Safety and Efficacy of Tegavivint in Patients With Metastatic Colorectal Carcinoma (NCT07463599) | Clinical Trial Compass
RecruitingPhase 1/2
Safety and Efficacy of Tegavivint in Patients With Metastatic Colorectal Carcinoma
United States126 participantsStarted 2026-02-17
Plain-language summary
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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signed informed consent form (ICF)
. Male or female, 18 years of age or older
. Histologically and/or cytologically documented metastatic colorectal adenocarcinoma (all other histological types are excluded)
. 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.
. Prior treatment with trifluridine-tipiracil or fruquintinib is allowed
. Patients with BRAF-mutant tumors must have been treated with a BRAF inhibitor
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
. Patients with microsatellite-high or mismatch repair deficient tumors must have been treated with immune checkpoint inhibitors
. 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.
Exclusion criteria
. Patients receiving therapy with other anti-neoplastic or experimental agents.
. 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.
. Patients receiving concomitant strong or moderate inducers of CYP3A4/5 that cannot be discontinued at least 14 days prior to Cycle 1 Day 1.
. Patients with known history of Gilbert's syndrome or other genetic conditions affecting UGT1A1 function.
. 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 (Sunset Yellow FCF).
. Malignant disease, other than that being treated in this trial. Note: Patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) who have undergone potentially curative therapy are not excluded. Other exceptions include malignancies that were treated curatively and have not recurred within 3 years prior to Cycle 1 Day 1 and any malignancy considered indolent and that has never required therapy.
. Lack of peripheral venous or central venous access or any condition that would interfere with drug administration or collection of trial samples.