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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: Active Phase 1 study of Metastatic Colorectal Carcinoma and Neuropathy, sponsored by Bexion Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To determine the recommended phase 2 dose of BXQ-350, when given with mFOLFOX7 and bevacizumab, according to the investigational product (IP) related dose limiting toxicities (DLTs).
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 |
What the registry record for NCT05322590 still lists
NCT05322590 is an interventional study that assigns participants to a tested intervention. The registered 195 participants enrollment target is mid-sized for trials with a published cap, above the 80-participant average among 22 other Metastatic Colorectal Carcinoma trials with a reported enrollment target (144% higher).
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 lists 12 locations in 8 states (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.
Learn More About Clinical Trials
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Where NCT05322590's enrollment target sits among peer trials
195 3rd of 22 higher than 20 of 22 other Metastatic Colorectal Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Colorectal Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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