Bevonescein to Highlight Nerves in Patients Undergoing Head & Neck Surgery

Alume Biosciences

Status and phase: Completed; Phase 2; Phase 1

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

Treatments: Drug: Bevonescein

Study type: Interventional

Funder types: Industry

Identifiers

NCT04420689

ALM-488-001

Details and patient eligibility

About

Bevonescein to Highlight Nerves in Patients Undergoing Head & Neck Surgery

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

Dose Escalation/De-Escalation Cohorts

Experimental group

Description:

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

Treatment:

Drug: Bevonescein

Dose Timing Cohorts

Experimental group

Description:

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

Treatment:

Drug: Bevonescein