured increased
Investigations
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0022 events1 affected3 at risk
EG003
Headache
Nervous system disorders
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Visual field defect
Nervous system disorders
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
CSA states sites may publish or publicly disclose the results of the study after disclosure is given to the Sponsor for review at least 60 days prior to the date of submission for publication. Site agrees to discuss with Sponsor with respect to the presentation of study data and timing of the disclosure.
Point of Contact
Title
Organization
Phone
Extension
Email
Uma Chandrasekaran, Director, Clinical Development Scientist
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)
2 repeat medium doses (40 µg) of Light-activated AU-011 each followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG004
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)
3 repeat medium doses (40 µg) of Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG005
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)
High dose (80 µg) Light-activated AU-011 followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG006
Cohort 7 (3 Repeat High Dose Light-activated AU-011)
3 repeat high doses (80 µg) of Light-activated AU-011 each followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG007
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)
3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG008
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)
Expansion of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications once for 3 weeks with potential for retreatment
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG009
Cohort 10 (Observation Until Documented Growth of Tumor)
Expansion - Observation until documented growth of tumor and then treatment with 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG010
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)
Expansion - 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG011
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)
Expansion: 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications in subjects with evidence of documented tumor growth prior to study entry
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0033
OG0043
OG0053
OG0063
OG0073
OG00812
OG0092
OG0105
OG01113
Title
Denominators
Categories
Title
Measurements
Negative ADA
OG0002
OG0011
OG0023
OG0031
OG0040
OG0052
OG0062
OG0070
OG0084
OG0091
OG0100
OG0111
Treatment-induced ADA
OG0001
OG0012
OG0020
OG0031
OG004
Treatment-unaffected ADA
OG0000
OG0010
OG0020
OG0031
OG004
High dose (80 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG003
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)
2 repeat medium doses (40 µg) of Light-activated AU-011 each followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG004
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)
3 repeat medium doses (40 µg) of Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG005
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)
High dose (80 µg) Light-activated AU-011 followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG006
Cohort 7 (3 Repeat High Dose Light-activated AU-011)
3 repeat high doses (80 µg) of Light-activated AU-011 each followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG007
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)
3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG008
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)
Expansion of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications once for 3 weeks with potential for retreatment
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG009
Cohort 10 (Observation Until Documented Growth of Tumor)
Expansion - Observation until documented growth of tumor and then treatment with 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG010
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)
Expansion - 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG011
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)
Expansion: 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications in subjects with evidence of documented tumor growth prior to study entry
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0033
OG0043
OG0053
OG0063
OG0073
OG00812
OG0093
OG0105
OG01113
Title
Denominators
Categories
Baseline
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG0073
ParticipantsOG00812
ParticipantsOG0092
ParticipantsOG0105
ParticipantsOG01113
Title
Measurements
OG0001.872± 0.576
OG0012.678± 0.734
OG0022.389± 0.347
OG003
Day 2 (Visit 3)
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0031
Day 8 (Visit 4)
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Day 15 (Visit 6)
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Day 29 (Visit 8)
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Week 8 (Visit 10)
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Week 12 (Visit 11)
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Week 26 (Visit 12)
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Week 39 (Visit 13)
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
Week 52 (Visit 14)
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
High dose (80 µg) Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG003
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)
2 repeat medium doses (40 µg) of Light-activated AU-011 each followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG004
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)
3 repeat medium doses (40 µg) of Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG005
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)
High dose (80 µg) Light-activated AU-011 followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG006
Cohort 7 (3 Repeat High Dose Light-activated AU-011)
3 repeat high doses (80 µg) of Light-activated AU-011 each followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG007
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)
3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG008
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)
Expansion of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications once for 3 weeks with potential for retreatment
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG009
Cohort 10 (Observation Until Documented Growth of Tumor)
Expansion - Observation until documented growth of tumor and then treatment with 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG010
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 Lasers)
Expansion - 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG011
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers)
Expansion: 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications in subjects with evidence of documented tumor growth prior to study entry
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0033
OG0043
OG0053
OG0063
OG0073
OG00812
OG0093
OG0105
OG01113
Title
Denominators
Categories
Baseline
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG0073
ParticipantsOG00812
ParticipantsOG0092
ParticipantsOG0105
ParticipantsOG01113
Title
Measurements
OG0007.740± 2.197
OG0018.350± 1.400
OG0027.700± 1.375
OG003
Day 2 (Visit 3)
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0033
Day 8 (Visit 4)
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0033
Day 9 (Visit 5)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0033
Day 15 (Visit 6)
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Day 16 (Visit 7)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 29 (Visit 8)
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Week 6 (Visit 9)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0023
ParticipantsOG0033
Week 8 (Visit 10)
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Week 12 (Visit 11)
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Week 26 (Visit 12)
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
Week 39 (Visit 13)
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0032
Week 52 (Visit 14)
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
OG003
Cohort 4 (2 Repeat Medium Dose Light-activated AU-011)
2 repeat medium doses (40 µg) of Light-activated AU-011 each followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG004
Cohort 5 (3 Repeat Medium Dose Light-activated AU-011)
3 repeat medium doses (40 µg) of Light-activated AU-011 followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG005
Cohort 6 (Single High Dose Light-activated AU-011 x 2 Lasers)
High dose (80 µg) Light-activated AU-011 followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG006
Cohort 7 (3 Repeat High Dose Light-activated AU-011)
3 repeat high doses (80 µg) of Light-activated AU-011 each followed by a single laser light application
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG007
Cohort 8 (3 Repeat High Dose Light-activated AU-011 x 2 Lasers)
3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG008
Cohort 9 (Expansion 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)
Expansion of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications once for 3 weeks with potential for retreatment
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG009
Cohort 10 (Observation Until Documented Growth of Tumor)
Expansion - Observation until documented growth of tumor and then treatment with 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG010
Cohort 11 (2 Cycles of 3 Repeat High Dose Light-activated AU-011 x 2 Lasers)
Expansion - 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications
Light-activated AU-011: Study treatment
Laser Activation: Study treatment
OG011
Cohort 12 (2 Cycles 3 Repeat High Dose Light-activatedAU-011 x 2 Lasers)
Expansion: 2 cycles each of 3 repeat high doses (80 µg) of Light-activated AU-011 each followed by two laser light applications in subjects with evidence of documented tumor growth prior to study entry