Bevonescein to Highlight Nerves in Patients Undergoing Head & Neck Surgery

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

Bevonescein to Highlight Nerves in Patients Undergoing Head & Neck Surgery

Study Overview

• Status: Completed
• Conditions: Head and Neck Neoplasms; Surgery; Thyroid Neoplasms; Nerve Injury; Parotid Neoplasm; Imaging
• Intervention / Treatment: Drug: Bevonescein

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92037
      • University of California San Diego
    • Stanford, California, United States, 94305
      • Stanford University
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Harvard-Mass Eye & Ear

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Escalation/De-Escalation Cohorts; This arm of the study will include Dose Escalation/De-Escalation cohorts of Bevonescein (ALM-488).	Drug: Bevonescein; Bevonescein Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue.; Other Names: ALM-488
Experimental: Dose Timing Cohorts; This arm of the study will include Dose Timing cohorts of Bevonescein (ALM-488).	Drug: Bevonescein; Bevonescein Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue.; Other Names: ALM-488

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety - The Number of Patients With ALM-488 Related Adverse Events	The number of patients with ALM-488 related Adverse Events according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.	28 (+5) days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of ALM-488 in blood	Concentration of ALM-488 in blood at varying times following ALM-488 administration.	28 (+5) days
Dose determination	To determine the recommended dose of ALM-488.	9 months
Timing determination	To evaluate the effect of timing of administration of ALM-488.	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of Peak ALM-488 Concentration in Plasma (Cmax)	Time of peak ALM-488 concentration in plasma following intravenous ALM-488 infusion (hours).	28 (+5) days

Collaborators and Investigators

• Sponsor: Alume Biosciences, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2020
• Primary Completion (Actual): June 25, 2021
• Study Completion (Actual): February 15, 2022

Study Registration Dates

• First Submitted: June 3, 2020
• First Submitted That Met QC Criteria: June 4, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): May 8, 2025
• Last Update Submitted That Met QC Criteria: April 23, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Imaging; Surgery; Fluorescence; Real-time; Intraoperative; Nerve; Highlighting
• Additional Relevant MeSH Terms: Endocrine System Diseases; Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Endocrine Gland Neoplasms; Salivary Gland Diseases; Thyroid Diseases; Mouth Neoplasms; Parotid Diseases; Salivary Gland Neoplasms; Neoplasms; Head and Neck Neoplasms; Thyroid Neoplasms; Parotid Neoplasms
• Other Study ID Numbers: ALM-488-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No