Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
BXQ-350 in Newly Diagnosed Metastatic Colorectal Carcinoma
NCT05322590 · View on ClinicalTrials.gov ↗
Study Summary
The study will assess the safety and efficacy of BXQ-350 plus modified FOLFOX7 (mFOLFOX7) and bevacizumab in participants who have newly diagnosed metastatic adenocarcinoma of the colon/rectum. The study will also evaluate if the administration of BXQ-350 with mFOLFOX7 and bevacizumab may diminish oxaliplatin induced sensory neurotoxicity, enabling participants to receive the total and planned doses of mFOLFOX7. All participants will receive BXQ-350 by intravenous (IV) infusion along with standard of care doses of mFOLFOX and bevacizumab. The study is divided into two stages: Stage 1 will be open label and will enroll participants at increasing dose levels of BXQ-350 in order to determine the Stage 2 dose. Stage 2 will be blinded; participants will receive BXQ-350 at the established Stage 1 dose or placebo.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG BXQ-350
Study Locations (12)
Kentucky
- St. Elizabeth Healthcare — Edgewood
- University of Kentucky/Markey Cancer Center — Lexington
- University of Louisville, James Graham Brown Cancer Center — Louisville
California
- UC Irvine Health — Orange
- Pacific Hematology Oncology Associates — San Francisco
Ohio
- Gabrail Cancer Center Research — Canton
- University of Cincinnati Medical Center — Cincinnati
Alabama
- University of Alabama at Birmingham — Birmingham
Florida
- Sylvester Comprehensive Cancer Center, University of Miami Hospitals and Clinics — Miami
Iowa
- The University of Iowa Hospitals and Clinics — Iowa City
Louisiana
- University Medical Center New Orleans — New Orleans
New York
- Stony Brook Cancer Center — Stony Brook
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 195 participants |
| Start Date | 2023-01-09 |
| Est. Completion | 2029-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05322590
The ClinicalTrials.gov registry entry for NCT05322590 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 195 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bexion Pharmaceuticals, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Metastatic Colorectal Carcinoma appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05322590 reports 12 study locations spanning 8 distinct geographic areas — top geographies include Kentucky, California, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05322590 about?
NCT05322590 is a clinical study titled "BXQ-350 in Newly Diagnosed Metastatic Colorectal Carcinoma". The study will assess the safety and efficacy of BXQ-350 plus modified FOLFOX7 (mFOLFOX7) and bevacizumab in participants who have newly diagnosed metastatic adenocarcinoma of the colon/rectum. The study will also evaluate if the administration of BXQ-350 with mFOLFOX7 and bevacizumab may diminish o...
What is the current status of trial NCT05322590?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 195 participants. The study started on 2023-01-09. Estimated completion is 2029-04.
What conditions does trial NCT05322590 study?
This clinical trial studies the following conditions: Metastatic Colorectal Carcinoma, Neuropathy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05322590?
The interventions under investigation include: Placebo (OTHER), BXQ-350 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05322590?
This trial is sponsored by Bexion Pharmaceuticals, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05322590 being conducted?
This trial has 12 study locations across Alabama, California, Florida, Iowa, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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