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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-01204 | Registry Identifier | National Cancer Institute Clinical Trials Reporting Program |
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The drug supply expired and the sponsor is unable to provide an updated supply.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VGT-309 | Experimental | Subjects will receive an IV infusion of 0.32 mg/kg VGT-309 12 to 36 hours before a standard of care endoscopy procedure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VGT-309 | Drug | 0.32mg/kg IV of VGT-309 given 12-36 hours before surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety Profile of VGT309 | 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. | 18 days |
| Feasibility of VGT-309 | 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. | 18 days |
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Inclusion Criteria
Adult patients with histologically confirmed distal colorectal adenocarcinoma of any stage.
Be willing and able to sign the informed consent and comply with study procedures.
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
Have acceptable kidney and liver functions at study entry as evidenced by:
Have an ECOG score of 0-2.
Be at least 18 years of age.
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
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:
Exclusion Criteria:
Inclusion Criteria:
Adult patients with histologically confirmed distal colorectal adenocarcinoma of any stage.
Be willing and able to sign the informed consent and comply with study procedures.
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
Have acceptable kidney and liver functions at study entry as evidenced by:
Have an ECOG score of 0-2.
Be at least 18 years of age.
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
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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephan Rogalla, M.D., PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94304 | United States |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |