Actively Recruiting
Trial of the Efficacy and Safety of Short and Long Course Radiation Therapy With/Without BMX-001
Led by University of Nebraska · Updated on 2025-08-07
118
Participants Needed
3
Research Sites
354 weeks
Total Duration
On this page
Sponsors
U
University of Nebraska
Lead Sponsor
B
BioMimetix JV, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
In this Phase 2 study, we will conduct an efficacy and safety study of the combination of investigational drug BMX-001, with short-course radiotherapy (SCRT) or long-course chemoradiotherapy (LCCRT) as part of total neoadjuvant therapy in newly diagnosed rectal adenocarcinoma (RAC) patients.
CONDITIONS
Official Title
Trial of the Efficacy and Safety of Short and Long Course Radiation Therapy With/Without BMX-001
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with confirmed locally advanced rectal adenocarcinoma planned for total neoadjuvant therapy with curative intent
- AJCC stage II to III rectal adenocarcinoma requiring total neoadjuvant therapy
- Adults aged 18 years or older
- ECOG Performance Status of 0 to 2
- Hemoglobin at least 9.0 g/dl, ANC at least 1,500 /dl, and platelets at least 100,000 /dl
- Serum SGOT and bilirubin levels no more than 1.5 times the upper limit of normal
- Adequate kidney function: serum creatinine below 1.5 mg/dl or creatinine clearance at least 50 ml/min within 2 weeks before enrollment
- Signed informed consent before any study procedures
- Negative pregnancy test for women who can bear children at screening
- Agreement to use two effective forms of birth control during treatment and for 12 months after
- Chest, abdominal, and pelvic CT or pelvic MRI done within 8 weeks before randomization
You will not qualify if you...
- Pregnant or breastfeeding women
- Active infection needing IV antibiotics within 7 days before enrollment
- Prior unrelated cancers requiring current treatment, except certain specified low-risk cancers
- Previous rectal adenocarcinoma diagnosis
- Prior pelvic radiation for any cancer
- Allergy or intolerance to agents in FOLFOX or CAPOX chemotherapy
- Use of corticosteroids unless dose is stable or decreasing at randomization
- Uncontrolled hypertension (systolic >150 mmHg or diastolic >100 mmHg)
- History or recent symptoms of postural hypotension or autonomic dysfunction
- Known allergy to BMX-001
- Serious or active heart or brain vessel diseases within 6 months before enrollment
- History or signs of uncontrolled seizures or central nervous system disease unrelated to cancer
- Significant vascular diseases like aortic aneurysm needing surgery or recent artery thrombosis
- Prolonged QT/QTc heart interval above 450 milliseconds
- Additional risk factors for Torsades de Pointes such as heart failure or family history of Long QT Syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Markey Cancer Center
Lexington, Kentucky, United States, 40536
Actively Recruiting
2
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
3
UT Health San Antonio MD Anderson Cancer Center
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
J
Jessi E Delaney, RN, BSN
CONTACT
S
Samuel P Anderson, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here