Phase 2 Study of VGT-309 in Lung Cancer

Prior treatment

• They are not a candidate for standard of care surgery based on opinion of the surgeon, anesthesiologist, or other consulting physician.

Other illness

• They have a known allergy or reaction to indocyanine green (ICG), other radiographic contrast agent, or any component of VGT-309.

Lab values

• Have congenital long QT syndrome or QTcF \> 450ms (males) or \>470ms (females) by history or at Screening ECG.

Other

• 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.

• 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.