Recruiting
Phase 3

Abenacianine

Sponsor:

Vergent Bioscience, Inc.

Code:

NCT07499674

Conditions

Lung Cancer

Lung Metastases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Abenacianine

Near Infrared (NIR) Imaging

Study Details

Brief summary:

This is a Phase 3, multi-center, randomized and intrasubject controlled study to evaluate the safety and efficacy of abenacianine for injection, a tumor-targeted, activatable fluorescent imaging agent, to identify cancer using NIR imaging in participants undergoing surgery for cancer in the lung. Approximately 132 partiipants will be enrolled to ensure a minimum of 115 evaluable participants receiving abenacianine and undergoing NIR imaging and a control group of 12 participants who will receive abenacianine but no NIR imaging.

Conditions

Lung Cancer

Lung Metastases

Study ID

NCT07499674

Start date

Mar 31, 2026

Status verified date

Aug, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Be willing and able to sign the informed consent and comply with study procedures.
2. Be at least 18 years of age.
3. Be scheduled for or planning to have a surgical resection of a lung lesion or mass with diagnostic and/or curative intent.
4. Meet all requirements for the planned surgery based on opinion of the surgeon, anesthesiologist, and/or other consulting physician.
5. Be able to meet the following conditions:

1. Female participants must be of non-childbearing potential, or,
2. If of childbearing potential, be non-pregnant or non-lactating and agree to use highly effective contraception from screening through Day 30 after treatment.
3. Male participants, if not surgically sterilized, and if engaging in sexual intercourse with a female partner of childbearing potential, must be willing to use highly effective contraception from screening through 30 days after dosing.
6. Have not participated in an interventional clinical trial within the last 30 days.

Exclusion Criteria:

1. They have a known allergy or reaction to radiographic contrast agents, ICG, or any component of abenacianine.
2. They have received chemotherapy, immunotherapy or radiotherapy within 4 weeks prior to study enrollment.
3. They have any other co-morbidity or habit that the Investigator believes will interfere with their ability to comply with and complete the study. They are not a candidate for standard of care surgery based on opinion of the surgeon, anesthesiologist, or other consulting physician.
4. They are prisoners, institutionalized individuals, or are unable to consent for themselves.

Study Design

Enrollment

132 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Abenacianine with surgery using Standard of Care (SOC) only

Participants randomized to this arm will receive abenacianine 0.31mg/kg 12-96 hours before undergoing surgery using SOC only.

other: Abenacianine with surgery using Standard of Care plus Near infrared (NIR) imaging

Participants randomized to this arm will receive abenacianine 0.31mg/kg 12-96 hours before undergoing surgery using SOC plus NIR imaging.

Interventions

Abenacianine

Intravenous drug to be given by syringe pump.

Near Infrared (NIR) Imaging

NIR imaging is a non-visible, optical technique capturing light just beyond human vision, allowing high-contrast imaging.

Primary outcome measure

  • Identify the proportion of participants with at least one Clinically Significant Event (CSE) as defined by: [ Time Frame: Day of Surgery ]

Central Contacts and Locations

Locations

City of Hope National Medical Center

Recruiting

Duarte, California, United States, 91010

University of Colorado Hospital

Recruiting

Aurora, Colorado, United States, 80045

Orlando Health Cancer Center

Recruiting

Orlando, Florida, United States, 32806

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

University of Texas, MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Vergent Bioscience, Inc.

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • Lung Cancer
  • Metastatic Cancer in Lung

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Vergent Bioscience, Inc. on 2026-08-19.