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

Phase 2

Completed

• Conditions: Head and Neck Squamous Cell Carcinoma; Prostate Cancer; Breast Cancer; Colorectal Cancer; Ovarian Cancer; Non-small Cell Lung Cancer; Urothelial Carcinoma
• Interventions: Drug: ONM-100

• Registration Number: NCT03735680
• Lead Sponsor: OncoNano Medicine, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-24
• Study First Submitted QC: 2018-11-07
• Study First Posted: 2018-11-08
• Study Start: 2019-08-09
• Primary Completion: 2021-10-14
• Study Completion: 2021-11-18
• Results First Submitted: 2023-01-16
• Status Verified: 2023-07
• Results First Submitted QC: 2023-07-06
• Last Update Submitted: 2023-07-06
• Results First Posted: 2023-07-07
• Last Update Posted: 2023-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients receiving ONM-100	ONM-100	All patients in this arm will receive ONM-100 for injection and undergo intraoperative imaging.

Primary Outcome Measures

Name	Time	Method
Measure Mean Fluorescence Intensity of Histologically Confirmed Tumor vs Normal Tissue in Patients Undergoing Routine Surgery [Tumor to Background Ratio (TBR)]	1 day	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	28 days	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

Name	Time	Method
Evaluate Pharmacokinetic Parameters: t1/2	6 days	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.
Evaluate Pharmacokinetic Parameters: Cmax	6 days	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	6 days	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	6 days	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	6 days	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	6 days	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.

Trial Locations

Locations (3)

The University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

The University of Texas - M.D. Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

The University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States