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Trial of the Efficacy and Safety of Short and Long Course Radiation Therapy With/Without BMX-001

NCT05254327 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2025-08-07

No results posted yet for this study

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.

Conditions

Interventions

DRUG

BMX-001

Loading dose of 28 mg per subject, followed by maintenance doses of 14 mg per subject twice per week.

Sponsors & Collaborators

  • BioMimetix JV, LLC

    collaborator INDUSTRY

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Chi Lin, MD, PhD · University of Nebraska

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-15
Primary Completion
2027-05-31
Completion
2029-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05254327 on ClinicalTrials.gov