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

NCT03735680 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ON-1002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Evaluate Pharmacokinetic Parameters: Cmax

  6 days

• Evaluate Pharmacokinetic Parameters: Tmax

  6 days

• Evaluate Pharmacokinetic Parameters: AUC

  6 days

• Evaluate Pharmacokinetic Parameters: CL

  6 days

• Evaluate Pharmacokinetic Parameters: Vz

  6 days

Study Arms (1)

Patients receiving ONM-100

EXPERIMENTAL

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

Drug: ONM-100

Interventions

ONM-100 DRUG

A polymer micelle covalently conjugated to indocyanine green.

Patients receiving ONM-100

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OncoNano Medicine, Inc.: lead

Study Sites (3)

The University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

The University of Texas - M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Squamous Cell Carcinoma of Head and Neck; Colorectal Neoplasms; Prostatic Neoplasms; Ovarian Neoplasms; Carcinoma, Transitional Cell; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Head and Neck Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Neoplasms, Female; Endocrine System Diseases; Gonadal Disorders; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Vice President, Clinical Operations
• Organization: OncoNano Medicine, Inc.

clinicaltrials@onconanomed.com

682-285-1411

Study Officials

• Trials@OncoNanoMed.com

  OncoNano Medicine, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: November 8, 2018
• Study Start: August 9, 2019
• Primary Completion: October 14, 2021
• Study Completion: November 18, 2021
• Last Updated: July 7, 2023
• Results First Posted: July 7, 2023

Record last verified: 2023-07

Locations

US (3)