Trial Title:
Phase 2B Safety and Efficacy Study of VGT-309 in Subjects With Cancer in the Lung.
NCT ID:
NCT06145048
Condition:
Lung Cancer
Lung Metastases
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
Lung Cancer
Metastatic Cancer in Lung
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
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.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
VGT-309
Description:
Intravenous drug to be given over 15-20 minutes by syringe pump.
Arm group label:
0.32 mg/kg VGT-309
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.
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.
Criteria for eligibility:
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.
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope National Medical Center
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Dia Parungao, RN
Email:
DL-LungCRN@coh.org
Investigator:
Last name:
Jae Kim, MD
Email:
Principal Investigator
Facility:
Name:
Orlando Health Cancer Institute
Address:
City:
Orlando
Zip:
32806
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bridey L Casillas, LPN
Phone:
321-841-8284
Email:
Bridey.Casillas@orlandohealth.com
Contact backup:
Last name:
Stephanie A Ribacchi
Phone:
321-841-1077
Email:
Stephanie.Ribacchi@orlandohealth.com
Investigator:
Last name:
Luis J Herrera, MD
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bobbie Skarre, R.N.
Phone:
507-293-0807
Email:
Skarre.Bobbie@mayo.edu
Contact backup:
Last name:
Karly Pierson, R.N.
Phone:
507-538-1960
Email:
Pierson.Karlyn@mayo.edu
Investigator:
Last name:
Janani Reisenauer, M.D.
Email:
Principal Investigator
Facility:
Name:
Hospital of the University of Pennsylvania
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Margaux Mazur, MPH
Phone:
215-614-0615
Email:
margaux.mazur@pennmedicine.upenn.edu
Investigator:
Last name:
Sunil Singhal, MD
Email:
Principal Investigator
Facility:
Name:
University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Craig DeGraaf, R.N.
Phone:
713-563-9155
Email:
cedegra@mdanderson.org
Contact backup:
Last name:
Sandy Rivera, R.N.
Phone:
713-563-9156
Email:
saRivera@mdanderson.org
Investigator:
Last name:
David Rice, M.D.
Email:
Principal Investigator
Facility:
Name:
St. Vincent's Hospital
Address:
City:
Melbourne
Zip:
3065
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Jane M Mack, RN, BA
Phone:
+613.9231.1618
Email:
jane.mack@svha.org.au
Contact backup:
Last name:
Jacinda Lien, RN, M.NSc
Phone:
+61.422.900883
Email:
jacinda.lein@svha.org.au
Investigator:
Last name:
Gavin Wright, MBBS, FRACS
Email:
Principal Investigator
Start date:
October 5, 2023
Completion date:
August 2024
Lead sponsor:
Agency:
Vergent Bioscience, Inc.
Agency class:
Industry
Source:
Vergent Bioscience, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06145048
