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 (Jun 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
Treatments studied
Other
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 →Frequently asked questions
Is NCT05254327 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior pelvic radiotherapy disqualifies patients from enrollment.
What disease stage is eligible?
Stage II or III is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages