Phase 2 Study of VGT-309 in Lung Cancer

• Status: Recruiting
• Trial end date: 2022-11-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vergent Bioscience, Inc.

Criteria

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 biopsyproven.

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. ALT/AST < 1.5 times the upper limit of normal

2. Serum creatinine < 1.5 times the upper limit of normal

7. Have an 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 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.