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COMPLETEDPHASE1/PHASE2

Bevonescein to Highlight Nerves in Patients Undergoing Head & Neck Surgery

Phase 1/2 Trial of ALM-488 in Patients Undergoing Head & Neck Surgery

NCT04420689•Alume Biosciences, Inc.

View on ClinicalTrials.gov

Summary

Bevonescein to Highlight Nerves in Patients Undergoing Head \& Neck Surgery

Detailed Description

This study will evaluate the safety, tolerability, and efficacy of Bevonescein (ALM-488) administered as an intravenous (IV) infusion to patients undergoing head \& neck surgery. The study will also characterize the pharmacokinetics of Bevonescein (ALM-488) in this subject population and determine the dose of Bevonescein (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 Bevonescein (ALM-488) administration, relative to surgery, on fluorescence characteristics.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. A neoplasm located in the head and neck.
•2. Primary surgical treatment is by parotidectomy, or thyroidectomy, or cervical neck dissection.
•3. Can understand and is willing to sign a written informed consent document.
•4. ≥18 years of age.
•5. Life expectancy of at least 6 months.
•6. Normal liver and kidney functions.
•7. 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.
•8. Plans to undergo head and neck surgery.

Exclusion Criteria

•1. Prior radiation or chemotherapy for any prior head and neck neoplasm.
•2. Open surgery in the ipsilateral head and neck within 1 year.
•3. Abnormal cardiac rhythm not controlled with medication, history of stroke, coronary events and/or heart failure within 1 year.
•4. Current evidence of renal disease.
•5. Pregnant or breastfeeding.
•6. Unresolved acute toxicity from prior anti-cancer therapy.
•7. History of fluorescein allergy.
•8. Any other criteria deemed by the Principal Investigator that may prevent the patient from successfully completing the trial.

Locations (3)

University of California San Diego

San Diego, California, United States

Stanford University

Stanford, California, United States

Harvard-Mass Eye & Ear

Boston, Massachusetts, United States

Key Dates

Start Date

June 18, 2020

Primary Completion Date

June 25, 2021

Completion Date

February 15, 2022

Last Updated

May 8, 2025

Enrollment

ACTUAL participants

Conditions

Parotid NeoplasmThyroid NeoplasmsHead and Neck NeoplasmsSurgeryNerve InjuryImaging

Interventions

Bevonescein

DRUG

EMDR Integrative Group Protocol and Individual Treatment for Patients With Cancer: A Pilot Study

NCT07447089

Thyroid NeoplasmsNeoplasm+2 more

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RECRUITINGPHASE3

Head and Neck Cancer Study Project in the Geriatric Population

NCT06998069

Head and Neck Neoplasms

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Bevonescein to Highlight Nerves in Patients Undergoing Head & Neck Surgery

Inclusion Criteria

Exclusion Criteria

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