Safety and Efficacy of Tegavivint in Patients With Metastatic Colorectal Carcinoma

Inclusion Criteria: 1. Signed informed consent form (ICF) 2. Male or female, 18 years of age or older 3. Histologically and/or cytologically documented metastatic colorectal adenocarcinoma (all other histological types are excluded) a. RAS, BRAF, and MSI/ dMMR (Mismatch repair deficiency) status for each patient must be documented. 4. Disease progression or intolerance to ≥ 2 lines of systemic therapy for advanced/metastatic disease, including the following prior therapies unless contraindicated: fluoropyrimidine-, oxaliplatin- and irinotecan-based regimens, an anti-vascular endothelial growth factor (VEGF) therapy, and if RAS wild-type, an anti-epidermal growth factor receptor (EGFR) therapy. 1. Prior treatment with trifluridine-tipiracil or fruquintinib is allowed 2. Patients with BRAF-mutant tumors must have been treated with a BRAF inhibitor 3. Patients with microsatellite-high or mismatch repair deficient tumors must have been treated with immune checkpoint inhibitors 5. Measurable disease as defined by RECIST 1.1. Lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, may be considered measurable if progression has been demonstrated in such lesions. 6. Willingness and ability to provide tumor biopsies during screening and while on treatment. On trial, biopsies considered low risk are required, moderate risk procedures are optional, and no high-risk procedures are allowed. 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 prior to the first dose of the investigational product(s) 8. Patients must have organ and marrow function as defined below during screening and performed by local laboratories within 7 days of the first dose of the investigational product(s): 1. Absolute neutrophil count (ANC) ≥ 1.5 × 109/L 2. Platelets ≥ 100 × 109/L; no transfusion within 7 days prior to the screening laboratory assessment 3. Hemoglobin ≥ 9 g/dL 4. Total bilirubin ≤ upper limit of normal (ULN) 5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN or ≤ 5 × ULN if liver function abnormalities are due to underlying liver metastasis 6. Renal function <!-- --> 1. Estimated creatinine clearance (CrCl) ≥ 50 mL/min by the Cockcroft-Gault equation using actual body weight, or 2. Estimated Glomerular Filtration Rate (eGFR) ≥ 50 mL/min/1.73m2 by Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) Creatinine Equation, or 3. Measured creatinine clearance ≥ 50 mL/min 4. Note: If estimated CrCl or eGFR is abnormal, accurate measurement may be obtained by 24-hour urine collection to measure creatinine clearance. g. International normalized ratio (INR) ≤ 1.5 × ULN, unless the patient is receiving anticoagulant therapy as long as the patient is within therapeutic range of intended use of anticoagulants h. Urine protein \<100mcg on urinalysis or 24-hour urine protein \< 2 grams 9. Washout or recovery period prior to Day 1 of Cycle 1: 1. At least 21 days from the last dose of prior systemic anticancer treatment 2. At least 14 days from palliative radiotherapy (≤ 10 fractions or ≤30 gray \[Gy\] total dose or at least 28 days from radiotherapy \> 30 Gy) to extrahepatic tumor lesions 3. At least 28 days from local or loco-regional therapy of intrahepatic tumor lesions (e.g., surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation) 4. At least 28 days from any major surgery and adequate wound healing has occurred. Major surgery is defined as any significantly invasive procedure into a major body cavity (abdomen, cranium etc.) and/or surgery requiring extensive recuperation (joint replacement). Please discuss with the medical monitor if there are any questions. 10. Grade ≤ 1 toxicity due to any previous cancer therapy according to the NCI-CTCAE v.5. Grade 2 is allowed in case of alopecia and/or peripheral sensory neuropathy. 11. Patients with past Hepatitis C virus (HCV) infection will be eligible for the trial. The treated patients must have completed their treatment at least 1 month prior to starting trial intervention and HCV viral load must be below the limit of quantification. 12. Patients with controlled Hepatitis B virus (HBV) will be eligible if they meet the following criteria: 1. Antiviral therapy for HBV must be given for at least 4 weeks, and HBV viral load must be less than 500 IU/mL prior to first dose of trial drug. Patients on active HBV therapy with viral loads under 100 IU/mL should stay on the same therapy throughout trial intervention. 2. Patients who are positive for anti-hepatitis B core antibody (HBcAb), negative for hepatitis B surface antigen (HBsAg), and negative or positive for anti-hepatitis B surface antibody (HBs), and who have an HBV viral load under 100 IU/mL, do not require HBV antiviral prophylaxis. 3. Patients must have adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤ 150/90 mm Hg at Screening and no change in antihypertensive medications within 1 week before Cycle 1 Day 1. Exclusion Criteria: 1. Patients receiving therapy with other anti-neoplastic or experimental agents. 2. Patients receiving concomitant strong or moderate inhibitors of CYP3A4/5 that cannot be discontinued 7 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1. 3. Patients receiving concomitant strong or moderate inducers of CYP3A4/5 that cannot be discontinued at least 14 days prior to Cycle 1 Day 1. 4. Patients with known history of Gilbert's syndrome or other genetic conditions affecting UGT1A1 function. 5. History of allergic reactions attributed to compounds of similar chemical or biologic composition to tegavivint, or other agents and excipients used in the trial including allergic reactions to Food, Drug, and Cosmetic (FD\&C) Yellow No. 5 (Tartrazine) or No. 6