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

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ClinicalTrials.gov Identifier: NCT06145048
Recruitment Status : Recruiting
First Posted : November 22, 2023
Last Update Posted : January 24, 2024
Sponsor:
Information provided by (Responsible Party):
Vergent Bioscience, Inc.

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Lung Metastases Drug: VGT-309 Phase 2

Detailed Description:

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.

Following agreement with and signing of the informed consent, subjects will undergo screening measurements for the study within 4 weeks prior to the anticipated dosing:

  1. Medical, surgical and medication history.
  2. Complete physical exam, including vital signs and height
  3. Weight (needed for dose calculation)
  4. Chemistry, hematology, coagulation and urinalysis with microscopy clinical laboratory studies.
  5. 12-lead ECG.
  6. Serum pregnancy test for females of child-bearing potential.

After meeting all enrollment criteria, each subject will receive 0.32 mg/kg VGT-309 by IV administration 12-36 hours prior to surgery (refer to section VGT-309 Dosing, below). Subjects will be observed for 1 hour after dosing is completed and asked about possible treatment emergent adverse events.

Subjects will undergo surgical resection within 12-36 hours after completion of VGT-309 dosing. Measurements of efficacy will be taken during surgery and during the pathological examination of all surgical specimens. (Refer to Efficacy Endpoints and Efficacy Assessments sections).

Following surgery, subjects will be monitored for safety during their hospitalization. Between 7 to 14 and 25 to 35 days after surgery, the subjects will return to the clinic or have a telehealth visit for final safety assessments. At the last visit, if there are no adverse events requiring further follow up, subjects will then be released from the study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 Cancer in the Lung
Actual Study Start Date : October 5, 2023
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 0.32 mg/kg VGT-309
0.32 mg/kg VGT-309 given over 15-20 minutes by syringe pump
Drug: VGT-309
Intravenous drug to be given over 15-20 minutes by syringe pump.




Primary Outcome Measures :
  1. Measurements taken under SOC surgical procedures and under NIR imaging [ Time Frame: During surgery and up to 1 month post-surgery ]

    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.



Secondary Outcome Measures :
  1. Measurements taken under SOC surgical procedures and under NIR imaging [ Time Frame: During surgery and up to one month post-surgery ]

    Efficacy: To evaluate the sensitivity, positive predictive value (PPV), and 1-PPV of VGT-309 with NIR imaging for lesion(s) in vivo. Definitions to apply:

    1. Sensitivity is defined as the probability that the tissue fluoresces when it is cancer, as confirmed by histology (TP/(TP+FN)) *
    2. Positive predictive value (PPV) is defined as the probability that a tissue sample contains cancer on histologic exam if it fluoresces ((TP/(TP+FP))
    3. 1-Positive predictive value (1-PPV) is defined as the probability that a tissue sample does not contain cancer when it fluoresces ((FP/(TP+FP))* Where: * TP = true positive, FP = false positive, FN = false negative



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. 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.

  4. 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.
  5. Be scheduled to undergo standard of care surgical resection for a lung nodule or mass with diagnostic and/or curative intent
  6. 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.

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Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06145048


Contacts
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Contact: Maggie M Neptune, B.S. 510-410-9124 mneptune@vergentbio.com
Contact: Eric Bensen, Ph.D. 952-479-7496 ebensen@vergentbio.com

Locations
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United States, Florida
Orlando Health Cancer Institute Recruiting
Orlando, Florida, United States, 32806
Contact: Bridey L Casillas, LPN    321-841-8284    Bridey.Casillas@orlandohealth.com   
Contact: Stephanie A Ribacchi    321-841-1077    Stephanie.Ribacchi@orlandohealth.com   
Principal Investigator: Luis J Herrera, MD         
United States, Minnesota
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Bobbie Skarre, R.N.    507-293-0807    Skarre.Bobbie@mayo.edu   
Contact: Karly Pierson, R.N.    507-538-1960    Pierson.Karlyn@mayo.edu   
Principal Investigator: Janani Reisenauer, M.D.         
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Margaux Mazur, MPH    215-614-0615    margaux.mazur@pennmedicine.upenn.edu   
Principal Investigator: Sunil Singhal, MD         
United States, Texas
University of Texas MD Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
Contact: Craig DeGraaf, R.N.    713-563-9155    cedegra@mdanderson.org   
Contact: Sandy Rivera, R.N.    713-563-9156    saRivera@mdanderson.org   
Principal Investigator: David Rice, M.D.         
Australia, Victoria
St. Vincent's Hospital Not yet recruiting
Melbourne, Victoria, Australia, 3065
Principal Investigator: Gavin Wright, MBBS, FRACS         
Sponsors and Collaborators
Vergent Bioscience, Inc.
Investigators
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Study Director: Curtis Scribner, MD Vergent Bioscience
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Responsible Party: Vergent Bioscience, Inc.
ClinicalTrials.gov Identifier: NCT06145048    
Other Study ID Numbers: VGT-309-2B-2023
First Posted: November 22, 2023    Key Record Dates
Last Update Posted: January 24, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The joint publication will be coordinated by Vergent. There is no need for individual sites to review specific IPD from other sites.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vergent Bioscience, Inc.:
Lung Cancer
Metastatic Cancer in Lung
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases