Title
A Study to Evaluate ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer
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
Phase
Phase 2Lead Sponsor
OncoNano Medicine, Inc.Study Type
InterventionalStatus
Completed Results PostedIntervention/Treatment
ONM-100Study Participants
30This 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.
A polymer micelle covalently conjugated to indocyanine green.
All patients in this arm will receive ONM-100 for injection and undergo intraoperative imaging.
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
| Event Type | Organ System | Event Term | Part 1, Cohort A | Part 1, Cohort B | Part 1, Cohort E | Part 2, Group 2 | Part 2, Group 3 | Part 3 |
|---|
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.
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.
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 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 the Area under the time-concentration curve [AUC] of ONM-100 at 1 mg/kg, 2 mg/kg, and 3 mg/kg doses.
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 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 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.
