Bevonescein to Highlight Nerves in Patients Undergoing Head & Neck Surgery

NCT04420689 | Completed Phase 1 Results FDA Drug

• 1 other identifier: ALM-488-001
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Parotid Neoplasm; Thyroid Neoplasms; Head and Neck Neoplasms; Surgery; Nerve Injury; Imaging

Keywords

Nerve; Fluorescence; Surgery; Imaging; Real-time; Intraoperative; Highlighting

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (1)

• Time of Peak ALM-488 Concentration in Plasma (Cmax)

  28 (+5) days

Study Arms (2)

Dose Escalation/De-Escalation Cohorts

EXPERIMENTAL

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

Drug: Bevonescein

Dose Timing Cohorts

EXPERIMENTAL

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

Drug: Bevonescein

Interventions

Bevonescein DRUG

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

Also known as: ALM-488

Dose Escalation/De-Escalation Cohorts; Dose Timing Cohorts

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alume Biosciences, Inc.: lead

Study Sites (3)

University of California San Diego

San Diego, California, 92037, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Harvard-Mass Eye & Ear

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Lee YJ, Orosco RK, Bouvet M, Richmon JD, Berman BJ, Crawford KL, Hom M, Nguyen QT, Rosenthal EL. Intraoperative nerve-specific fluorescence visualization in head and neck surgery: a Phase 1 trial. Nat Commun. 2025 Jul 2;16(1):6060. doi: 10.1038/s41467-025-60737-x.

  PMID: 40595556 DERIVED

MeSH Terms

Conditions

Parotid Neoplasms; Thyroid Neoplasms; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Salivary Gland Neoplasms; Mouth Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Parotid Diseases; Salivary Gland Diseases; Endocrine Gland Neoplasms; Endocrine System Diseases; Thyroid Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Alume Biosciences

brett.berman@alumebiosciences.com

858-922-3966

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a Phase 1/Phase 2 study in patients undergoing Head \& Neck Surgery.

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 9, 2020
• Study Start: June 18, 2020
• Primary Completion: June 25, 2021
• Study Completion: February 15, 2022
• Last Updated: May 8, 2025
• Results First Posted: May 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)