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

Sponsor

Alume Biosciences, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT04420689

Collaborator

(none)

Enrollment

Locations

Arms

19.9

Actual Duration (Months)

13.7

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Parotid Neoplasm Thyroid Neoplasms Head and Neck Neoplasms Surgery Nerve Injury Imaging	Drug: ALM-488	Phase 1/Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

41 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jun 18, 2020

Actual Primary Completion Date :

Jun 25, 2021

Actual Study Completion Date :

Feb 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose Escalation/De-Escalation Cohorts This arm of the study will include Dose Escalation/De-Escalation cohorts of ALM-488.	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.
Experimental: Dose Timing Cohorts This arm of the study will include Dose Timing cohorts of ALM-488.	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.

Arm

Intervention/Treatment

Experimental: Dose Escalation/De-Escalation Cohorts

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

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.

Experimental: Dose Timing Cohorts

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

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.

Outcome Measures

Primary Outcome Measures

Incidence of ALM-488 related Adverse Events [28 (+5) days]
Incidence of ALM-488 related Adverse Events according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

Secondary Outcome Measures

Concentration of ALM-488 in blood [28 (+5) days]
Concentration of ALM-488 in blood at varying times following ALM-488 administration.
Dose determination [9 months]
To determine the recommended dose of ALM-488.
Timing determination [3 months]
To evaluate the effect of timing of administration of ALM-488.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California San Diego	San Diego	California	United States	92037
2	Stanford University	Stanford	California	United States	94305
3	Harvard-Mass Eye & Ear	Boston	Massachusetts	United States	02114