Rectal CancerPhase 2NCT05254327
Trial of the Efficacy and Safety of Short and Long Course Radiation Therapy With/Without BMX-001
A Phase 2 study testing BMX-001 in people with Rectal Cancer, run by University of Nebraska at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- BMX-001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Aug 2022to Jun 2034
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with pathologically confirmed locally advanced rectal adenocarcinoma who will be receiving total neoadjuvant therapy regimen with curative intent.
- AJCC stage II to III rectal adenocarcinoma that will require total neoadjuvant therapy.
- Adult, age > or equal to 18 years (for Nebraska, age of consent is ≥19 years old)
- ECOG Performance Status 0-2
- 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:
- 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.
Who cannot join
- Breast-feeding or pregnant
- Active infection requiring IV antibiotics 7 days before enrollment
- 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
- Prior history of rectal adenocarcinoma (RAC)
- Prior history of pelvic radiotherapy for any other type of malignancy
- Known hypersensitivity or contraindication to any agent in FOLFOX or CAPOX regimen.
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- 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)
- Inadequately controlled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure > 100 mmHg)
- Active or history of postural hypotension and autonomic dysfunction within the past year
- Known hypersensitivity to BMX-001
- 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
- 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
- Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to start of study treatment
- 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.
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Markey Cancer Center
Lexington, Kentucky, 40536
Samantha F Stokely, BSN, RN, 859-323-4128, samantha.stokley1@uky.edu
Cynthia A Leedham, Ph.D, 859-257-4470, cleed2@uky.edu
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
IIT Office, 402-559-4596, IITOffice@unmc.edu
Chi Lin, MD, Ph.D
- Recruiting
UT Health San Antonio MD Anderson Cancer Center
San Antonio, Texas, 78229
Vanessa N Collazo Velez, RN, MS, 210-450-7382, collazovelez@uthscsa.edu
James J Denno, 210-450-5887, dennoj@uthscsa.edu
About this study
Official title: A Randomized Phase 2 Trial of the Efficacy and Safety of Short and Long Course Radiation Therapy With and Without BMX-001 as Part of Total Neoadjuvant Therapy in Patients With Newly Diagnosed Locally Advanced Rectal Adenocarcinoma
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.
Read the detailed description
In this trial, we will enroll patients in two cohorts:
Cohort 1: A 6 patient safety lead-in for patients receiving capecitabine prior to beginning a randomized trial for the Long Course Chemo-radiation (LCCRT) cohort. There will be trial stopping rules to review safety and PK data prior to initiating the randomized trial of patients receiving LCCRT.
Cohort 2: The Randomized Short Course Radiation (SCRT) cohort.
Cohort 1 and 2 will begin enrolling concurrently. Cohort 1 will have a safety lead-in of patients receiving LCCRT (with capecitabine). Cohort 2 will begin with the randomized study of patients receiving SCRT, while the LCCRT cohort is going through the safety lead-in portion.
There are stopping rules for the LCCRT cohort 1 pending PK analysis as well as an AE review from the treatment period plus 1 week post BMX-001 treatment for the 6 patients prior to moving on with the randomized portion of the study for the LCCRT cohort. All patients in the safety lead-in portion of the trial will receive BMX-001 (A loading dose of 28 mg/subject followed by maintenance doses of 14 mg/subject twice a week) with either SCRT or LCCRT. Patients will receive 3 cycles of FOLFOX or 2 cycles of CAPOX and then be assigned to SCRT or LCCRT prior to randomization. Patients will be randomized (stratified by gender) to BMX-001 or no BMX-001. The randomized trial in each cohort will involve SCRT or LCCRT with or without BMX-001. After conclusion of radiation, patients will then receive 6 more cycles of FOLFOX or 4 more cycles of CAPOX. Skin, GI, and GU symptoms will be measured on the day of screening, before and after RT.
- Conditions
- Rectal Cancer
- Being tested
- BMX-001
- Keywords
- Radiation
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMX-001Drug
Loading dose of 28 mg per subject, followed by maintenance doses of 14 mg per subject twice per week.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Short Chemo-Radiation Therapy (SCRT) + BMX-001 Receives: Drug: BMX-001 |
| Arm B | No intervention | Short Chemo-Radiation Therapy (SCRT) |
| Arm C | Experimental | Long Course Chemo-Radiation Therapy (LCCRT) + BMX-001 Receives: Drug: BMX-001 |
| Arm D | No intervention | Long Course Chemo-Radiation Therapy (LCCRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of BMX-001 as measured by Grade 3 and above associated with gastrointestinal Toxicities
Grade 3 and above radiation-associated gastrointestinal, genitourinary, skin and hematologic toxicity (SCRT or LCCRT) including frequency, severity and duration of rectal bleeding, rectal pain, diarrhea, dysuria, hematuria, urinary frequency, radiation dermatitis and thrombocytopenia
Measured: Three weeks (During and 2 weeks after RT)
Efficacy of BMX-001 as measured by Grade 3 and above associated with genitourinary Toxicities
Grade 3 and above radiation-associated gastrointestinal, genitourinary, skin and hematologic toxicity (SCRT or LCCRT) including frequency, severity and duration of rectal bleeding, rectal pain, diarrhea, dysuria, hematuria, urinary frequency, radiation dermatitis and thrombocytopenia
Measured: Three weeks (During and 2 weeks after RT)
Efficacy of BMX-001 as measured by Grade 3 and above associated with skin Toxicities
Grade 3 and above radiation-associated gastrointestinal, genitourinary, skin and hematologic toxicity (SCRT or LCCRT) including frequency, severity and duration of rectal bleeding, rectal pain, diarrhea, dysuria, hematuria, urinary frequency, radiation dermatitis and thrombocytopenia
Measured: Three weeks (During and 2 weeks after RT)
Efficacy of BMX-001 as measured by Grade 3 and above associated with hematologic Toxicities
Grade 3 and above radiation-associated gastrointestinal, genitourinary, skin and hematologic toxicity (SCRT or LCCRT) including frequency, severity and duration of rectal bleeding, rectal pain, diarrhea, dysuria, hematuria, urinary frequency, radiation dermatitis and thrombocytopenia
Measured: Three weeks (During and 2 weeks after RT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start15 Aug 2022
- Primary completionMay 2030 (estimated)
- Study completionJun 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- BioMimetix JV, LLC
- Responsible party
- Sponsor
- Investigators
- Chi Lin, MD, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05254327
- Sponsor's protocol ID
- 0012-22-FB
- Other IDs
- BMX-RAC-001
- Status last verified
- Sep 2026
- First submitted
- 14 Feb 2022
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Myers MS, Kosmacek EA, Liew CS, Lushnikov AJ, Chatterjee A, Marky LA, Riethoven JM, Oberley-Deegan RE. BMX-001, a clinically relevant radioprotector, can reverse radiation-induced fibrosis when given three weeks after radiation, in part, by restoring methylation. Redox Biol. 2026 Mar;90:104020. doi: 10.1016/j.redox.2026.104020. Epub 2026 Jan 10.
PubMed 41544350
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 2 Trial of the Efficacy and Safety of Short and Long Course Radiation Therapy With and Without BMX-001 as Part of Total Neoadjuvant Therapy in Patients With Newly Diagnosed Locally Advanced Rectal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05254327
- Acronym / sponsor ID
- 0012-22-FB
- Conditions
- Rectal Cancer
- Keywords
- Radiation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- BioMimetix JV, LLC
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- May 2030 (estimated)
- Study completion
- Jun 2034 (estimated)
- First posted
- 24 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this trial, we will enroll patients in two cohorts:
Cohort 1: A 6 patient safety lead-in for patients receiving capecitabine prior to beginning a randomized trial for the Long Course Chemo-radiation (LCCRT) cohort. There will be trial stopping rules to review safety and PK data prior to initiating the randomized trial of patients receiving LCCRT.
Cohort 2: The Randomized Short Course Radiation (SCRT) cohort.
Cohort 1 and 2 will begin enrolling concurrently. Cohort 1 will have a safety lead-in of patients receiving LCCRT (with capecitabine). Cohort 2 will begin with the randomized study of patients receiving SCRT, while the LCCRT cohort is going through the safety lead-in portion.
There are stopping rules for the LCCRT cohort 1 pending PK analysis as well as an AE review from the treatment period plus 1 week post BMX-001 treatment for the 6 patients prior to moving on with the randomized portion of the study for the LCCRT cohort. All patients in the safety lead-in portion of the trial will receive BMX-001 (A loading dose of 28 mg/subject followed by maintenance doses of 14 mg/subject twice a week) with either SCRT or LCCRT. Patients will receive 3 cycles of FOLFOX or 2 cycles of CAPOX and then be assigned to SCRT or LCCRT prior to randomization. Patients will be randomized (stratified by gender) to BMX-001 or no BMX-001. The randomized trial in each cohort will involve SCRT or LCCRT with or without BMX-001. After conclusion of radiation, patients will then receive 6 more cycles of FOLFOX or 4 more cycles of CAPOX. Skin, GI, and GU symptoms will be measured on the day of screening, before and after RT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: BMX-001Short Chemo-Radiation Therapy (SCRT) + BMX-001 |
| Arm B | No intervention | –Short Chemo-Radiation Therapy (SCRT) |
| Arm C | Experimental | Drug: BMX-001Long Course Chemo-Radiation Therapy (LCCRT) + BMX-001 |
| Arm D | No intervention | –Long Course Chemo-Radiation Therapy (LCCRT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with pathologically confirmed locally advanced rectal adenocarcinoma who will be receiving total neoadjuvant therapy regimen with curative intent.
- AJCC stage II to III rectal adenocarcinoma that will require total neoadjuvant therapy.
- Adult, age > or equal to 18 years (for Nebraska, age of consent is ≥19 years old)
- ECOG Performance Status 0-2
- 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)
Key exclusion criteria (17 listed)
- Breast-feeding or pregnant
- Active infection requiring IV antibiotics 7 days before enrollment
- 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
- Prior history of rectal adenocarcinoma (RAC)
- Prior history of pelvic radiotherapy for any other type of malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMX-001Loading dose of 28 mg per subject, followed by maintenance doses of 14 mg per subject twice per week. | Drug | Arm A, Arm C |
Primary outcome
Efficacy of BMX-001 as measured by Grade 3 and above associated with gastrointestinal Toxicities
Time frame: Three weeks (During and 2 weeks after RT)
Grade 3 and above radiation-associated gastrointestinal, genitourinary, skin and hematologic toxicity (SCRT or LCCRT) including frequency, severity and duration of rectal bleeding, rectal pain, diarrhea, dysuria, hematuria, urinary frequency, radiation dermatitis and thrombocytopenia
Efficacy of BMX-001 as measured by Grade 3 and above associated with genitourinary Toxicities
Time frame: Three weeks (During and 2 weeks after RT)
Grade 3 and above radiation-associated gastrointestinal, genitourinary, skin and hematologic toxicity (SCRT or LCCRT) including frequency, severity and duration of rectal bleeding, rectal pain, diarrhea, dysuria, hematuria, urinary frequency, radiation dermatitis and thrombocytopenia
Efficacy of BMX-001 as measured by Grade 3 and above associated with skin Toxicities
Time frame: Three weeks (During and 2 weeks after RT)
Grade 3 and above radiation-associated gastrointestinal, genitourinary, skin and hematologic toxicity (SCRT or LCCRT) including frequency, severity and duration of rectal bleeding, rectal pain, diarrhea, dysuria, hematuria, urinary frequency, radiation dermatitis and thrombocytopenia
Efficacy of BMX-001 as measured by Grade 3 and above associated with hematologic Toxicities
Time frame: Three weeks (During and 2 weeks after RT)
Grade 3 and above radiation-associated gastrointestinal, genitourinary, skin and hematologic toxicity (SCRT or LCCRT) including frequency, severity and duration of rectal bleeding, rectal pain, diarrhea, dysuria, hematuria, urinary frequency, radiation dermatitis and thrombocytopenia
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Derived from this study: PubMed 41544350Myers MS, Kosmacek EA, Liew CS, Lushnikov AJ, Chatterjee A, Marky LA, Riethoven JM, Oberley-Deegan RE. BMX-001, a clinically relevant radioprotector, can reverse radiation-induced fibrosis when given three weeks after radiation, in part, by restoring methylation. Redox Biol. 2026 Mar;90:104020. doi: 10.1016/j.redox.2026.104020. Epub 2026 Jan 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chi Lin, MD, PhD principal investigator
University of Nebraska
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BMX-001 in people with Rectal Cancer, run by University of Nebraska at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact IIT Office (402-559-4596, IITOffice@unmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of BMX-001 as measured by Grade 3 and above associated with gastrointestinal Toxicities (time frame: Three weeks (During and 2 weeks after RT)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05254327, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.