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NCT05322590 · ClinicalTrials.gov registry record · Phase 1
BXQ-350 in Newly Diagnosed Metastatic Colorectal Carcinoma
A Phase 1 study of Metastatic Colorectal Carcinoma and Neuropathy, sponsored by Bexion Pharmaceuticals.
- Active
- Registry status
- Phase 1
- Development phase
- 195
- Enrollment target
- 12
- Study locations
NCT05322590 is a Phase 1 study of Metastatic Colorectal Carcinoma and Neuropathy that is active but no longer recruiting, run by Bexion Pharmaceuticals. The registered enrollment target is 195 participants, above the 80-participant average among 22 other Metastatic Colorectal Carcinoma trials with a reported enrollment target (144% higher). The trial reports 12 study locations across 8 states.
The verdict
NCT05322590, a Phase 1 study of Metastatic Colorectal Carcinoma and Neuropathy, is active but no longer recruiting, sponsored by Bexion Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 195 participants
- Enrollment target
- 12
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 195 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 80-participant average among 22 other Metastatic Colorectal Carcinoma trials with a reported enrollment target (144% higher). The listed sponsor is Bexion Pharmaceuticals, which has 6 total studies on file at ClinicalTrials.gov.
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.
NCT05322590 reports 12 study locations spanning 8 distinct geographic areas - top geographies include Kentucky, California, Ohio.
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.
What interventions are being tested in trial NCT05322590?
The interventions under investigation include: Placebo (OTHER), BXQ-350 (DRUG).
Who is sponsoring clinical trial NCT05322590?
This trial is sponsored by Bexion Pharmaceuticals, which has 6 total clinical trials registered on ClinicalTrials.gov.
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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