CompletedPhase 2NCT05400226

Phase 2 Study of VGT-309 in Lung Cancer

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.

Checked against the public recordLast updated Oct 17, 2024 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 2
U.S. locations1
SponsorVergent Bioscience, Inc.
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Vergent Bioscience, Inc.
Interventions being studied
Drug: VGT-309
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
03
Public criteria

Who may be able to participate

Inclusion Criteria: 1. Be willing and able to sign the informed consent and comply with study procedures. 2. Be between the ages of 18 and 85, inclusive. 3. Be male or female and meet the following conditions: 1. Female participants must be of non-childbearing potential, or, 2. If of childbearing potential be non-pregnant or non-lactating and agree to use highly effective contraception from screening through Day 30. 3. 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. 4. 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. 4. Have a lung nodule or mass that might be considered primary lung cancer or lung metastases, whether or not it is biopsy-proven. 5. 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. 6. Have acceptable kidney and liver functions at study entry as evidenced by: 1. Alanine Aminotransferase/Aspartate Aminotransferase (ALT/AST) \< 1.5 times the upper limit of normal 2. Serum creatinine \< 1.5 times the upper limit of normal 7. Have an Eastern Cooperative Oncology Group (ECOG) score of 0-2. 8. Meet all standard surgical and general anesthesia requirements. 9. Have not participated in a clinical trial within the last 30 days. Exclusion Criteria: 1. They are not a candidate for standard of care surgery based on opinion of the surgeon, anesthesiologist, or other consulting physician. 2. They have a known allergy or reaction to indocyanine green (ICG), other radiographic contrast agent, or any component of VGT-309. 3. Have congenital long QT syndrome or QTcF \> 450ms (males) or \>470ms (females) by history or at Screening ECG. 4. They are 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Hospital of the University of PennsylvaniaPhiladelphia, Pennsylvania

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 17, 2024. Always confirm current availability with the study team.

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