Trial | NCT04420689  Report issue

Title

A Study of ALM-488 to Highlight Nerves in Patients Undergoing Head & Neck Surgery
Phase 1/2 Trial of ALM-488 in Patients Undergoing Head & Neck Surgery

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    41
Phase 1/2 study of ALM-488 to highlight nerves in patients undergoing head & neck surgery.
This study will evaluate the safety, tolerability, and efficacy of ALM-488 administered as an intravenous (IV) infusion to patients undergoing head & neck surgery. The study will also characterize the pharmacokinetics of ALM-488 in this subject population and determine the dose of ALM-488 needed to generate a fluorescence signal in nerve tissue to enable fluorescence recordings and image analysis with an imaging system. The study will also evaluate the effect of timing of ALM-488 administration, relative to surgery, on fluorescence characteristics.
Study Started
Jun 18
2020
Primary Completion
Jun 25
2021
Study Completion
Feb 15
2022
Last Update
Feb 16
2022

Drug ALM-488

ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue.

Dose Escalation/De-Escalation Cohorts Experimental

This arm of the study will include Dose Escalation/De-Escalation cohorts of ALM-488.

Dose Timing Cohorts Experimental

This arm of the study will include Dose Timing cohorts of ALM-488.

Criteria 

Inclusion Criteria:

A neoplasm located in the head and neck.
Primary surgical treatment is by parotidectomy, or thyroidectomy, or cervical neck dissection.
Can understand and is willing to sign a written informed consent document.
≥18 years of age.
Life expectancy of at least 6 months.
Normal liver and kidney functions.
If of childbearing potential, must have a negative urine or serum pregnancy test and be using a medically acceptable form of contraception (e.g., hormonal birth control, intrauterine devices, double-barrier method) or abstinence. The subject, if male, must use a medically acceptable form of contraception (e.g. condom) or abstinence.
Plans to undergo head and neck surgery.

Exclusion Criteria:

Prior radiation or chemotherapy for any prior head and neck neoplasm.
Open surgery in the ipsilateral head and neck within 1 year.
Abnormal cardiac rhythm not controlled with medication, history of stroke, coronary events and/or heart failure within 1 year.
Current evidence of renal disease.
Pregnant or breastfeeding.
Unresolved acute toxicity from prior anti-cancer therapy.
History of fluorescein allergy.
Any other criteria deemed by the Principal Investigator that may prevent the patient from successfully completing the trial.
No Results Posted