BXQ-350 in Newly Diagnosed Metastatic Colorectal Carcinoma (NCT05322590)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (12 Sites)
- University of Alabama at Birmingham — Birmingham, Alabama
- UC Irvine Health — Orange, California
- Pacific Hematology Oncology Associates — San Francisco, California
- Sylvester Comprehensive Cancer Center, University of Miami Hospitals and Clinics — Miami, Florida
- The University of Iowa Hospitals and Clinics — Iowa City, Iowa
- St. Elizabeth Healthcare — Edgewood, Kentucky
- University of Kentucky/Markey Cancer Center — Lexington, Kentucky
- University of Louisville, James Graham Brown Cancer Center — Louisville, Kentucky
- University Medical Center New Orleans — New Orleans, Louisiana
- Stony Brook Cancer Center — Stony Brook, New York
- Gabrail Cancer Center Research — Canton, Ohio
- University of Cincinnati Medical Center — Cincinnati, Ohio
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Metastatic Colorectal Carcinoma
- Intraperitoneal Oxaliplatin and Fluorouracil for the Treatment of Patients With Peritoneal Metastases From Colorectal Cancer — Columbus, Ohio
- Durvalumab and Tremelimumab With or Without High or Low-Dose Radiation Therapy in Treating Patients With Metastatic Colorectal or Non-small Cell Lung Cancer — Phoenix, Arizona
- TAS-102 and Oxaliplatin for the Treatment of Refractory Stage IV Colon Cancer — Elizabeth, New Jersey
- M6620 and Irinotecan Hydrochloride in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery — Los Angeles, California
- HRX215, A First Generation MKK4 Inhibitor Drug, for the Treatment of Patients With Colorectal Liver Metastasis After Undergoing a Portal Vein Embolization — Rochester, Minnesota
Explore by condition: All Metastatic Colorectal Carcinoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.