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Tegavivint for Metastatic Colorectal Carcinoma

This study is testing a new drug called tegavivint for patients with metastatic colorectal carcinoma (mCRC), which is colorectal cancer that has spread to other parts of the body. Researchers want to see how safe tegavivint is, how well people tolerate it, and if it can help treat mCRC. Tegavivint works by interfering with a specific protein interaction in the body. The study will first test tegavivint on its own and then in combination with standard treatments. To join, you must be at least 18 years old and have documented metastatic colorectal adenocarcinoma. Your tumor's RAS, BRAF, and MSI/dMMR (Mismatch repair deficiency) status must also be known. The study aims to find the safest and most effective dose of tegavivint. The current status of this study is unclear, and it plans to enroll 126 participants.

Study design
This is a multi-part Phase 1/2 study that will test different doses of tegavivint, first alone and then in combination with standard treatments. It plans to enroll 126 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and tolerability will be measured for approximately 24 months.

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NCT07463599

Safety and Efficacy of Tegavivint in Patients With Metastatic Colorectal Carcinoma

Recruiting
PHASE1Ages 18+InterventionalTreatment
HonorHealth Research Institute
~126 participants
Updated 2026-03-11 on ClinicalTrials.gov
What's tested:Tegavivint

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Measured over ~24 months
+1 more outcome measured

Conditions

Metastatic Colorectal Carcinoma (mCRC)
Colorectal Cancer (CRC)
Adenomatous Polyposis Coli (APC) Gene Mutation
Catenin Beta-1 (CTNNB1) Gene Mutation

Explore related trials

Colorectal Carcinoma

Where it's being run

1 sites across 1 states
Arizona1

Who to contact

Clinical Trials Nurse Navigator
[email protected]
833-354-6667
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Congestive heart failure, New York Heart Association (NYHA) \> Class II
Uncontrolled hypertension (systolic blood pressure \>150 mmHg or diastolic pressure \> 90 mmHg despite optimal medical management)
Unstable angina pectoris or cardiac arrhythmia
Baseline QTc (Fridericia) ≥ 450 milliseconds. In the event a QTc (QT interval corrected Fridericia) measurement is not possible due to factors such as a pacemaker or bundle branch block, the patient may be evaluated by a cardiologist who must document no apparent increased risk for Torsades de Point or other morbidity associated with prolonged QTc. With such documentation, the patient may be eligible based with additional medical monitor review.
Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome
Myocardial infarct within 6 months before Cycle 1 Day 1
Clinically significant pericardial disease 14. Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for PK interactions. 15. Pregnant and breastfeeding women are excluded from this trial. The effects of tegavivint on the developing human fetus have the potential for teratogenic or abortifacient effects. There is an unknown but potential risk for Adverse Effects in nursing infants secondary to treatment of the mother with tegavivint. 16. Women of child-bearing potential (WOCBP) and men who are sexually active with WOCBP who do not agree to use one highly effective method of contraception, including hormonal contraceptives (e.g., combined oral contraceptives, patch, vaginal ring, injectables, and implants); intrauterine device or intrauterine system; vasectomy or tubal ligation; and one effective method of contraception, including male condom, female condom, cervical cap, diaphragm or contraceptive sponge or abstaining from sex for the duration of trial participation and for at least 6 months following completion of dosing (if applicable). Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this trial, she should inform her treating physician immediately. 17. Any other clinically significant disease or condition that, in the opinion of the investigator, may affect adherence to the protocol, or the signing of the ICF by the patient, or make participation in this clinical trial inappropriate.

What this trial measures

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]~24 months

    To establish the safety of tegavivint monotherapy treatment related toxicities as per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTC AE V5.0)

  • Maximum Tolerated Dose (MTD)/Administered Dose~24 months

    To determine the MTD and/or Recommended Phase 2 dose (RP2D) of tegavivint monotherapy. The dose escalation/de-escalation decisions will be made based on isotonic regression of dose-limiting toxicity (DLT) rates across all dose levels. The MTD will be selected as the dose with an estimated DLT probability closest to the target of 30% among the doses tested.