RecruitingRectal Cancer
Trial of the Efficacy and Safety of Short and Long Course Radiation Therapy With/Without BMX-001
Eligible age
18+ yrs
Accepts
All genders
Locations
3 states
Healthy volunteers
No
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About this study
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.
Sponsor: University of Nebraska
You may qualify if…
- ✓ 1. Patients with pathologically confirmed locally advanced rectal adenocarcinoma who will be receiving total neoadjuvant therapy regimen with curative intent.
- ✓ 2. AJCC stage II to III rectal adenocarcinoma that will require total neoadjuvant therapy.
- ✓ 3. Adult, age \> or equal to 18 years (for Nebraska, age of consent is ≥19 years old)
- ✓ 4. ECOG Performance Status 0-2
- ✓ 5. Hemoglobin ≥ 9.0 g/dl, ANC ≥ 1,500 /dl, platelets ≥ 100,000 /dl (The use of transfusion or other intervention to achieve Hgb \> 9.0 g/dl is acceptable)
- ✓ 6. Serum SGOT and bilirubin ≤ 1.5 times upper limit of normal
- ✓ 7. Adequate renal function defined as follows:
- ✓ 1)Serum creatinine \< 1.5 mg/dl within 2 weeks prior to enrollment or 2)Creatinine clearance (CC) ≥ 50 ml/min within 2 weeks prior to enrollment determined by 24-hour collection or estimated by Cockcroft-Gault formula: CCr male = \[(140 - age) x (wt in kg)\]/\[(Serum Cr mg/dl) x (72)\], CCr female = 0.85 x (CrCl male) 8. Signed, written informed consent prior to completing any study specific procedures 9. Negative pregnancy test for women of child-bearing potential at the time of screening 10. Women of childbearing potential and male participants must agree to use two forms of a medically effective means of birth control throughout their participation in the treatment phase of the study and until 12 months following the last study treatment 11. Chest/Abdominal/Pelvic (CAP) CT/ pelvic MRI done within 8 weeks prior to randomization.
You may not qualify if…
- ✕ 1. Breast-feeding or pregnant
- ✕ 2. Active infection requiring IV antibiotics 7 days before enrollment
- ✕ 3. Prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ, basal cell or carcinoma of the skin, invasive cancers with a 5-year disease-free interval, resected cancer of the bladder or low-grade (Gleason 6 or less) prostate cancer
- ✕ 4. Prior history of rectal adenocarcinoma (RAC)
- ✕ 5. Prior history of pelvic radiotherapy for any other type of malignancy
- ✕ 6. Known hypersensitivity or contraindication to any agent in FOLFOX or CAPOX regimen.
- ✕ 7. Because corticosteroids are anti-inflammatory and could interrupt oxidative stress, patients will be excluded unless they are on stable or decreasing corticosteroids dose at the time of randomization.
- ✕ BMX-001 Specific Exclusion Criteria (Subjects meeting any of the following criteria are ineligible for study entry)
Where it's recruiting
Source: ClinicalTrials.gov · NCT05254327 · last updated 2025-08-07