Bevonescein for Surgery

Overseen By Barbara Stephens

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Alume Biosciences, Inc.

Disqualifiers: Prior surgery, Cardiac rhythm, Renal impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

64 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Bevonescein (a peptide-dye conjugate) that enhances visibility of nerves and the ureter (the tube from kidney to bladder) during minimally invasive surgery. The researchers aim to determine the safe and effective dose of Bevonescein for patients. It suits individuals planning surgery who have not undergone surgery in the same area and do not have certain medical conditions, such as heart rhythm problems or kidney issues. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to medical advancements.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have an abnormal heart rhythm not controlled by medication, you may not be eligible to participate.

Is there any evidence suggesting that Bevonescein is likely to be safe for humans?

Research has shown that Bevonescein is generally safe for people. In earlier studies, participants received Bevonescein through an IV drip, and it proved to be safe. No harmful side effects required stopping the treatment, and no negative reactions occurred with the IV administration.

Additionally, Bevonescein did not cause any delays or cancellations of surgeries, indicating it does not interfere with surgical procedures. Early data suggest it may help surgeons see nerves more clearly during surgery, reducing the risk of nerve injury. Overall, the evidence suggests that Bevonescein is a safe option for patients undergoing minimally invasive surgery. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Bevonescein is unique because it may offer a new way to enhance surgical outcomes with its innovative dose-defining and dose-expansion phases. Unlike existing treatments that focus primarily on procedural techniques or standard medications, Bevonescein is designed to optimize drug delivery specifically for different surgical settings. Researchers are excited about this treatment because it could precisely tailor dosing to individual surgical needs, potentially improving recovery times and surgical success rates. This targeted approach distinguishes Bevonescein from the current one-size-fits-all methods, promising more personalized and effective surgical care.

What evidence suggests that Bevonescein is effective for highlighting nerves and ureter in minimally invasive surgery?

Research has shown that Bevonescein, which participants in this trial may receive, helps surgeons see nerves and ureters more clearly during surgery. It uses a special dye that illuminates these body parts, making them easier to locate. Studies have found that it can highlight damaged facial nerves, which are often difficult to detect. In early trials, Bevonescein proved safe and provided a strong glowing signal, assisting doctors during operations. This precision reduces the risk of accidental damage. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for patients who are about to have minimally invasive surgery in the abdominopelvic area. The study aims to include those who could benefit from better visualization of nerves and ureters during their procedure.

Inclusion Criteria

Willing to provide informed consent

I am planning to have surgery.

I agree to use birth control during and for 30 days after the trial.

Exclusion Criteria

Patient has a history of fluorescein allergy

Presence of a concurrent disease or condition that may interfere with study participation

Patient has a history of drug-related anaphylactic

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Defining

A dose defining phase for each surgical setting to determine the appropriate dose of Bevonescein

4 weeks

Dose Expansion

A dose expansion phase to further evaluate the safety, tolerability, and efficacy of Bevonescein

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bevonescein

Trial Overview The trial is testing Bevonescein, a substance used during surgery to make nerves and the ureter more visible. This may help surgeons avoid damaging these structures while operating.

How Is the Trial Designed?

Group I: Dose Expansion Experimental Treatment 1 Intervention

A dose expansion phase for each surgical setting.

Group II: Dose Defining Experimental Treatment 1 Intervention

A dose defining phase for each surgical setting.

Who Is Running the Clinical Trial?

Alume Biosciences, Inc.

Lead Sponsor

Trials

4

Recruited

390+

Published Research Related to This Trial

The use of a modified cyanoacrylate surgical glue (NBCA+MS) for occluding the great and small saphenous veins in 90 patients showed a high effectiveness, with complete occlusion maintained in 97.8% of patients after one year.

The procedure was safe, with no cases of post-surgical thrombosis or significant side effects, and allowed patients to return to normal activities within a week, highlighting its low invasiveness and minimal pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occlusion of the Great and Small Saphenous Vein Using Copolymeric Glue Based on N-Butyl Cyanoacrylate and Methacryloxy Sulfolane. Claudio, P., Pier Luca, BA., Miriam, F.[2023]

The study developed two peptide conjugates that effectively bind to the α(v)β(3) integrin, showing selective tumor targeting in U87MG tumor-bearing mice, which is crucial for cancer imaging and therapy.

The choice of linker between the peptide and the radiotracer significantly influenced the clearance rate from the bloodstream, while the peptides demonstrated metabolic stability, indicating potential for effective use in targeted cancer treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synthesis and in vivo evaluation of Tc-99m-labeled cyclic CisoDGRC peptide conjugates for targeting αvβ3 integrin expression. Pathuri, G., Sahoo, K., Awasthi, V., et al.[2019]

Glubran2, a cyanoacrylate glue, demonstrates superior adhesive properties and tensile strength compared to traditional fibrin glues, making it highly effective for bonding biological tissues in surgical and endoscopic procedures.

The study confirms that Glubran2 rapidly polymerizes upon contact with living tissues, creating a strong bond that is particularly beneficial in wet environments, enhancing its practical application in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glubran2 surgical glue: in vitro evaluation of adhesive and mechanical properties. Kull, S., Martinelli, I., Briganti, E., et al.[2014]

A new antibody-drug conjugate (ADC) using a stable tripeptide linker and a sulfur-bearing maytansinoid showed enhanced cytotoxicity and bystander killing effects in targeted cancer cells, indicating its potential as an effective treatment.

In vivo studies in mice demonstrated that these ADCs had improved efficacy compared to earlier maytansinoid conjugates, suggesting that the design of the linker and side chain can significantly influence therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peptide-Cleavable Self-immolative Maytansinoid Antibody-Drug Conjugates Designed To Provide Improved Bystander Killing. Costoplus, JA., Veale, KH., Qiu, Q., et al.[2020]

Inappropriate use of N-butyl-2-cyanoacrylate medical glue (MG) can lead to serious postoperative complications, as demonstrated in three cases involving abdominal pain, intestinal obstruction, and foreign body formation.

Careful evaluation of the indications, dosage, and application technique of MG is crucial to prevent complications, highlighting the need for awareness and reporting of such incidents in surgical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious postoperative complications induced by medical glue: three case reports. Li, W., Xiao, M., Chen, Y., et al.[2020]

The new light-activated surgical adhesives demonstrated significantly higher intraluminal bursting pressures (>300 mmHg) compared to traditional sutures (<150 mmHg), indicating superior strength and effectiveness in vascular tissue fusion.

Histological analysis revealed negligible thermal damage to surrounding tissues, suggesting that the laser-assisted adhesive method is safe and minimizes collateral damage, making it a promising alternative to conventional suturing techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved vascular tissue fusion using new light-activated surgical adhesive on a canine model. McNally, KM., Sorg, BS., Hammer, DX., et al.[2019]

Novel small peptide-dye conjugates were developed that effectively target over-expressed receptors on tumors, retaining both receptor affinity and dye fluorescence properties, which is advantageous for tumor imaging.

In vivo evaluations in rat tumor models demonstrated successful specific targeting of tumors using these peptide-dye conjugates, indicating their potential as effective optical contrast agents for tumor imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel fluorescent contrast agents for optical imaging of in vivo tumors based on a receptor-targeted dye-peptide conjugate platform. Bugaj, JE., Achilefu, S., Dorshow, RB., et al.[2019]

Human serum albumin (HSA) can be used to create targeted bionanoparticles by forming non-covalent complexes with near-infrared (NIR) dye-labeled peptides, which can enhance imaging for surgical guidance, particularly in identifying tumor-draining lymph nodes.

The study demonstrated the effectiveness of CXCR4-targeted bionanoparticles in vivo, showcasing their potential for use in sentinel lymph node procedures, leveraging the already clinically approved HSA scaffold for rapid clinical translation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted non-covalent self-assembled nanoparticles based on human serum albumin. Bunschoten, A., Buckle, T., Kuil, J., et al.[2021]

A pilot study using a proprietary cyanoacrylate (CA) for closing superficial veins in swine models showed that the treated veins were completely occluded 30 days after the procedure, with no signs of recanalization or migration.

Histological analysis indicated that the CA caused significant changes in the vein structure, suggesting that this method is effective for vein closure and warrants further investigation into its safety and effects on surrounding tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel vein closure procedure using a proprietary cyanoacrylate adhesive: 30-day swine model results. Min, RJ., Almeida, JI., McLean, DJ., et al.[2016]

Protein and peptide conjugates are crucial in medicine for enhancing the pharmacokinetics of therapeutic and diagnostic agents, allowing for better delivery and effectiveness.

Different types of conjugates—peptide, non-targeted protein, and targeted protein—serve specific purposes, such as improving imaging contrast, increasing the half-life of drugs, and enhancing delivery to specific sites like tumors or inflamed tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of protein and peptide conjugates. Bumbaca, B., Li, Z., Shah, DK.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12219357/

Intraoperative nerve-specific fluorescence visualization in ... The authors show in a Phase I multi-site trial that bevonescein was safe, established optimal dosing and timing, and provided a fluorescence signal for ...

2. journals.lww.com journals.lww.com/plasreconsurg/abstract/9900/intraoperative_real_time_fluorescence_labeling_of.2612.aspx

Intraoperative Real-Time Fluorescence Labeling of... This study demonstrates the utility of bevonescein, a fluorescein-conjugated nerve-binding peptide, in the identification of degenerated facial nerves.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04420689?spons=COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22Alume%20Biosciences,%20Inc.%22)&viewType=Table&rank=4

Study Details | NCT04420689 | Bevonescein to Highlight ... This study will evaluate the safety, tolerability, and efficacy of Bevonescein (ALM-488) administered as an intravenous (IV) infusion to patients undergoing ...

4. reporter.nih.gov reporter.nih.gov/project-details/10699258

Development of ALM-488 for nerve and ureter visualization ... Alume Biosciences has developed a novel peptide dye conjugate (ALM-488) that can be delivered intravenously before surgery as an agent to aid visualization of ...

5. news-medical.net news-medical.net/news/20250709/Fluorescent-guided-nerve-imaging-agent-shows-promise-for-use-in-humans.aspx

Fluorescent-guided nerve imaging agent shows promise ... A fluorescent-guided nerve imaging agent shows promise for use in humans, according to a paper published in Nature Communications.

6. nature.com nature.com/articles/s41467-025-60737-x

Intraoperative nerve-specific fluorescence visualization in ... Here, we present data of a nerve imaging agent showing that preoperative intravenous infusion of bevonescein is well tolerated.

7. firstwordpharma.com firstwordpharma.com/story/5977736

Alume Biosciences Announces Publication of Data ... Favorable Safety Profile: No dose-limiting toxicities or infusion reactions occurred. No surgeries were delayed or canceled due to the study ...

8. finance.yahoo.com finance.yahoo.com/news/alume-biosciences-announces-publication-data-165600301.html

Alume Biosciences Announces Publication of Data Examining ... "This first-in-human data demonstrate the safety of bevonescein and its potential to enhance nerve visualization in real time. ... "These data support our belief ...