A Study of Bevonescein in Patients Undergoing Abdominopelvic Surgery

Phase 2

Recruiting

• Conditions: Surgery; Nerve Injury; Imaging
• Interventions: Drug: Bevonescein

• Registration Number: NCT06662097
• Lead Sponsor: Alume Biosciences, Inc.

Brief Summary

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 Timeline

• Status Verified: 2024-10
• Study Start: 2024-10-16
• Study First Submitted: 2024-10-25
• Study First Submitted QC: 2024-10-25
• Last Update Submitted: 2024-10-25
• Study First Posted: 2024-10-28
• Last Update Posted: 2024-10-28
• Primary Completion: 2025-06
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose Defining	Bevonescein	A dose defining phase for each surgical setting.
Dose Expansion	Bevonescein	A dose expansion phase for each surgical setting.

Primary Outcome Measures

Name	Time	Method
Fluorescence System Survey	28 (+5 days)	To assess the feasibility of the Fluorescence System in each of the identified Minimally Invasive Surgery settings.

Secondary Outcome Measures

Name	Time	Method
To determine the optimal dose of Bevonescein in Minimally Invasive Surgery settings	28 (+5 days)	The optimal dose for each of the identified surgical settings will be assessed by using three doses.

Trial Locations

Locations (1)

University of California San Diego; 🇺🇸 San Diego, California, United States