A Study to Evaluate ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03735680
• Other study ID #: ON-1002
• Status: Completed
• Phase: Phase 2
• Start date: August 9, 2019
• Est. completion date: November 18, 2021

Study information

• Verified date: July 2023
• Source: OncoNano Medicine, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 18, 2021
• Est. primary completion date: October 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma
• Colorectal Cancer
• Head and Neck Squamous Cell Carcinoma
• Non-small Cell Lung Cancer
• Ovarian Cancer
• Prostate Cancer
• Squamous Cell Carcinoma of Head and Neck
• Urothelial Carcinoma

Intervention

Drug:
• ONM-100
A polymer micelle covalently conjugated to indocyanine green.

Locations

Country	Name	City	State
United States	The University of Texas Southwestern Medical Center	Dallas	Texas
United States	The University of Texas - M.D. Anderson Cancer Center	Houston	Texas
United States	The University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
OncoNano Medicine, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day
Primary	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.	28 days
Secondary	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.	6 days
Secondary	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.	6 days
Secondary	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.	6 days
Secondary	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.	6 days
Secondary	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.	6 days
Secondary	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.	6 days