RecruitingPhase 1NCT06696768

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

Phase I Clinical Trial of CA-4948 (Emavusertib) in Combination With FOLFOX Plus Bevacizumab as Frontline Treatment in Patients With Metastatic Colorectal Cancer


Sponsor

National Cancer Institute (NCI)

Enrollment

24 participants

Start Date

Jun 23, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I trial studies the side effects and best dose of CA-4948 when given together with fluorouracil, leucovorin, oxaliplatin (FOLFOX) plus bevacizumab in treating patients with colorectal cancer that has spread from where it first started (primary site) to other places in the body (metastatic). CA-4948 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The chemotherapy drugs used in FOLFOX, fluorouracil and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Leucovorin is used with fluorouracil to treat colorectal cancer. Bevacizumab is in a class of medications called anti-angiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to the tumor. This may slow the growth and spread of the tumor. Giving CA-4948 with FOLFOX plus bevacizumab may be safe, tolerable and/or effective in treating patients with metastatic colorectal cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a new experimental drug called emavusertib (CA-4948) to a standard chemotherapy regimen (FOLFOX plus bevacizumab) is safe and effective for people with colorectal cancer that has spread and cannot be surgically removed. **You may be eligible if...** - You have been confirmed by biopsy or laboratory testing to have colorectal cancer - Your cancer has spread and cannot be removed with surgery, with measurable tumors visible on imaging - You are 18 years or older - You are in good enough health to receive chemotherapy **You may NOT be eligible if...** - Your cancer does not show measurable lesions on imaging - You are unable to have a research biopsy (for the expansion portion of the study) - You have significant organ problems that would prevent safe participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALBevacizumab

Given IV

PROCEDUREBiopsy Procedure

Undergo tumor biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREComputed Tomography

Undergo CT or PET/CT

BIOLOGICALEmavusertib

Given PO

DRUGFluorouracil

Given IV

DRUGLeucovorin Calcium

Given IV

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

DRUGOxaliplatin

Given IV

PROCEDUREPositron Emission Tomography

Undergo PET/CT


Locations(13)

UF Health Cancer Institute - Gainesville

Gainesville, Florida, United States

Memorial Hospital East

Shiloh, Illinois, United States

University of Kansas Clinical Research Center

Fairway, Kansas, United States

University of Kansas Cancer Center

Kansas City, Kansas, United States

University of Kansas Hospital-Indian Creek Campus

Overland Park, Kansas, United States

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, United States

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, United States

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Siteman Cancer Center-South County

St Louis, Missouri, United States

Siteman Cancer Center at Christian Hospital

St Louis, Missouri, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

View Full Details on ClinicalTrials.gov

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NCT06696768


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