Back to resultsA Study to Evaluate ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer
Primary Purpose
Breast Cancer, Head and Neck Squamous Cell Carcinoma, Colorectal Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ONM-100
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Biopsy-confirmed diagnosis of primary or recurrent respective tumor type and scheduled to undergo surgical resection
- Part 1: Biopsy-confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC) or breast cancer
- Part 2: Biopsy-confirmed diagnosis of HNSCC, breast cancer, colorectal cancer, prostate cancer, ovarian cancer, urothelial carcinoma and non-small cell lung cancer.
- Part 3: Stage 2 to 4 HNSCC Including T0 or Tx unknown Primary cancers
Exclusion Criteria:
- Histologically diagnosed by an excisional biopsy procedure
- Tumors at sites of which the surgeon would assess that in vivo intraoperative imaging would not be feasible
- Life expectancy <12 weeks
- Hepatic impairment (Child-Pugh score >5) or significant liver disease including active hepatitis or cirrhosis
Sites / Locations
- The University of Pennsylvania
- The University of Texas Southwestern Medical Center
- The University of Texas - M.D. Anderson Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients receiving ONM-100
Arm Description
All patients in this arm will receive ONM-100 for injection and undergo intraoperative imaging.
Outcomes
Primary Outcome Measures
Measure Mean Fluorescence Intensity of Histologically Confirmed Tumor vs Normal Tissue in Patients Undergoing Routine Surgery [Tumor to Background Ratio (TBR)]
Part 1: Evaluate the dose(s) at which ONM-100 fluorescence imaging is feasible at 3±2 hours post dose.
Part 2: Verify the safety and diagnostic performance of ONM-100 compared to standard pathology at the dose(s) and imaging schedule(s) post dose selected from Part 1 for the detection of primary tumors and the metastatic lymph nodes in a variety of solid cancers (which could have included HNSCC, breast cancer, colorectal cancer, urothelial cancer, prostate cancer, ovarian cancer, and/or non-small cell lung carcinoma [NSCLC]).
Part 3: Assess the safety and efficacy (sensitivity and positive predictive value [PPV] of ONM-100 for intraoperative imaging during HNSCC surgery.
Incidence Rate of All Treatment-emergent Adverse Events (TEAEs) From Time of ONM-100 Administration Through Day 28
Evaluate safety at the dose(s) used to assess imaging feasibility and select the dose(s) and imaging schedule(s) post dose that are safe and provide optimal imaging of solid tumors and metastatic lymph nodes; the dose and time post dose chosen for the detection of primary tumors and metastatic lymph nodes could be the same or different.
Secondary Outcome Measures
Evaluate Pharmacokinetic Parameters: Cmax
Evaluate the maximum plasma concentration (Cmax) of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging at doses of 1 mg/kg, 2 mg/kg and 3 mg/kg.
Evaluate Pharmacokinetic Parameters: Tmax
Evaluate the time to Cmax (Tmax) of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2.
Evaluate Pharmacokinetic Parameters: AUC
Evaluate the Area under the time-concentration curve [AUC] of ONM-100 at 1 mg/kg, 2 mg/kg, and 3 mg/kg doses.
Evaluate Pharmacokinetic Parameters: CL
Evaluate Total body clearance [CL] of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2.
Evaluate Pharmacokinetic Parameters: Vz
Evaluate the Volume of distribution [Vz] of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2.
Evaluate Pharmacokinetic Parameters: t1/2
Evaluate the Terminal elimination half-life [t1/2] of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03735680
Brief Title
A Study to Evaluate ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer
Official Title
A Phase 2a, Single-dose, Open-label Study to Evaluate Diagnostic Performance, Safety & Timing of Postdose Imaging of ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer, in Patients With Solid Tumors Undergoing Routine Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
August 9, 2019 (Actual)
Primary Completion Date
October 14, 2021 (Actual)
Study Completion Date
November 18, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OncoNano Medicine, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is to evaluate diagnostic performance, safety and timing of post-dose imaging of ONM-100, an intraoperative fluorescence imaging agent for the detection of cancer in patients with solid tumors undergoing routine surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Head and Neck Squamous Cell Carcinoma, Colorectal Cancer, Prostate Cancer, Ovarian Cancer, Urothelial Carcinoma, Non-small Cell Lung Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients receiving ONM-100
Arm Type
Experimental
Arm Description
All patients in this arm will receive ONM-100 for injection and undergo intraoperative imaging.
Intervention Type
Drug
Intervention Name(s)
ONM-100
Intervention Description
A polymer micelle covalently conjugated to indocyanine green.
Primary Outcome Measure Information:
Title
Measure Mean Fluorescence Intensity of Histologically Confirmed Tumor vs Normal Tissue in Patients Undergoing Routine Surgery [Tumor to Background Ratio (TBR)]
Description
Part 1: Evaluate the dose(s) at which ONM-100 fluorescence imaging is feasible at 3±2 hours post dose.
Part 2: Verify the safety and diagnostic performance of ONM-100 compared to standard pathology at the dose(s) and imaging schedule(s) post dose selected from Part 1 for the detection of primary tumors and the metastatic lymph nodes in a variety of solid cancers (which could have included HNSCC, breast cancer, colorectal cancer, urothelial cancer, prostate cancer, ovarian cancer, and/or non-small cell lung carcinoma [NSCLC]).
Part 3: Assess the safety and efficacy (sensitivity and positive predictive value [PPV] of ONM-100 for intraoperative imaging during HNSCC surgery.
Time Frame
1 day
Title
Incidence Rate of All Treatment-emergent Adverse Events (TEAEs) From Time of ONM-100 Administration Through Day 28
Description
Evaluate safety at the dose(s) used to assess imaging feasibility and select the dose(s) and imaging schedule(s) post dose that are safe and provide optimal imaging of solid tumors and metastatic lymph nodes; the dose and time post dose chosen for the detection of primary tumors and metastatic lymph nodes could be the same or different.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Evaluate Pharmacokinetic Parameters: Cmax
Description
Evaluate the maximum plasma concentration (Cmax) of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging at doses of 1 mg/kg, 2 mg/kg and 3 mg/kg.
Time Frame
6 days
Title
Evaluate Pharmacokinetic Parameters: Tmax
Description
Evaluate the time to Cmax (Tmax) of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2.
Time Frame
6 days
Title
Evaluate Pharmacokinetic Parameters: AUC
Description
Evaluate the Area under the time-concentration curve [AUC] of ONM-100 at 1 mg/kg, 2 mg/kg, and 3 mg/kg doses.
Time Frame
6 days
Title
Evaluate Pharmacokinetic Parameters: CL
Description
Evaluate Total body clearance [CL] of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2.
Time Frame
6 days
Title
Evaluate Pharmacokinetic Parameters: Vz
Description
Evaluate the Volume of distribution [Vz] of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2.
Time Frame
6 days
Title
Evaluate Pharmacokinetic Parameters: t1/2
Description
Evaluate the Terminal elimination half-life [t1/2] of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2.
Time Frame
6 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Biopsy-confirmed diagnosis of primary or recurrent respective tumor type and scheduled to undergo surgical resection
Part 1: Biopsy-confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC) or breast cancer
Part 2: Biopsy-confirmed diagnosis of HNSCC, breast cancer, colorectal cancer, prostate cancer, ovarian cancer, urothelial carcinoma and non-small cell lung cancer.
Part 3: Stage 2 to 4 HNSCC Including T0 or Tx unknown Primary cancers
Exclusion Criteria:
Histologically diagnosed by an excisional biopsy procedure
Tumors at sites of which the surgeon would assess that in vivo intraoperative imaging would not be feasible
Life expectancy <12 weeks
Hepatic impairment (Child-Pugh score >5) or significant liver disease including active hepatitis or cirrhosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trials@OncoNanoMed.com
Organizational Affiliation
OncoNano Medicine, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
The University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
The University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
The University of Texas - M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Study to Evaluate ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer
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