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 range18 Years
SexALL
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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
✓. 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.
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
✕. 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.