NCT04420689

Bevonescein to Highlight Nerves in Patients Undergoing Head & Neck Surgery

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Alume Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-06-18
• Primary completion: 2021-06-25
• Completion: 2022-02-15
• First posted: 2020-06-09
• Last updated: 2025-05-08
• Results posted: 2025-05-08

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study