Status:
COMPLETED
Phase 2 Study of VGT-309 in Lung Cancer
Lead Sponsor:
Vergent Bioscience, Inc.
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
A Phase 2 open label study to evaluate safety and efficacy of VGT-309 to identify cancer in up to 40 subjects undergoing lung cancer surgery.
Detailed Description
A Phase 2, open-label study to evaluate the safety and efficacy of VGT-309, a tumor-targeted, activatable fluorescent imaging agent, to identify cancer in subjects undergoing lung cancer surgery. A to...
Eligibility Criteria
Inclusion
- Be willing and able to sign the informed consent and comply with study procedures.
- Be between the ages of 18 and 85, inclusive.
- Be male or female and 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.
- 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 post-dose 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: Participants 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.
- Have a lung nodule or mass that might be considered primary lung cancer or lung metastases, whether or not it is biopsy-proven.
- Be scheduled to undergo standard of care surgical resection for a lung nodule or mass with diagnostic and/or curative intent and meet all pre-operative surgical and anesthesia acceptance criteria.
- Have acceptable kidney and liver functions at study entry as evidenced by:
- Alanine Aminotransferase/Aspartate Aminotransferase (ALT/AST) \< 1.5 times the upper limit of normal
- Serum creatinine \< 1.5 times the upper limit of normal
- Have an Eastern Cooperative Oncology Group (ECOG) score of 0-2.
- Meet all standard surgical and general anesthesia requirements.
- Have not participated in a clinical trial within the last 30 days.
Exclusion
- They are not a candidate for standard of care surgery based on opinion of the surgeon, anesthesiologist, or other consulting physician.
- They have a known allergy or reaction to indocyanine green (ICG), other radiographic contrast agent, or any component of VGT-309.
- Have congenital long QT syndrome or QTcF \> 450ms (males) or \>470ms (females) by history or at Screening ECG.
- They are 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 :
May 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05400226
Start Date
May 24 2022
End Date
December 15 2023
Last Update
October 17 2024
Active Locations (1)
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1
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104