A Study of Bevonescein in Patients Undergoing Abdominopelvic Surgery

NCT06662097 | Recruiting Phase 2 FDA Drug

• 1 other identifier: ALM-488-004
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Feasibility study of Bevonescein to highlight Nerves and Ureter in patients undergoing Minimally Invasive Surgery

Conditions

Surgery; Nerve Injury; Imaging

Outcome Measures

Primary Outcomes (1)

• Fluorescence System Survey

  To assess the feasibility of the Fluorescence System in each of the identified Minimally Invasive Surgery settings.

  28 (+5 days)

Secondary Outcomes (1)

• To determine the optimal dose of Bevonescein in Minimally Invasive Surgery settings

  28 (+5 days)

Study Arms (2)

Dose Defining

EXPERIMENTAL

A dose defining phase for each surgical setting.

Drug: Bevonescein

Dose Expansion

EXPERIMENTAL

A dose expansion phase for each surgical setting.

Drug: Bevonescein

Interventions

Bevonescein DRUG

Bevonescein is a sterile solution that is intravenously administered

Also known as: ALM-488

Dose Defining; Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alume Biosciences, Inc.: lead

Study Sites (1)

University of California San Diego

San Diego, California, 92037, United States

RECRUITING

Central Study Contacts

Barbara Stephens

CONTACT

6145569561; barbara.stephens@alumebiosciences.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 28, 2024
• Study Start: October 16, 2024
• Primary Completion: June 1, 2025
• Study Completion: September 1, 2025
• Last Updated: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)