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Tests treatment safety and results for Metastatic Colorectal Carcinoma (mCRC)
Official title Safety and Efficacy of Tegavivint in Patients With Metastatic Colorectal Carcinoma
ClinicalTrials.gov ID: NCT07463599
What this study is testing
What is Tegavivint?
Tegavivint is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic colorectal carcinoma (mcrc).
Also referred to as BC2059.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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) a. RAS, BRAF, and...
- Disease progression or intolerance to ≥ 2 lines of systemic therapy for advanced/metastatic disease, including the following prior therapies unless...
- Prior treatment with trifluridine-tipiracil or fruquintinib is allowed
You likely can't join if
- 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)...
- 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...
- Malignant disease, other than that being treated in this trial. Note: Patients with basal cell carcinoma of the skin, squamous cell carcinoma of the...
See the full eligibility criteria
Who can join
- 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) a. RAS, BRAF, and MSI/ dMMR (Mismatch repair deficiency) status for each patient must be...
- 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...
- 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...
- Willingness and ability to provide tumor biopsies during screening and while on treatment. On trial, biopsies considered low risk are required, moderate risk procedures are optional, and no high-risk procedures are...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 prior to the first dose of the investigational product(s)
- 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):
- Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
- Platelets ≥ 100 × 109/L; no transfusion within 7 days prior to the screening laboratory assessment
- Hemoglobin ≥ 9 g/dL
- Total bilirubin ≤ upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN or ≤ 5 × ULN if liver function abnormalities are due to underlying liver metastasis
- Renal function
- Estimated creatinine clearance (CrCl) ≥ 50 mL/min by the Cockcroft-Gault equation using actual body weight, or
- Estimated Glomerular Filtration Rate (eGFR) ≥ 50 mL/min/1.73m2 by Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) Creatinine Equation, or
- Measured creatinine clearance ≥ 50 mL/min
- Note: If estimated CrCl or eGFR is abnormal, accurate measurement may be obtained by 24-hour urine collection to measure creatinine clearance. g. International normalized ratio (INR) ≤ 1.5 × ULN, unless the patient is...
- Washout or recovery period prior to Day 1 of Cycle 1:
- At least 21 days from the last dose of prior systemic anticancer treatment
- At least 14 days from palliative radiotherapy (≤ 10 fractions or ≤30 gray [Gy] total dose or at least 28 days from radiotherapy \> 30 Gy) to extrahepatic tumor lesions
- At least 28 days from local or loco-regional therapy of intrahepatic tumor lesions (e.g., surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol...
- At least 28 days from any major surgery and adequate wound healing has occurred. Major surgery is defined as any significantly invasive procedure into a major body cavity (abdomen, cranium etc.) and/or surgery requiring...
- Grade ≤ 1 toxicity due to any previous cancer therapy according to the NCI-CTCAE v.5. Grade 2 is allowed in case of alopecia and/or peripheral sensory neuropathy.
- Patients with past Hepatitis C virus (HCV) infection will be eligible for the trial. The treated patients must have completed their treatment at least 1 month prior to starting trial intervention and HCV viral load must...
- Patients with controlled Hepatitis B virus (HBV) will be eligible if they meet the following criteria:
- Antiviral therapy for HBV must be given for at least 4 weeks, and HBV viral load must be less than 500 IU/mL prior to first dose of trial drug. Patients on active HBV therapy with viral loads under 100 IU/mL should stay...
- Patients who are positive for anti-hepatitis B core antibody (HBcAb), negative for hepatitis B surface antigen (HBsAg), and negative or positive for anti-hepatitis B surface antibody (HBs), and who have an HBV viral...
- Patients must have adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤ 150/90 mm Hg at Screening and no change in antihypertensive medications within 1 week before...
What rules you out
- 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...
- 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...
- Lack of peripheral venous or central venous access or any condition that would interfere with drug administration or collection of trial samples.
- Inability to swallow capsules or tablets.
- Known central nervous system (CNS) involvement including carcinomatous meningitis.
- Ongoing or active infection (exception: HBV infection - see inclusion criteria).
- Patients with large varices at risk of significant bleeding that are not being treated with conventional medical intervention: beta blockers or endoscopic treatment. Assessment of varices for patients in whom...
- Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within 6 months before the start of trial medication.
- Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality, or hypertension including any of the following:
- 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...
- 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
- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for PK interactions.
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.