Colorectal Cancer
Conditions
Brief summary
The purpose of this study is to determine the safety and feasibility of VGT-309 for the visualization of colorectal tumors in real-time using near-infrared (NIR) fluorescence endoscopy. In addition, signatures of 50+ biomarkers will be evaluated in biopsies using CODEX multi-plexing.
Interventions
DRUGVGT-309
0.32mg/kg IV of VGT-309 given 12-36 hours before surgery
Sponsors
Stephan Rogalla
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult patients with histologically confirmed distal colorectal adenocarcinoma of any stage. 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 radiochemotherapy or 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: 1. ALT/AST \< 1.5 times the upper limit of normal, 2. Creatinine clearance (according to Cockcroft-Gault Equation) \> 50 mL/min 3. Total bilirubin \< 1.5 times the upper limit of normal 5. Have an ECOG score of 0-2. 6. Be at least 18 years of age. 7. Female participants must be of non-childbearing potential, or, if of childbearing potential be non-pregnant or lactating and agree to use highly effective contraception from screening through 30 days after probe infusion 8. 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. 9. Highly effective contraception involves the use of a condom for the male, plus one of the following for the female: 1. Oral, injectable, implantable, intravaginal, or transdermal hormonal contraceptives, or 2. 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, AND Participants in a same sex relationship, must use a barrier form of contraception (e.g., condom, diaphragm) to protect against the transfer of the study drug in any bodily fluids.
Exclusion criteria
Inclusion Criteria: 1. Adult patients with histologically confirmed distal colorectal adenocarcinoma of any stage. 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 radiochemotherapy or 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: 1. ALT/AST \< 1.5 times the upper limit of normal, 2. Creatinine clearance (according to Cockcroft-Gault Equation) \> 50 mL/min 3. Total bilirubin \< 1.5 times the upper limit of normal 5. Have an ECOG score of 0-2. 6. Be at least 18 years of age. 7. Female participants must be of non-childbearing potential, or, if of childbearing potential be non-pregnant or lactating and agree to use highly effective contraception from screening through 30 days after probe infusion 8. 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. 9. Highly effective contraception involves the use of a condom for the male, plus one of the following for the female: 1. Oral, injectable, implantable, intravaginal, or transdermal hormonal contraceptives, or 2. 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, AND Participants in a same sex relationship, must use a barrier form of contraception (e.g., condom, diaphragm) to protect against the transfer of the study drug in any bodily fluids.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Profile of VGT309 | 18 days | Safety profile will be measured by assessing number of Grade 2 or higher adverse events which have been determined to be clinically significant and definitely, probably or possibly related. |
| Feasibility of VGT-309 | 18 days | Feasibility to visualize colorectal tumors using NIR-endoscopy will be measured by the tumor-to-background ratio (fluorescence intensity of tumor tissue divided by the fluorescence intensity of normal surrounding tissue) and the concordance between white-light endoscopy assessment, histopathological examination and NIR imaging assessment. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORStephan Rogalla, M.D., PhD
Stanford University
Outcome results
None listed