Actively Recruiting
Evaluation of Tegavivint Safety and Dose in Patients With Metastatic Colorectal Carcinoma A Phase 1/2 Study of Tegavivint Alone and With Standard Therapies
Led by HonorHealth Research Institute · Updated on 2026-03-11
126
Participants Needed
1
Research Sites
175 weeks
Total Duration
On this page
Sponsors
H
HonorHealth Research Institute
Lead Sponsor
I
Iterion Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and initial effectiveness of tegavivint, both alone and combined with standard treatments, in patients with metastatic colorectal carcinoma (mCRC). This Phase 1/2 trial focuses on patients whose cancer has progressed despite prior therapies and includes those with specific genetic mutations such as APC and CTNNB1. The study aims to find the best dose and assess preliminary responses to this new drug in different treatment settings. The trial has multiple parts. Part 1 uses a dose escalation design to find the maximum tolerated dose and recommended Phase 2 dose of tegavivint given intravenously as monotherapy. Once established, Part 2 enrolls more patients to evaluate tegavivint alone. Part 3 tests limited dose escalation of tegavivint combined with two different standard care regimens, each to find their recommended doses. Part 4 then expands to two parallel groups to study the preliminary efficacy of these combinations. Participants will undergo tumor biopsies during screening and treatment and must have measurable disease. Their organ and marrow function will be monitored through laboratory tests before treatment. The study will track safety by recording treatment-emergent adverse events and determining the maximum tolerated and administered doses over about 24 months. Patient performance status and disease progression will be regularly assessed throughout the study.
CONDITIONS
Official Title
Safety and Efficacy of Tegavivint in Patients With Metastatic Colorectal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Male or female, 18 years of age or older
- Histologically or cytologically confirmed metastatic colorectal adenocarcinoma
- Documented RAS, BRAF, and MSI/dMMR status
- Disease progression or intolerance to at least 2 lines of systemic therapy including fluoropyrimidine, oxaliplatin, irinotecan, anti-VEGF, and if RAS wild-type, anti-EGFR therapies
- Prior treatment with trifluridine-tipiracil or fruquintinib allowed
- BRAF-mutant patients treated with a BRAF inhibitor
- Microsatellite-high or mismatch repair deficient patients treated with immune checkpoint inhibitors
- Measurable disease per RECIST 1.1
- Willing and able to provide tumor biopsies during screening and treatment
- ECOG performance status of 0 or 1
- Adequate organ and marrow function within 7 days before first dose
- Washout period from prior treatments as specified
- Grade 1 or less toxicity from prior therapies (Grade 2 allowed for alopecia or peripheral sensory neuropathy)
- Past Hepatitis C infection treated and viral load below quantification
- Controlled Hepatitis B with viral load criteria and antiviral therapy as specified
- Adequately controlled blood pressure (≤ 150/90 mm Hg) with stable medications
You will not qualify if you...
- Receiving other anti-cancer or experimental agents
- Taking strong or moderate CYP3A4/5 inhibitors or inducers that cannot be stopped before study start
- History of Gilbert's syndrome or genetic UGT1A1 conditions
- Allergic reactions to tegavivint or related compounds including certain dyes
- Other active malignancies except certain skin cancers or curatively treated cancers without recurrence for 3 years
- Lack of venous access or conditions interfering with drug administration or sample collection
- Inability to swallow capsules or tablets
- Known central nervous system involvement
- Ongoing active infections except controlled HBV
- Untreated large varices at risk of bleeding
- Recent thrombotic or embolic events within 6 months
- Significant uncontrolled heart disease or abnormalities including specified conditions
- HIV-positive patients on antiretroviral therapy
- Pregnant or breastfeeding women
- Women and men not agreeing to use effective contraception during and 6 months after treatment
- Any other significant disease or condition affecting protocol adherence or appropriateness of participation
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Trial Site Locations
Total: 1 location
1
Clinical Trials Nurse Navigator
Scottsdale, Arizona, United States, 85258
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
Frequently Asked Questions
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