Fluorescent Probe VGT-309 to ID Cancerous Colorectal Lesions During Augmented Colonoscopy

Inclusion Criteria

1. Adult patients with histologically confirmed distal colorectal adenocarcinoma of anystage.

2. Be willing and able to sign the informed consent and comply with study procedures.

3. Are scheduled to undergo a SOC colonoscopy for restaging following radiochemotherapyor are scheduled to receive a SOC colonoscopy in the OR prior to resection

4. Have acceptable kidney and liver functions at study entry as evidenced by:

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

6. Creatinine clearance (according to Cockcroft-Gault Equation) > 50 mL/min

7. Total bilirubin < 1.5 times the upper limit of normal

8. Have an ECOG score of 0-2.

9. Be at least 18 years of age.

10. Female participants must be of non-childbearing potential, or, if of childbearingpotential be non-pregnant or lactating and agree to use highly effectivecontraception from screening through 30 days after probe infusion

11. Male participants, if not surgically sterilized, and if engaging in sexualintercourse with a female partner of childbearing potential, must be willing to usehighly effective contraception from screening through 30 days post-dose and agreenot to donate semen during this waiting period.

12. Highly effective contraception involves the use of a condom for the male, plus oneof the following for the female:

13. Oral, injectable, implantable, intravaginal, or transdermal hormonalcontraceptives, or

14. Intrauterine device or intrauterine hormone-releasing system. NOTE:Participants who abstain from heterosexual intercourse as their usual andpreferred lifestyle, will not be required to use contraception as describedabove. They are required to maintain abstinence from screening through Day 30,AND Participants in a same sex relationship, must use a barrier form ofcontraception (e.g., condom, diaphragm) to protect against the transfer of thestudy drug in any bodily fluids.

Exclusion Criteria:

Inclusion Criteria:

1. Adult patients with histologically confirmed distal colorectal adenocarcinoma of anystage.

2. Be willing and able to sign the informed consent and comply with study procedures.

3. Are scheduled to undergo a SOC colonoscopy for restaging following radiochemotherapyor are scheduled to receive a SOC colonoscopy in the OR prior to resection

4. Have acceptable kidney and liver functions at study entry as evidenced by:

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

6. Creatinine clearance (according to Cockcroft-Gault Equation) > 50 mL/min

7. Total bilirubin < 1.5 times the upper limit of normal

8. Have an ECOG score of 0-2.

9. Be at least 18 years of age.

10. Female participants must be of non-childbearing potential, or, if of childbearingpotential be non-pregnant or lactating and agree to use highly effectivecontraception from screening through 30 days after probe infusion

11. Male participants, if not surgically sterilized, and if engaging in sexualintercourse with a female partner of childbearing potential, must be willing to usehighly effective contraception from screening through 30 days post-dose and agreenot to donate semen during this waiting period.

12. Highly effective contraception involves the use of a condom for the male, plus oneof the following for the female:

13. Oral, injectable, implantable, intravaginal, or transdermal hormonalcontraceptives, or

14. Intrauterine device or intrauterine hormone-releasing system. NOTE:Participants who abstain from heterosexual intercourse as their usual andpreferred lifestyle, will not be required to use contraception as describedabove. They are required to maintain abstinence from screening through Day 30,AND Participants in a same sex relationship, must use a barrier form ofcontraception (e.g., condom, diaphragm) to protect against the transfer of thestudy drug in any bodily fluids.

Exclusion Criteria:

1. Pregnant or breastfeeding females

2. They have a known allergy or reaction to ICG, other radiographic contrast agents, orany component of VGT-309.

3. Have congenital long QT syndrome or QTcF > 450ms (males) or >470ms (females) byhistory or at Screening ECG.

4. They are prisoners, institutionalized individuals, or are unable to consent forthemselves.

5. Class 2 or higher obesity, defined by BMI ≥ 35.0.

6. Have any other comorbidity or habit that the Investigator believes will interferewith their ability to comply with and complete the study.