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

Primary Purpose

Parotid Neoplasm, Thyroid Neoplasms, Head and Neck Neoplasms

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ALM-488
Sponsored by
Alume Biosciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Parotid Neoplasm focused on measuring Nerve, Fluorescence, Surgery, Imaging, Real-time, Intraoperative, Highlighting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of California San Diego
  • Stanford University
  • Harvard-Mass Eye & Ear

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Dose Escalation/De-Escalation Cohorts

Dose Timing Cohorts

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Concentration of ALM-488 in blood
Concentration of ALM-488 in blood at varying times following ALM-488 administration.
Dose determination
To determine the recommended dose of ALM-488.
Timing determination
To evaluate the effect of timing of administration of ALM-488.

Full Information

First Posted
June 3, 2020
Last Updated
February 15, 2022
Sponsor
Alume Biosciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04420689
Brief Title
A Study of ALM-488 to Highlight Nerves in Patients Undergoing Head & Neck Surgery
Official Title
Phase 1/2 Trial of ALM-488 in Patients Undergoing Head & Neck Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 18, 2020 (Actual)
Primary Completion Date
June 25, 2021 (Actual)
Study Completion Date
February 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alume Biosciences, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parotid Neoplasm, Thyroid Neoplasms, Head and Neck Neoplasms, Surgery, Nerve Injury, Imaging
Keywords
Nerve, Fluorescence, Surgery, Imaging, Real-time, Intraoperative, Highlighting

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Model Description
This is a Phase 1/Phase 2 study in patients undergoing Head & Neck Surgery.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose Escalation/De-Escalation Cohorts
Arm Type
Experimental
Arm Description
This arm of the study will include Dose Escalation/De-Escalation cohorts of ALM-488.
Arm Title
Dose Timing Cohorts
Arm Type
Experimental
Arm Description
This arm of the study will include Dose Timing cohorts of ALM-488.
Intervention Type
Drug
Intervention Name(s)
ALM-488
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of ALM-488 related Adverse Events
Description
Incidence of ALM-488 related Adverse Events according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Time Frame
28 (+5) days
Secondary Outcome Measure Information:
Title
Concentration of ALM-488 in blood
Description
Concentration of ALM-488 in blood at varying times following ALM-488 administration.
Time Frame
28 (+5) days
Title
Dose determination
Description
To determine the recommended dose of ALM-488.
Time Frame
9 months
Title
Timing determination
Description
To evaluate the effect of timing of administration of ALM-488.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Harvard-Mass Eye & Ear
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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