Phase 2B Safety and Efficacy Study of VGT-309 in Subjects With Cancer in the Lung.

NCT06145048 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: VGT-309-2B-2023
• Study Type: interventional
• Target: 89
• Locations: 2 countries
• Sites: 6

Brief Summary

This is a Phase 2, multi-center, open-label study to evaluate the safety and efficacy of VGT-309, a tumor-targeted, activatable fluorescent imaging agent, in subjects undergoing surgery for proven or suspected cancer in the lung. Approximately 100 subjects will be enrolled to ensure at least 86 subjects are evaluable with the option to expand enrollment by protocol amendment if deemed necessary by the DSC to meet primary and/or secondary objectives.

Conditions

Lung Cancer; Lung Metastases

Keywords

Lung Cancer; Metastatic Cancer in Lung

Outcome Measures

Primary Outcomes (1)

• Measurements taken under SOC surgical procedures and under NIR imaging

  Proportion of subjects with at least one Clinically Significant Event (CSE) defined as: A. Intraoperative localization of one or more preoperatively identified lung lesions using VGT-309 with NIR imaging B. Identification of one or more synchronous or occult lung lesions using VGT-309 with NIR imaging when standard surgical techniques using white light and palpation and preoperative imaging failed to identify the lesion(s C. Identification of fluorescence within ≤10 mm from the inside edge of the closest staple line as measured by the investigator ex vivo in the operating room using NIR imaging, with pathologic margin confirmed by histologic examination to be ≤ 10 mm. D. Identification of lymph nodes by VGT-309 with NIR imaging confirmed by histologic examination to be cancerous.

  During surgery and up to 1 month post-surgery

Secondary Outcomes (1)

• Measurements taken under SOC surgical procedures and under NIR imaging

  During surgery and up to one month post-surgery

Study Arms (1)

0.32 mg/kg VGT-309

EXPERIMENTAL

0.32 mg/kg VGT-309 given over 15-20 minutes by syringe pump

Drug: VGT-309

Interventions

VGT-309 DRUG

Intravenous drug to be given over 15-20 minutes by syringe pump.

0.32 mg/kg VGT-309

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be willing and able to sign the informed consent and comply with study procedures.
• Be at least 18 years of age.
• Meet the following conditions:
• Female participants must be of non-childbearing potential, or, If of childbearing potential, be non-pregnant or non-lactating and agree to use highly effective contraception from screening through Day 30 after treatment.
• 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 treatment and agree not to donate semen during this waiting period.
• Highly effective contraception involves the use of a condom for the male, plus one of the following for the female:
• Oral, injectable, implantable, intravaginal, or transdermal hormonal contraceptives, or Intrauterine device or intrauterine hormone-releasing system NOTE: Subjects who abstain from heterosexual intercourse as their usual and preferred lifestyle, will not be required to use contraception as described above. They are required to maintain abstinence from screening through Day 30 after treatment.
• Note: Subjects in a same sex relationship, must use a barrier form of contraception (e.g., condom, diaphragm) to protect against the transfer of the study drug in any bodily fluids.
• Have a lung nodule or mass that might be considered primary lung cancer or lung metastases whether or not it is biopsy-proven before surgery.
• Be scheduled to undergo standard of care surgical resection for a lung nodule or mass with diagnostic and/or curative intent
• Have acceptable kidney and liver functions at study entry as evidenced by:
• ALT/AST \< 1.5 times the upper limit of normal Calculated Creatinine Clearance (CrCl) ≥ 50 ml/min Total bilirubin \< 1.5 times the upper limit of normal Have an ECOG score of 0-2. Meet all standard of care surgical and general anesthesia requirements. 7) Have not participated in an interventional clinical trial within the last 30 days.

You may not qualify if:

• Not a candidate for standard of care surgery based on opinion of the surgeon, anesthesiologist, or other consulting physician.
• Have a known allergy or reaction to ICG, other radiographic contrast agent, or any component of VGT-309.
• Have congenital long QT syndrome or QTcF \> 470ms by history or at Screening ECG.
• Prisoners, institutionalized individuals, or are unable to consent for themselves.
• Have any other co-morbidity or habit that the Investigator believes will interfere with their ability to comply with and complete the study.

Sponsors & Collaborators

• Vergent Bioscience, Inc.: lead

Study Sites (6)

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

Orlando Health Cancer Institute

Orlando, Florida, 32806, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

St. Vincent's Hospital

Melbourne, Victoria, 3065, Australia

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Curtis Scribner, MD

  Vergent Bioscience

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an open label study in which all subjects will receive a dose of 0.32mg/kg VGT-309 (based on their weight) at 12-36 hours pre-surgery.

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 22, 2023
• Study Start: October 5, 2023
• Primary Completion: October 31, 2024
• Study Completion: February 20, 2025
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (5); AU (1)