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BMX-001 + Radiation for Rectal Cancer

Phase 2
Recruiting
Research Sponsored by Chi Lin, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with pathologically confirmed locally advanced rectal adenocarcinoma who will be receiving total neoadjuvant therapy regimen with curative intent
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up three weeks (during and 2 weeks after rt)
Awards & highlights

Study Summary

This trial is testing an investigational drug in combination with radiation therapy for patients with newly diagnosed rectal cancer. The goal is to see if the drug is effective and safe.

Who is the study for?
Adults over 18 (19 in Nebraska) with locally advanced rectal cancer who are fit for total neoadjuvant therapy can join. They must have certain blood counts, organ function tests, and imaging done recently. Pregnant or breastfeeding individuals, those with significant heart disease, uncontrolled hypertension, recent serious cardiovascular events, or a history of other cancers needing active treatment are excluded.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of BMX-001 when used with either short-course radiotherapy or long-course chemoradiotherapy in patients with newly diagnosed rectal adenocarcinoma as part of their pre-surgery treatment plan.See study design
What are the potential side effects?
Potential side effects may include typical reactions to radiation therapy such as fatigue and skin irritation. Since BMX-001 is investigational, its specific side effects aren't fully known but could be similar to other chemotherapy drugs like nausea or low blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have advanced rectal cancer and will undergo intensive treatment before surgery to try to cure it.
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I agree to use two effective birth control methods during and up to 12 months after the study.
Select...
My kidney function is good, based on recent tests.
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My rectal cancer is at a stage where it needs intensive treatment before surgery.
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I am at least 18 years old, or 19 if I live in Nebraska.
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I can take care of myself but may not be able to do active work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~three weeks (during and 2 weeks after rt)
This trial's timeline: 3 weeks for screening, Varies for treatment, and three weeks (during and 2 weeks after rt) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy of BMX-001 as measured by Grade 3 and above associated with gastrointestinal Toxicities
Efficacy of BMX-001 as measured by Grade 3 and above associated with genitourinary Toxicities
Efficacy of BMX-001 as measured by Grade 3 and above associated with hematologic Toxicities
+1 more

Side effects data

From 2022 Phase 1 & 2 trial • 29 Patients • NCT02990468
100%
Dysgeusia
100%
Dry Mouth
100%
Injection site reaction
100%
Nausea
100%
Constipation
100%
Dehydration
100%
Fatigue
100%
Oropharyngeal pain
100%
Stomatitis
100%
Vomiting
100%
Radiation skin injury
100%
Salivary duct inflammation
67%
Haemoptysis
67%
Neck pain
67%
Pain
67%
Peripheral sensory neuropathy
67%
Weight decreased
67%
Chills
67%
Cough
67%
Mucosal infection
33%
Hypoacusis
33%
Hyponatraemia
33%
Ear pain
33%
Sepsis
33%
Anal incontinence
33%
Confusional State
33%
Dysphonia
33%
Diarrhoea
33%
Dizziness
33%
Early satiety
33%
Lip infection
33%
Lymphoedema
33%
Pain in extremity
33%
Skin mass
33%
Toothache
33%
Urinary tract infection
33%
Skin infection
33%
Dyspepsia
33%
Acute kidney injury
33%
Conduction Disorder
33%
Malaise
33%
Sinus tachycardia
33%
Tinnitus
33%
Dermatitis acneiform
33%
Localised oedema
33%
Hypothyroidism
33%
Pyrexia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1: Group I
Phase 1: Group II
Phase 2: Group III

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Arm CExperimental Treatment1 Intervention
Long Course Chemo-Radiation Therapy (LCCRT) + BMX-001
Group II: Arm AExperimental Treatment1 Intervention
Short Chemo-Radiation Therapy (SCRT) + BMX-001
Group III: Arm DActive Control1 Intervention
Long Course Chemo-Radiation Therapy (LCCRT)
Group IV: Arm BActive Control1 Intervention
Short Chemo-Radiation Therapy (SCRT)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BMX-001
2017
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,277 Total Patients Enrolled
Chi Lin, MD, PhDLead Sponsor
2 Previous Clinical Trials
68 Total Patients Enrolled
University of NebraskaLead Sponsor
535 Previous Clinical Trials
1,143,788 Total Patients Enrolled

Media Library

BMX-001 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05254327 — Phase 2
Colorectal Cancer Research Study Groups: Arm C, Arm D, Arm A, Arm B
Colorectal Cancer Clinical Trial 2023: BMX-001 Highlights & Side Effects. Trial Name: NCT05254327 — Phase 2
BMX-001 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05254327 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the potential risks of taking BMX-001?

"While there is some clinical data supporting BMX-001's safety, it has not been proved effective yet and thus received a score of 2."

Answered by AI

Are we looking for more participants in this experiment?

"The listed clinical trial is not accepting patients at this time. Although, if you are interested in participating in a similar study, there are 356 other trials that may be a better fit."

Answered by AI
~78 spots leftby May 2027