OncoMatch/Clinical Trials/NCT07463599
Safety and Efficacy of Tegavivint in Patients With Metastatic Colorectal Carcinoma
Is NCT07463599 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Tegavivint for metastatic colorectal carcinoma (mcrc).
Treatment: Tegavivint — This trial will evaluate the safety, tolerability, and preliminary efficacy of tegavivint as monotherapy (single) and in combination with standard therapies in patients with metastatic colorectal carcinoma (mCRC).
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Allowed: KRAS wild-type
if RAS wild-type, an anti-epidermal growth factor receptor (EGFR) therapy
Allowed: NRAS wild-type
if RAS wild-type, an anti-epidermal growth factor receptor (EGFR) therapy
Allowed: BRAF mutation
Patients with BRAF-mutant tumors must have been treated with a BRAF inhibitor
Allowed: APC mutation
Official conditions: Adenomatous Polyposis Coli (APC) Gene Mutation
Allowed: CTNNB1 mutation
Official conditions: Catenin Beta-1 (CTNNB1) Gene Mutation
Allowed: BRAF mutation
RAS, BRAF, and MSI/ dMMR (Mismatch repair deficiency) status for each patient must be documented
Allowed: MSH2 deficiency
MSI/ dMMR (Mismatch repair deficiency) status for each patient must be documented
Allowed: MSH6 deficiency
MSI/ dMMR (Mismatch repair deficiency) status for each patient must be documented
Allowed: MLH1 deficiency
MSI/ dMMR (Mismatch repair deficiency) status for each patient must be documented
Allowed: PMS2 deficiency
MSI/ dMMR (Mismatch repair deficiency) status for each patient must be documented
Disease stage
Metastatic disease required
metastatic colorectal adenocarcinoma; measurable disease as defined by RECIST 1.1
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: fluoropyrimidine-based chemotherapy — advanced/metastatic
fluoropyrimidine-, oxaliplatin- and irinotecan-based regimens
Must have received: oxaliplatin-based chemotherapy — advanced/metastatic
fluoropyrimidine-, oxaliplatin- and irinotecan-based regimens
Must have received: irinotecan-based chemotherapy — advanced/metastatic
fluoropyrimidine-, oxaliplatin- and irinotecan-based regimens
Must have received: anti-vascular endothelial growth factor (VEGF) therapy — advanced/metastatic
an anti-vascular endothelial growth factor (VEGF) therapy
Must have received: anti-epidermal growth factor receptor (EGFR) therapy — advanced/metastatic
if RAS wild-type, an anti-epidermal growth factor receptor (EGFR) therapy
Must have received: BRAF inhibitor — advanced/metastatic
Patients with BRAF-mutant tumors must have been treated with a BRAF inhibitor
Must have received: immune checkpoint inhibitor — advanced/metastatic
Patients with microsatellite-high or mismatch repair deficient tumors must have been treated with immune checkpoint inhibitors
Lab requirements
Blood counts
ANC ≥ 1.5 × 10^9/L; Platelets ≥ 100 × 10^9/L (no transfusion within 7 days prior); Hemoglobin ≥ 9 g/dL
Kidney function
Estimated creatinine clearance (CrCl) ≥ 50 mL/min or eGFR ≥ 50 mL/min/1.73m2 or measured creatinine clearance ≥ 50 mL/min
Liver function
Total bilirubin ≤ ULN; AST and ALT ≤ 2.5 × ULN or ≤ 5 × ULN if liver function abnormalities are due to underlying liver metastasis
Cardiac function
INR ≤ 1.5 × ULN unless on anticoagulant therapy; adequately controlled blood pressure (BP ≤ 150/90 mm Hg); Baseline QTc (Fridericia) < 450 ms; no NYHA > Class II heart failure; no uncontrolled hypertension; no unstable angina or arrhythmia; no myocardial infarct within 6 months; no clinically significant pericardial disease
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): ... see full criteria for details
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Clinical Trials Nurse Navigator · Scottsdale, Arizona
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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