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

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

Detailed Description
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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.

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

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

Intervention / Treatment
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* Drug: ALM-488


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose Escalation/De-Escalation Cohorts<br>This arm of the study will include Dose Escalation/De-Escalation cohorts of ALM-488. | Drug: ALM-488<br>* 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.<br>|
| Experimental: Dose Timing Cohorts<br>This arm of the study will include Dose Timing cohorts of ALM-488. | Drug: ALM-488<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nerve, Fluorescence, Surgery, Imaging, Real-time, Intraoperative, Highlighting