Status:
COMPLETED
Phase 2B Safety and Efficacy Study of VGT-309 in Subjects With Cancer in the Lung.
Lead Sponsor:
Vergent Bioscience, Inc.
Conditions:
Lung Cancer
Lung Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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.
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Exclusion
- 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.
Key Trial Info
Start Date :
October 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2025
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT06145048
Start Date
October 5 2023
End Date
February 20 2025
Last Update
March 28 2025
Active Locations (6)
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1
City of Hope National Medical Center
Duarte, California, United States, 91010
2
Orlando Health Cancer Institute
Orlando, Florida, United States, 32806
3
Mayo Clinic
Rochester, Minnesota, United States, 55905
4
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104