Actively Recruiting
Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
24
Participants Needed
13
Research Sites
79 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have histologically or cytologically confirmed colorectal adenocarcinoma
- Patients must have unresectable or metastatic measurable disease on imaging within 28 days before registration
- Lesions must be suitable for research biopsy for patients in the expansion cohort
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less (or Karnofsky score 60% or higher)
- Absolute neutrophil count of at least 1,500/mcL within 28 days before registration
- Platelet count of at least 75,000/mcL within 28 days before registration
- Total bilirubin less than or equal to 1.5 times institutional upper limit of normal within 28 days before registration
- AST and ALT less than or equal to 3 times institutional upper limit of normal, or 5 times for those with liver metastases within 28 days before registration
- Estimated glomerular filtration rate (eGFR) of 60 mL/min/1.73 m2 or higher within 28 days before registration
- Creatine phosphokinase (CPK) less than grade 2 elevation within 28 days before registration
- Patients on cholesterol-lowering statins must have a stable dose with no changes within 3 weeks before study start
- HIV-infected patients must be on effective therapy with undetectable viral load within 6 months
- Patients with chronic hepatitis B virus must have undetectable viral load if on suppressive therapy
- Patients with hepatitis C must have been treated and cured or have undetectable viral load if on treatment
- Patients with treated brain metastases must have no progression on follow-up imaging
- Patients with new or progressive brain metastases may be eligible if immediate CNS treatment is not required
- Patients with prior or concurrent malignancies that do not interfere with study assessments
- Patients with cardiac disease must have New York Heart Association class II or better
- Patients must be able to take oral medications
- Women of childbearing potential and men must agree to use contraception during and after study participation
- Patients must be willing and able to sign informed consent
You will not qualify if you...
- Patients with high-frequency microsatellite instability (MSI-H) or deficient DNA mismatch repair (dMMR) colorectal cancer
- Patients with prolonged QT interval (> 450 ms) on screening ECG
- Patients with unresolved adverse events from prior cancer therapy greater than grade 1, except alopecia
- Patients receiving other investigational agents
- Patients who have received prior chemotherapy including FOLFOX, FOLFIRI, FOLFOXIRI, or antiangiogenic agents like bevacizumab
- Patients with known dihydropyrimidine dehydrogenase deficiency
- Patients with allergic reactions to CA-4948 or similar agents
- Patients with gastrointestinal conditions impairing absorption or ingestion of CA-4948
- Patients with uncontrolled illnesses or conditions making participation unsafe
- Pregnant or breastfeeding women
- Patients with history of organ or stem cell transplant
- Patients with significant active bleeding or unsafe for bevacizumab
- Patients who had palliative radiation to bone metastases within 2 weeks before study
- Patients who had major surgery within 4 weeks before study
- Patients with uncontrolled hypertension
- Patients on systemic immunosuppressive medications within 14 days before randomization, except certain low-dose corticosteroids
- Patients with severe infections requiring hospitalization or recent antibiotics within 14 days before registration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
UF Health Cancer Institute - Gainesville
Gainesville, Florida, United States, 32610
Actively Recruiting
2
Memorial Hospital East
Shiloh, Illinois, United States, 62269
Actively Recruiting
3
University of Kansas Clinical Research Center
Fairway, Kansas, United States, 66205
Actively Recruiting
4
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
5
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas, United States, 66211
Actively Recruiting
6
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States, 66205
Actively Recruiting
7
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States, 63376
Actively Recruiting
8
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States, 63141
Actively Recruiting
9
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
10
Siteman Cancer Center-South County
St Louis, Missouri, United States, 63129
Actively Recruiting
11
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, United States, 63136
Actively Recruiting
12
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
13
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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