OncoMatch/Clinical Trials/NCT05254327
Trial of the Efficacy and Safety of Short and Long Course Radiation Therapy With/Without BMX-001
Is NCT05254327 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies BMX-001 for rectal cancer.
Treatment: BMX-001 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Disease stage
Required: Stage II, III
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: pelvic radiotherapy
Prior history of pelvic radiotherapy for any other type of malignancy
Lab requirements
Blood counts
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)
Kidney function
Serum creatinine < 1.5 mg/dl within 2 weeks prior to enrollment or Creatinine clearance (CC) ≥ 50 ml/min within 2 weeks prior to enrollment determined by 24-hour collection or estimated by Cockcroft-Gault formula
Liver function
Serum SGOT and bilirubin ≤ 1.5 times upper limit of normal
Cardiac function
A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds (ms) (CTCAE grade 1)); NYHA Grade II or greater congestive heart failure (CHF); serious cardiac arrhythmia uncontrolled by medication or potentially interfering with protocol treatment
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); Serum SGOT and bilirubin ≤ 1.5 times upper limit of normal; Adequate renal function defined as follows: Serum creatinine < 1.5 mg/dl within 2 weeks prior to enrollment or Creatinine clearance (CC) ≥ 50 ml/min within 2 weeks prior to enrollment determined by 24-hour collection or estimated by Cockcroft-Gault formula; A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds (ms) (CTCAE grade 1)); NYHA Grade II or greater congestive heart failure (CHF); serious cardiac arrhythmia uncontrolled by medication or potentially interfering with protocol treatment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Markey Cancer Center · Lexington, Kentucky
- University of Nebraska Medical Center · Omaha, Nebraska
- UT Health San Antonio MD Anderson Cancer Center · San Antonio, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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