A Study of ALM-488 to Highlight Nerves in Patients Undergoing Head & Neck Surgery

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04420689
• Other study ID #: ALM-488-001
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 18, 2020
• Est. completion date: February 15, 2022

Study information

• Verified date: February 2022
• Source: Alume Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase 1/2 study of ALM-488 to highlight nerves in patients undergoing head & neck surgery.

Description:

This study will evaluate the safety, tolerability, and efficacy of ALM-488 administered as an intravenous (IV) infusion to patients undergoing head & neck surgery. The study will also characterize the pharmacokinetics of ALM-488 in this subject population and determine the dose of 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 ALM-488 administration, relative to surgery, on fluorescence characteristics.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: February 15, 2022
• Est. primary completion date: June 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• ALM-488
ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue.

Locations

Country	Name	City	State
United States	Harvard-Mass Eye & Ear	Boston	Massachusetts
United States	University of California San Diego	San Diego	California
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Alume Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of ALM-488 related Adverse Events	Incidence of ALM-488 related Adverse Events according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.	28 (+5) days
Secondary	Concentration of ALM-488 in blood	Concentration of ALM-488 in blood at varying times following ALM-488 administration.	28 (+5) days
Secondary	Dose determination	To determine the recommended dose of ALM-488.	9 months
Secondary	Timing determination	To evaluate the effect of timing of administration of ALM-488.	3 months