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Bevonescein to Highlight Nerves in Patients Undergoing Head & Neck Surgery
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation/De-Escalation Cohorts | Experimental | This arm of the study will include Dose Escalation/De-Escalation cohorts of Bevonescein (ALM-488). |
|
| Dose Timing Cohorts | Experimental | This arm of the study will include Dose Timing cohorts of Bevonescein (ALM-488). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevonescein | Drug | Bevonescein Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 28 (+5) days |
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| Measure | Description | Time Frame |
|---|---|---|
| Time of Peak ALM-488 Concentration in Plasma (Cmax) | Time of peak ALM-488 concentration in plasma following intravenous ALM-488 infusion (hours). | 28 (+5) days |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego | San Diego | California | 92037 | United States | ||
| Stanford University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40595556 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose Defining Cohort 100mg | This group of the study will receive 100mg of Bevonescein (ALM-488). Bevonescein (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. 100mg of ALM-488 will be intravenously infused. |
| FG001 | Dose Defining Cohort 200mg | This group of the study will receive 200mg of ALM-488. 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. 200mg of ALM-488 will be intravenously infused. |
| FG002 | Dose Defining Cohort 400mg | This group of the study will receive 400mg of Bevonescein (ALM-488). Bevonescein (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. 400mg of ALM-488 will be intravenously infused. |
| FG003 | Dose Defining Cohort 500mg | This group of the study will receive 500mg of Bevonescein (ALM-488). Bevonescein (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. 500mg of ALM-488 will be intravenously infused. |
| FG004 | Dose Defining Cohort 600mg | This group of the study will receive 600mg of Bevonescein (ALM-488). Bevonescein (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. 600mg of ALM-488 will be intravenously infused. |
| FG005 | Dose Timing Cohort 3-5 Hours | This arm of the study will include patients infused wtih Bevonescein (ALM-488) at 500mg 3-5 hours prior to skin incision. Bevonescein (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. |
| FG006 | Dose Timing Cohort 1-3 Hours | This arm of the study will include patients infused wtih Bevonescein (ALM-488) at 500mg 1-3 hours prior to skin incision. Bevonescein (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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patients were accrued into the Dose Defining Cohorts (Dose Escalation/De-Escalation) and the Dose Timing Cohorts using the inclusion and exclusion criteria as defined in the protocol.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dose Defining 100mg | This arm of the study will include Dose Defining cohort at 100mg. 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 28 (+5) days |
|
28 (+5) days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dose Defining 100mg | This group of the study will receive 100mg of ALM-488. Bevonescein (ALM-488): ALM-488 Sterile Solution is an intravenously administered peptide-dye conjugate for nerve visualization during surgery. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| neck infection | Infections and infestations | MedDRA 23 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | MedDRA 23 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Alume Biosciences | 858-922-3966 | brett.berman@alumebiosciences.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 24, 2020 | Sep 23, 2022 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 25, 2021 | Sep 23, 2022 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D010307 | Parotid Neoplasms |
| D013964 | Thyroid Neoplasms |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D012468 | Salivary Gland Neoplasms |
| D009062 | Mouth Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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This is a Phase 1/Phase 2 study in patients undergoing Head & Neck Surgery.
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|
| Stanford |
| California |
| 94305 |
| United States |
| Harvard-Mass Eye & Ear | Boston | Massachusetts | 02114 | United States |
| Physician Decision |
|
| Dose Defining 200mg |
This arm of the study will include Dose Defining cohort at 200mg. 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. |
| BG002 | Dose Defining 400mg | This arm of the study will include Dose Defining cohort at 400mg. 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. |
| BG003 | Dose Defining 500mg | This arm of the study will include Dose Defining cohort at 500mg. 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. |
| BG004 | Dose Defining 600mg | This arm of the study will include Dose Defining cohort at 600mg. 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. |
| BG005 | Dose Timing 1-3hrs | This arm of the study will include Dose Timing cohorts of ALM-488 administration 1-3 hrs before surgery. 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. |
| BG006 | Dose Timing 3-5 Hrs | This arm of the study will include Dose Timing cohorts of ALM-488 administration 3-5 hrs before surgery. 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. |
| BG007 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Dose Defining 400mg | This arm of the study will include ALM-488 dose 400mg 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. |
| OG003 | Dose Defining 500mg | This arm of the study will include ALM-488 dose 500mg 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. |
| OG004 | Dose Defining 600mg | This arm of the study will include ALM-488 dose 600mg 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. |
| OG005 | Dose Timing 1-3hrs | This arm of the study will include ALM-488 timing of administration 1-3 hours before surgery. 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. |
| OG006 | Dose Timing 3-5 Hrs. | This arm of the study will include ALM-488 timing of administration 3-5 hours before surgery. 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. |
|
|
| Other Pre-specified | Time of Peak ALM-488 Concentration in Plasma (Cmax) | Time of peak ALM-488 concentration in plasma following intravenous ALM-488 infusion (hours). | Patients were accrued into the Dose Defining Cohorts (Dose Escalation/De-Escalation) and the Dose Timing Cohorts using inclusion and exclusion criteria as specified in the protocol. | Posted | Mean | Standard Deviation | hours | 28 (+5) days |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 2 |
| 3 |
| EG001 | Dose Defining 200mg | This group of the study will receive 200mg of ALM-488. Bevonescein (ALM-488): ALM-488 Sterile Solution is an intravenously administered peptide-dye conjugate for nerve visualization during surgery. | 0 | 3 | 0 | 3 | 1 | 3 |
| EG002 | Dose Defining 400mg | This group of the study will receive 400mg of ALM-488. Bevonescein (ALM-488): ALM-488 Sterile Solution is an intravenously administered peptide-dye conjugate for nerve visualization during surgery. | 0 | 3 | 0 | 3 | 1 | 3 |
| EG003 | Dose Defining 500mg | This group of the study will receive 500mg of ALM-488. Bevonescein (ALM-488): ALM-488 Sterile Solution is an intravenously administered peptide-dye conjugate for nerve visualization during surgery. | 0 | 3 | 0 | 3 | 0 | 3 |
| EG004 | Dose Defining 600mg | This group of the study will receive 600mg of ALM-488. Bevonescein (ALM-488): ALM-488 Sterile Solution is an intravenously administered peptide-dye conjugate for nerve visualization during surgery. | 0 | 3 | 1 | 3 | 2 | 3 |
| EG005 | Dose Timing 1-3hrs | This group of the study will receive ALM-488 1-3 hours before surgery. Bevonescein (ALM-488): ALM-488 Sterile Solution is an intravenously administered peptide-dye conjugate for nerve visualization during surgery.usly administered. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG006 | Dose Timing 3-5hrs | This group of the study will receive ALM-488 3-5 hours before surgery. Bevonescein (ALM-488): ALM-488 Sterile Solution is an intravenously administered peptide-dye conjugate for nerve visualization during surgery.usly administered. | 0 | 6 | 1 | 6 | 3 | 6 |
| Dental Infection | Infections and infestations | MedDRA 23 | Non-systematic Assessment |
|
| salivary gland fistula | Gastrointestinal disorders | MedDRA 23 | Non-systematic Assessment |
|
| chills | General disorders | MedDRA 23 | Non-systematic Assessment |
|
| non cardiac chest pain | General disorders | MedDRA 23 | Non-systematic Assessment |
|
| pain | General disorders | MedDRA 23 | Non-systematic Assessment |
|
| covid-19 | Infections and infestations | MedDRA 23 | Non-systematic Assessment |
|
| urinary tract infection | Infections and infestations | MedDRA 23 | Non-systematic Assessment |
|
| confusion | Injury, poisoning and procedural complications | MedDRA 23 | Non-systematic Assessment |
|
| nerve injury | Injury, poisoning and procedural complications | MedDRA 23 | Non-systematic Assessment |
|
| seroma | Injury, poisoning and procedural complications | MedDRA 23 | Non-systematic Assessment |
|
| pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23 | Non-systematic Assessment |
|
| facial paresis | Nervous system disorders | MedDRA 23 | Non-systematic Assessment |
|
| dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 23 | Non-systematic Assessment |
|
| dry skin | Skin and subcutaneous tissue disorders | MedDRA 23 | Non-systematic Assessment |
|
| abcess, neck | Infections and infestations | MedDRA 23 | Non-systematic Assessment |
|
| dizziness | Nervous system disorders | MedDRA 23 | Non-systematic Assessment |
|
| hypoaesthesia | Nervous system disorders | MedDRA 23 | Non-systematic Assessment |
|
| oral discomfort | Gastrointestinal disorders | MedDRA 23 | Non-systematic Assessment |
|
| retching | Gastrointestinal disorders | MedDRA 23 | Non-systematic Assessment |
|
| sialocele | Gastrointestinal disorders | MedDRA 23 | Non-systematic Assessment |
|
| asthenia | General disorders | MedDRA 23 | Non-systematic Assessment |
|
| localized edema | General disorders | MedDRA 23 | Non-systematic Assessment |
|
| facial asymmetry | Musculoskeletal and connective tissue disorders | MedDRA 23 | Non-systematic Assessment |
|
| musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 23 | Non-systematic Assessment |
|
| musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 23 | Non-systematic Assessment |
|
| incision site pain | Injury, poisoning and procedural complications | MedDRA 23 | Non-systematic Assessment |
|
| Paresis | Nervous system disorders | MedDRA 23 | Non-systematic Assessment |
|
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| D009059 |
| Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D010305 | Parotid Diseases |
| D012466 | Salivary Gland Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |