Can a new drug shield rectal cancer patients from Radiation's worst side effects?
NCT ID NCT05254327
First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether an investigational drug called BMX-001 can reduce severe side effects from radiation therapy in people with newly diagnosed locally advanced rectal cancer. Participants will receive either short or long course radiation therapy, with or without BMX-001, as part of their standard treatment before surgery. The study aims to see if adding BMX-001 lowers the risk of serious gastrointestinal, urinary, skin, and blood-related side effects caused by radiation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BMX-001, an investigational drug given as a loading dose followed by maintenance doses, combined with radiation therapy
- What this could lead to
- If successful, this could lead to a way to reduce severe side effects from radiation therapy in rectal cancer patients, improving their quality of life during treatment.
- What could go wrong
- This is an early-phase trial with a relatively small number of participants. The drug may not reduce side effects as hoped, and there could be unexpected side effects from the drug itself.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 118 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2022
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 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. Exclusion Criteria: 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) 8. Inadequately controlled hypertension (defined as systolic blood pressure \>150 mmHg and/or diastolic blood pressure \> 100 mmHg) 9. Active or history of postural hypotension and autonomic dysfunction within the past year 10. Known hypersensitivity to BMX-001 11. Clinically significant (i.e. active) cardiovascular disease or cerebrovascular disease, for example cerebrovascular accidents ≤ 6 months prior to study enrollment, myocardial infarction ≤ 6 months prior to study enrollment, unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure (CHF), or serious cardiac arrhythmia uncontrolled by medication or potentially interfering with protocol treatment 12. History or evidence upon physical/neurological examination of central nervous system disease (e.g. seizures) unrelated to cancer unless adequately controlled by medication or potentially interfering with protocol treatment 13. Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to start of study treatment 14. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 milliseconds (ms) (CTCAE grade 1) using the specific/usual choice by clinical center for correction factor. 15. A history of additional risk factors for Torsades de Pointes (TdP) (e.g., congestive heart failure, hypokalemia, known family history of Long QT Syndrome). Note: Inclusion of Women and Minorities Both men and women and members of all races and ethnic groups are eligible for this trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Markey Cancer Center
RECRUITINGLexington, Kentucky, 40536, United States
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UT Health San Antonio MD Anderson Cancer Center
RECRUITINGSan Antonio, Texas, 78229, United States
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University of Nebraska Medical Center
RECRUITINGOmaha, Nebraska, 68198, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A phase II study of total neoadjuvant mFOLFOX6 plus suvemcitug and enlonstobart with selective omission of pelvic radiotherapy for High-Risk Mid-Rectal locally advanced rectal cancer with MSS status
- Leveraging digital health solutions to collect Patient-Reported outcomes in rectal cancer
- Can a targeted drug conjugate outsmart advanced colorectal cancer?
- Can a platform trial match the right drug combo to each tumor?
- Laser light may help surgeons spot risky bowel connections
- MRI and microbes: a new way to predict rectal cancer outcomes?