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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT03735680

NCT03735680
Completed Phase 2

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with cancer confirmed by a biopsy, and you are scheduled to have surgery to remove the tumor (either a first-time or returning tumor).
  • Part 1 of the trial: Your biopsy has confirmed head and neck squamous cell carcinoma (a type of head and neck cancer) or breast cancer.
  • Part 2 of the trial: Your biopsy has confirmed one of these cancer types: head and neck squamous cell carcinoma, breast cancer, colorectal cancer, prostate cancer, ovarian cancer, bladder/urinary tract cancer, or non-small cell lung cancer.
  • Part 3 of the trial: You have been diagnosed with stage 2 to 4 head and neck squamous cell carcinoma, including cases where the original location of the cancer is unknown.

Who may not be able to join:

  • Your cancer diagnosis was made using a type of biopsy that removed the entire lump or tumor (called an excisional biopsy), rather than taking a small tissue sample.
  • Your surgeon believes that performing imaging of the tumor during your operation would not be possible due to where the tumor is located.
  • Your life expectancy is currently estimated to be less than 12 weeks.
  • You have liver problems, including poor liver function, active hepatitis, or scarring of the liver (cirrhosis) (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 2
Sponsor
OncoNano Medicine, Inc.
Registry
clinicaltrials_gov
Start date
9 August 2019
Est. completion
14 October 2021

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Measure Mean Fluorescence Intensity of Histologically Confirmed Tumor vs Normal Tissue in Patients Undergoing Routine Surgery [Tumor to Background Ratio (TBR)]; Incidence Rate of All Treatment-emergent Adverse Events (TEAEs) From Time of ONM-100 Administration Through Day 28

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov