A Study of Bevonescein in Patients Undergoing Abdominopelvic Surgery

Alume Biosciences

Status and phase: Enrolling; Phase 2

Conditions: Imaging; Surgery; Nerve Injury

Treatments: Drug: Bevonescein

Study type: Interventional

Funder types: Industry

Identifiers

NCT06662097

ALM-488-004

Details and patient eligibility

About

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

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Dose Defining

Experimental group

Description:

A dose defining phase for each surgical setting.

Treatment:

Drug: Bevonescein

Dose Expansion

Experimental group

Description:

A dose expansion phase for each surgical setting.

Treatment:

Drug: Bevonescein