SurgeryPhase 2NCT06662097
A Study of Bevonescein in Patients Undergoing Abdominopelvic Surgery
A Phase 2 study testing Bevonescein in people with Surgery and Nerve Injury, run by Alume Biosciences, Inc. at 1 site in United States.
Trial summary
Feasibility study of Bevonescein to highlight Nerves and Ureter in patients undergoing Minimally Invasive Surgery Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgery, Nerve Injury, Imaging
- 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
- 1 siteUnited States
- Study dates
- 16 Oct 2024to 28 Jan 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be a minimum of 18 years of age
- Study participant is planning to proceed with surgery
- Willing to provide informed consent
- Sexually active patients must be willing to use an acceptable form of contraceptive while participating and 30 days after.
- Females of childbearing potential must have a negative pregnancy test at screening and during the study.
Who cannot join
- Patient has had prior surgery at the intended surgical site.
- Patient has abnormal cardiac rhythm not controlled by medication.
- Patient has moderate to severe renal impairment.
- Patient has a history of fluorescein allergy.
- Patient has a history of drug-related anaphylactic.
- Presence of a concurrent disease or condition that may interfere with study participation.
- Presence or history of any condition that, in the view of the investigator, places the patient at high risk of treatment compliance.
- Use of any Investigational Product or investigational medial device within 30 days prior to screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego
San Diego, California, 92037
About this study
Official title: Multicenter Open-Label Feasibility Study of Intraoperative Nerve and Ureter Visualization With Bevonescein in Patients Undergoing Minimally Invasive Abdominopelvic Surgery
Feasibility study of Bevonescein to highlight Nerves and Ureter in patients undergoing Minimally Invasive Surgery
Read the detailed description
This study will evaluate the safety, tolerability and efficacy of Bevonescein administered as an intravenous (IV) infusion to patients undergoing minimally invasive surgery. This study will also characterize the pharmacokinetic of Bevonescein in this subject population and determine the dose of Bevonescein needed to generate a fluorescence signal in nerve and ureter tissue to enable fluorescence recordings and image analysis with an imaging system.
- Conditions
- Surgery, Nerve Injury, Imaging
- Being tested
- Bevonescein
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 is a sterile solution that is intravenously administered
| Study group | Role | What they receive |
|---|---|---|
| Dose Defining | Experimental | A dose defining phase for each surgical setting. Receives: Drug: Bevonescein |
| Dose Expansion | Experimental | A dose expansion phase for each surgical setting. Receives: Drug: Bevonescein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluorescence System Survey
To assess the feasibility of the Fluorescence System in each of the identified Minimally Invasive Surgery settings, a Survey was utilized that includes 13 questions with a 1-5 Likert Scale response. A score of 1 is the least preferable and a score of 5 is the most preferable.
Measured: Day 1
Secondary outcomes (1)
To determine the optimal dose of Bevonescein in Minimally Invasive Surgery settings
The optimal dose for each of the identified surgical settings will be assessed by using three doses.
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.
- First posted28 Oct 2024
- Study start16 Oct 2024
- Primary completion2 Jan 2026
- Study completion28 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The study will begin with a dose-defining stage in each surgical setting. Once dose defining is complete, the study will proceed to a dose expansion phase for each surgical setting.
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alume Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662097
- Sponsor's protocol ID
- ALM-488-004
- Status last verified
- Oct 2026
- First submitted
- 25 Oct 2024
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Open-Label Feasibility Study of Intraoperative Nerve and Ureter Visualization With Bevonescein in Patients Undergoing Minimally Invasive Abdominopelvic Surgery
- ClinicalTrials.gov ID
- NCT06662097
- Acronym / sponsor ID
- ALM-488-004
- Conditions
- Surgery, Nerve Injury, Imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Alume Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Oct 2024 (actual)
- Primary completion
- 2 Jan 2026 (actual)
- Study completion
- 28 Jan 2026 (actual)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Feasibility study of Bevonescein to highlight Nerves and Ureter in patients undergoing Minimally Invasive Surgery
Detailed description
This study will evaluate the safety, tolerability and efficacy of Bevonescein administered as an intravenous (IV) infusion to patients undergoing minimally invasive surgery. This study will also characterize the pharmacokinetic of Bevonescein in this subject population and determine the dose of Bevonescein needed to generate a fluorescence signal in nerve and ureter tissue to enable fluorescence recordings and image analysis with an imaging system.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will begin with a dose-defining stage in each surgical setting. Once dose defining is complete, the study will proceed to a dose expansion phase for each surgical setting.
| Arm | Type | Receives |
|---|---|---|
| Dose Defining | Experimental | Drug: BevonesceinA dose defining phase for each surgical setting. |
| Dose Expansion | Experimental | Drug: BevonesceinA dose expansion phase for each surgical setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must be a minimum of 18 years of age
- Study participant is planning to proceed with surgery
- Willing to provide informed consent
- Sexually active patients must be willing to use an acceptable form of contraceptive while participating and 30 days after.
- Females of childbearing potential must have a negative pregnancy test at screening and during the study.
Key exclusion criteria (8 listed)
- Patient has had prior surgery at the intended surgical site.
- Patient has abnormal cardiac rhythm not controlled by medication.
- Patient has moderate to severe renal impairment.
- Patient has a history of fluorescein allergy.
- Patient has a history of drug-related anaphylactic.
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 is a sterile solution that is intravenously administered | Drug | Dose Defining, Dose Expansion |
Primary outcome
Fluorescence System Survey
Time frame: Day 1
To assess the feasibility of the Fluorescence System in each of the identified Minimally Invasive Surgery settings, a Survey was utilized that includes 13 questions with a 1-5 Likert Scale response. A score of 1 is the least preferable and a score of 5 is the most preferable.
1 secondary outcome
To determine the optimal dose of Bevonescein in Minimally Invasive Surgery settings
Time frame: 28 (+5 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevonescein in people with Surgery and Nerve Injury, run by Alume Biosciences, Inc. at 1 site 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 5 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 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Fluorescence System Survey (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2026.