Parotid NeoplasmPhase 1/2NCT04420689

Bevonescein to Highlight Nerves in Patients Undergoing Head & Neck Surgery

A Phase 1/2 study testing Bevonescein in people with Parotid Neoplasm and Thyroid Neoplasms, run by Alume Biosciences, Inc. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Bevonescein to Highlight Nerves in Patients Undergoing Head \& Neck Surgery Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Parotid Neoplasm, Thyroid Neoplasms, Head and Neck Neoplasms
What is being tested?: Bevonescein
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 3 sitesUnited States
Study dates: 18 Jun 2020to 15 Feb 2022
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Harvard-Mass Eye & Ear
Boston, Massachusetts, 02114
University of California San Diego
San Diego, California, 92037
Stanford University
Stanford, California, 94305

Other trials in United States

About this study

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

Bevonescein to Highlight Nerves in Patients Undergoing Head \& Neck Surgery

Read the detailed 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.

Conditions: Parotid Neoplasm, Thyroid Neoplasms, Head and Neck Neoplasms, Surgery, Nerve Injury, Imaging
Being tested: Bevonescein
Keywords: Nerve, Fluorescence, Surgery, Imaging, Real-time, Intraoperative, Highlighting
Medical subject headings: Parotid Neoplasms, Thyroid Neoplasms, Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04420689
Study group	Role	What they receive
Dose Escalation/De-Escalation Cohorts	Experimental	This arm of the study will include Dose Escalation/De-Escalation cohorts of Bevonescein (ALM-488). Receives: Drug: Bevonescein
Dose Timing Cohorts	Experimental	This arm of the study will include Dose Timing cohorts of Bevonescein (ALM-488). Receives: Drug: Bevonescein

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety - The Number of Patients With ALM-488 Related Adverse Events
The number of patients with ALM-488 related Adverse Events according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Measured: 28 (+5) days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Jun 202015 Feb 2022

First posted9 Jun 2020
Study start18 Jun 2020
Primary completion25 Jun 2021
Study completion15 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Parotid NeoplasmStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Sequential
Model description: This is a Phase 1/Phase 2 study in patients undergoing Head \& Neck Surgery.
Masking: None (open label)
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04420689
Sponsor's protocol ID: ALM-488-001
Status last verified: Apr 2025
First submitted: 3 Jun 2020
Last updated: 8 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Lee YJ, Orosco RK, Bouvet M, Richmon JD, Berman BJ, Crawford KL, Hom M, Nguyen QT, Rosenthal EL. Intraoperative nerve-specific fluorescence visualization in head and neck surgery: a Phase 1 trial. Nat Commun. 2025 Jul 2;16(1):6060. doi: 10.1038/s41467-025-60737-x.
PubMed 40595556

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Sparing Parotid Ducts Via MRI Sialography for Reduced Patient-Reported Xerostomia
Head and Neck Cancer
Active, not recruitingPhase 2
Customized 3D Printed Oral Stents During Head and Neck Radiotherapy
Head and Neck Carcinoma, Malignant Parotid Gland Neoplasm
RecruitingEarly Phase 1
Clinical Tolerance of an Intraparotid Injection of Bupivacaine, Combined With Dexamethasone, After Parotidectomy for Benign Tumor
Parotid Neoplasm, Bupivacaine
Active, not recruitingPhase 2
A Study of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia
Grade 2 and 3 Late Xerostomia Caused by Radiotherapy for Cancers of the Upper Aerodigestive Tract, Excluding the Parotid Glands
Recruiting
Swedish National Parotidectomy Study (SNaPs): Drainless Versus Standard Surgery
Parotid Neoplasms, Post-operative Complications

All Parotid Neoplasm trials

Study at a glance

From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1/2 Trial of ALM-488 in Patients Undergoing Head & Neck Surgery
ClinicalTrials.gov ID: NCT04420689
Acronym / sponsor ID: ALM-488-001
Conditions: Parotid Neoplasm, Thyroid Neoplasms, Head and Neck Neoplasms, Surgery, Nerve Injury, Imaging
Keywords: Nerve, Fluorescence, Surgery, Imaging, Real-time, Intraoperative, Highlighting
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Alume Biosciences, Inc.Industry (pharma, biotech, devices)
Study start: 18 Jun 2020 (actual)
Primary completion: 25 Jun 2021 (actual)
Study completion: 15 Feb 2022 (actual)
First posted: 9 Jun 2020 (actual)
Results: Posted 8 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Bevonescein to Highlight Nerves in Patients Undergoing Head \& Neck Surgery

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2
Model description: This is a Phase 1/Phase 2 study in patients undergoing Head \& Neck Surgery.

Arm	Type	Receives
Dose Escalation/De-Escalation Cohorts	Experimental	Drug: BevonesceinThis arm of the study will include Dose Escalation/De-Escalation cohorts of Bevonescein (ALM-488).
Dose Timing Cohorts	Experimental	Drug: BevonesceinThis arm of the study will include Dose Timing cohorts of Bevonescein (ALM-488).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BevonesceinAlso: ALM-488Bevonescein Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue.	Drug	Dose Escalation/De-Escalation Cohorts, Dose Timing Cohorts

Primary outcome

Safety - The Number of Patients With ALM-488 Related Adverse Events
Time frame: 28 (+5) days
The number of patients with ALM-488 related Adverse Events according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

Results and safety

Results posted to the registry on 8 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dose Defining Cohort 100mg	3	3
Dose Defining Cohort 200mg	3	3
Dose Defining Cohort 400mg	3	3
Dose Defining Cohort 500mg	3	3
Dose Defining Cohort 600mg	3	2
Dose Timing Cohort 3-5 Hours	6	5
Dose Timing Cohort 1-3 Hours	6	6

Primary outcome: Safety - The Number of Patients With ALM-488 Related Adverse Events

Time frame: 28 (+5) days. Count of participants. Unit: Participants

Measure	Dose Defining 100mg n = 3	Dose Defining 200mg n = 3	Dose Defining 400mg n = 3	Dose Defining 500mg n = 3	Dose Defining 600mg n = 3	Dose Timing 1-3hrs n = 6	Dose Timing 3-5 Hrs. n = 6
Value	0	0	0	0	0	0	0

Adverse events

Time frame: 28 (+5) days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dose Defining 100mg	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3
Dose Defining 200mg	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
Dose Defining 400mg	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
Dose Defining 500mg	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Dose Defining 600mg	1 of 3 (33.3%)	2 of 3 (66.7%)	0 of 3
Dose Timing 1-3hrs	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Dose Timing 3-5hrs	1 of 6 (16.7%)	3 of 6 (50%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40595556Lee YJ, Orosco RK, Bouvet M, Richmon JD, Berman BJ, Crawford KL, Hom M, Nguyen QT, Rosenthal EL. Intraoperative nerve-specific fluorescence visualization in head and neck surgery: a Phase 1 trial. Nat Commun. 2025 Jul 2;16(1):6060. doi: 10.1038/s41467-025-60737-x.
Individual participant dataSharing planned: No

Related trials for Parotid Neoplasm

RecruitingPhase 2
Sparing Parotid Ducts Via MRI Sialography for Reduced Patient-Reported Xerostomia
Head and Neck Cancer
Active, not recruitingPhase 2
Customized 3D Printed Oral Stents During Head and Neck Radiotherapy
Head and Neck Carcinoma, Malignant Parotid Gland Neoplasm
RecruitingEarly Phase 1
Clinical Tolerance of an Intraparotid Injection of Bupivacaine, Combined With Dexamethasone, After Parotidectomy for Benign Tumor
Parotid Neoplasm, Bupivacaine
Active, not recruitingPhase 2
A Study of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia
Grade 2 and 3 Late Xerostomia Caused by Radiotherapy for Cancers of the Upper Aerodigestive Tract, Excluding the Parotid Glands
Recruiting
Swedish National Parotidectomy Study (SNaPs): Drainless Versus Standard Surgery
Parotid Neoplasms, Post-operative Complications

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Bevonescein in people with Parotid Neoplasm and Thyroid Neoplasms, run by Alume Biosciences, Inc. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety - The Number of Patients With ALM-488 Related Adverse Events (time frame: 28 (+5) days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04420689, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.