Phase 2
N=27
Bevonescein to Highlight Nerves in Patients Undergoing Head & Neck Surgery
Parotid Neoplasm · Thyroid Neoplasms · Head and Neck Neoplasms · Surgery · Nerve Injury
Bottom Line
View on ClinicalTrials.gov: NCT04420689 ↗Enrolled (actual)
27
Serious AEs
7.4%
Results posted
May 2025
Primary outcome: Primary: Safety - The Number of Patients With ALM-488 Related Adverse Events — 0; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bevonescein (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alume Biosciences, Inc.
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety - The Number of Patients With ALM-488 Related Adverse Events |
0; 0; 0; 0; 0; 0 | — |
Summary
Bevonescein to Highlight Nerves in Patients Undergoing Head & Neck Surgery
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.
Data sourced from ClinicalTrials.gov (NCT04420689). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.