A Study of Bevonescein in Patients Undergoing Abdominopelvic Surgery

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

Study Overview

• Status: Recruiting
• Conditions: Surgery; Nerve Injury; Imaging
• Intervention / Treatment: Drug: Bevonescein

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 Type: Interventional
• Enrollment (Estimated): 64
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Barbara Stephens; Phone Number: 6145569561; Email: barbara.stephens@alumebiosciences.com

Study Locations

• United States
  • California
    • San Diego, California, United States, 92037
      • Recruiting
      • University of California San Diego
      • Contact: Principal Investigator

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Defining; A dose defining phase for each surgical setting.	Drug: Bevonescein; Bevonescein is a sterile solution that is intravenously administered; Other Names: ALM-488
Experimental: Dose Expansion; A dose expansion phase for each surgical setting.	Drug: Bevonescein; Bevonescein is a sterile solution that is intravenously administered; Other Names: ALM-488

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluorescence System Survey	To assess the feasibility of the Fluorescence System in each of the identified Minimally Invasive Surgery settings.	28 (+5 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	28 (+5 days)

Collaborators and Investigators

• Sponsor: Alume Biosciences, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: October 25, 2024
• First Submitted That Met QC Criteria: October 25, 2024
• First Posted (Actual): October 28, 2024

Study Record Updates

• Last Update Posted (Actual): October 28, 2024
• Last Update Submitted That Met QC Criteria: October 25, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: ALM-488-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No