Bevonescein to Highlight Nerves in Patients Undergoing Head & Neck Surgery

Phase 1

Completed

• Conditions: Surgery; Nerve Injury; Imaging; Thyroid Neoplasms; Parotid Neoplasm; Head and Neck Neoplasms
• Interventions: Drug: Bevonescein

• Registration Number: NCT04420689
• Lead Sponsor: Alume Biosciences, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2020-06-03
• Study First Submitted QC: 2020-06-04
• Study First Posted: 2020-06-09
• Study Start: 2020-06-18
• Primary Completion: 2021-06-25
• Study Completion: 2022-02-15
• Results First Submitted: 2022-08-26
• Status Verified: 2025-04
• Results First Submitted QC: 2025-04-23
• Last Update Submitted: 2025-04-23
• Results First Posted: 2025-05-08
• Last Update Posted: 2025-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose Escalation/De-Escalation Cohorts	Bevonescein	This arm of the study will include Dose Escalation/De-Escalation cohorts of Bevonescein (ALM-488).
Dose Timing Cohorts	Bevonescein	This arm of the study will include Dose Timing cohorts of Bevonescein (ALM-488).

Primary Outcome Measures

Name	Time	Method
Safety - The Number of Patients With ALM-488 Related Adverse Events	28 (+5) days	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.

Trial Locations

Locations (3)

Stanford University; 🇺🇸 Stanford, California, United States

Harvard-Mass Eye & Ear; 🇺🇸 Boston, Massachusetts, United States

University of California San Diego; 🇺🇸 San Diego, California, United States