Clinical trial · Interventional
Bevonescein to Highlight Nerves in Patients Undergoing Head & Neck Surgery
Phase 1/2 Trial of ALM-488 in Patients Undergoing Head & Neck Surgery
NCT04420689CI-TRIAL-00089443completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Bevonescein to Highlight Nerves in Patients Undergoing Head \& Neck Surgery
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Imaging | — | UNRESOLVED | — |
| Nerve Injury | — | UNRESOLVED | — |
| Parotid Neoplasm | Parotid Gland Neoplasm | ALIAS | 0.90 |
| Surgery | — | UNRESOLVED | — |
| Thyroid Neoplasms | Thyroid Gland Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevonescein | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose Escalation/De-Escalation Cohorts
- description
- This arm of the study will include Dose Escalation/De-Escalation cohorts of Bevonescein (ALM-488).
- interventionNames
- Drug: Bevonescein
- type
- EXPERIMENTAL
- label
- Dose Timing Cohorts
- description
- This arm of the study will include Dose Timing cohorts of Bevonescein (ALM-488).
- interventionNames
- Drug: Bevonescein
Primary outcomes (1)
- measure
- Safety - The Number of Patients With ALM-488 Related Adverse Events
- timeFrame
- 28 (+5) days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDLee 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. PMID 40595556