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

• ClinicalTrials.gov Identifier: NCT03735680
• Recruitment Status: Completed
• First Posted: November 8, 2018
• Last Update Posted: February 11, 2022
• Sponsor: OncoNano Medicine, Inc.
• Information provided by (Responsible Party): OncoNano Medicine, Inc.

Tracking Information

• First Submitted Date: October 24, 2018
• First Posted Date: November 8, 2018
• Last Update Posted Date: February 11, 2022
• Actual Study Start Date: August 9, 2019
• Actual Primary Completion Date: October 14, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 12, 2020)

• Measure mean fluorescence intensity of histologically confirmed tumor vs normal tissue in patients undergoing routine surgery [Tumor to Background Ratio (TBR)] [ Time Frame: 1 day ]
• Incidence rate of all treatment-emergent adverse events (TEAEs) from time of ONM-100 administration through Day 28 [ Time Frame: 28 days ]

Original Primary Outcome Measures (submitted: November 7, 2018)

• Measure mean fluorescence intensity of histologically confirmed tumor vs normal tissue in patients undergoing routine surgery [Tumor to Background Ratio (TBR)] [ Time Frame: 1 day ]
• Incidence rate of all treatment-emergent adverse events (TEAEs) from time of ONM-100 administration through Day 14 [ Time Frame: 14 days ]

Current Secondary Outcome Measures (submitted: February 12, 2020)

• Evaluate pharmacokinetic parameters: Cmax [ Time Frame: 6 days ]
  Maximum plasma concentration [Cmax]
• Evaluate pharmacokinetic parameters: Tmax [ Time Frame: 6 days ]
  Time to Cmax [Tmax]
• Evaluate pharmacokinetic parameters: AUC [ Time Frame: 6 days ]
  Area under the time-concentration curve [AUC]
• Evaluate pharmacokinetic parameters: CL [ Time Frame: 6 days ]
  Total body clearance [CL]
• Evaluate pharmacokinetic parameters: Vss [ Time Frame: 6 days ]
  Volume of distribution [Vss]
• Evaluate pharmacokinetic parameters: t1/2 [ Time Frame: 6 days ]
  Terminal elimination half-life [t1/2]

Original Secondary Outcome Measures (submitted: November 7, 2018)

• Evaluate pharmacokinetic parameters: Cmax [ Time Frame: 9 days ]
  Maximum plasma concentration [Cmax]
• Evaluate pharmacokinetic parameters: Tmax [ Time Frame: 9 days ]
  Time to Cmax [Tmax]
• Evaluate pharmacokinetic parameters: AUC [ Time Frame: 9 days ]
  Area under the time-concentration curve [AUC]
• Evaluate pharmacokinetic parameters: CL [ Time Frame: 9 days ]
  Total body clearance [CL]
• Evaluate pharmacokinetic parameters: Vss [ Time Frame: 9 days ]
  Volume of distribution [Vss]
• Evaluate pharmacokinetic parameters: t1/2 [ Time Frame: 9 days ]
  Terminal elimination half-life [t1/2]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic

Condition

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

Intervention

Drug: ONM-100

A polymer micelle covalently conjugated to indocyanine green, an FDA-approved fluorophore

Study Arms

Experimental: Patients receiving ONM-100

All patients in this arm will receive ONM-100 for injection and undergo intraoperative imaging.

Intervention: Drug: ONM-100

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 14, 2021): 30
• Original Estimated Enrollment (submitted: November 7, 2018): 45
• Actual Study Completion Date: November 18, 2021
• Actual Primary Completion Date: October 14, 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03735680
• Other Study ID Numbers: ON-1002
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: OncoNano Medicine, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: OncoNano Medicine, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Trials@OncoNanoMed.com; OncoNano Medicine, Inc.

• PRS Account: OncoNano Medicine, Inc.
• Verification Date: February 2022