BXQ-350 in Newly Diagnosed Metastatic Colorectal Carcinoma
Public ClinicalTrials.gov record NCT05322590. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1b/2 Placebo Controlled, Double Blinded Study on the Efficacy and Safety of BXQ-350 in Combination With mFOLFOX7 and Bevacizumab in Newly Diagnosed Metastatic Colorectal Carcinoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05322590
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 195 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 9, 2023 (Actual)
- Primary completion
- Nov 2026 (Estimated)
- Completion
- Apr 2029 (Estimated)
- Last update posted
- Sep 29, 2026
2023 – 2029
United States locations
- U.S. sites
- 12
- U.S. states
- 8
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35249 | — |
| UC Irvine Health | Orange | California | 92868 | — |
| Pacific Hematology Oncology Associates | San Francisco | California | 94115 | — |
| Sylvester Comprehensive Cancer Center, University of Miami Hospitals and Clinics | Miami | Florida | 33136 | — |
| The University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| St. Elizabeth Healthcare | Edgewood | Kentucky | 41017 | — |
| University of Kentucky/Markey Cancer Center | Lexington | Kentucky | 40536 | — |
| University of Louisville, James Graham Brown Cancer Center | Louisville | Kentucky | 40202 | — |
| University Medical Center New Orleans | New Orleans | Louisiana | 70112 | — |
| Stony Brook Cancer Center | Stony Brook | New York | 11794 | — |
| Gabrail Cancer Center Research | Canton | Ohio | 44718 | — |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45267 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05322590, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 29, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05322590 live on ClinicalTrials.gov.